A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (NCT05223868), a randomized phase 2 study. The primary outcome is Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16.

2. Clinical Question

The central statistical question is whether the proportion meeting the PASI-75 threshold differed between each JNJ-77242113 regimen and placebo. PASI-75 reduces a graded measure of psoriasis severity to a binary outcome: each participant either reaches the improvement threshold or does not. That makes the results easy to express as percentages, while omitting how far an individual participant’s result was from the threshold.

The registry describes a dose-ranging study intended to evaluate dose response in efficacy at Week 16. The reported regimens include JNJ-77242113 25 mg QD, 50 mg QD, 25 mg BID, 100 mg QD, and 100 mg BID. The posted results allow the response percentages and comparisons with placebo to be examined, but they do not establish what dose regimen should be used in practice or answer questions about outcomes beyond the reported study period.

3. Trial Design

This was a phase 2b, randomized, double-masked, parallel-group, placebo-controlled study of JNJ-77242113 for moderate-to-severe plaque psoriasis. The registry lists enrollment of 255 and status as completed. The study start date was 2022-02-03, and primary completion was 2022-12-15.

Participants were assigned to one of five JNJ-77242113 regimens or a placebo group. The regimen labels in the posted primary results are 25 mg QD, 50 mg QD, 25 mg BID, 100 mg QD, and 100 mg BID. The arm descriptions state that participants in the active-treatment groups also received placebo to preserve masking of dose regimens. Participants in the placebo group received placebo BID. The described treatment period ran from Week 0 through Week 16.

The primary endpoint was the percentage achieving PASI-75 at Week 16. The primary analysis population was the full analysis set, defined in the registry as all randomized participants who received at least one administration of study intervention. The reported arm counts for the primary outcome range from 41 to 43 participants. These are outcome-specific group counts, not a substitute for the total enrollment figure.

The registry record does not report the original sample-size justification, the planned statistical analysis in sufficient detail to reconstruct it, or whether interim analyses were conducted. It also does not report the allocation ratio or the precise procedures used to generate and conceal randomization. Those design details should not be inferred from the arm sizes or the posted comparisons.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16, measured over Baseline (Week 0), Week 16.

The primary endpoint is the percentage of participants who achieved at least 75% improvement from baseline in PASI at Week 16. PASI combines assessments of psoriasis lesions across the head, trunk, upper extremities, and lower extremities. The registry describes assessment of erythema, induration, scaling, and the extent of involvement. Higher PASI scores indicate greater severity.

For this endpoint, the continuous PASI score is translated into a threshold outcome: participants are classified according to whether they meet PASI-75. This is a clinically interpretable way to describe the proportion reaching a substantial improvement threshold, and it permits direct comparison of response proportions across randomized groups. However, the binary classification does not show the full range of score changes. A participant just below the threshold is counted with someone whose score changed little, while participants who exceed the threshold are grouped together despite potentially different degrees of improvement.

The baseline value was defined as the closest measurement taken before or at the time of the first study drug administration. The endpoint was assessed at Week 16. It therefore addresses response at that specified time point; longer-term outcomes are not established by this endpoint. The registry record does not report the handling of missing Week 16 endpoint measurements, so the percentages should be read alongside that uncertainty rather than assuming a particular missing-data rule.

7. Results Posted in the Registry

• JNJ-77242113 25 mg QD: 37.2% (16/43) versus 9.3% (4/43) on control; risk difference 27.9 percentage points (95% CI 11.1 to 44.8), risk ratio 4.00 (1.46–10.99); unadjusted two-proportion z-test p = 0.002.
• JNJ-77242113 50 mg QD: 58.1% (25/43) versus 9.3% (4/43) on control; risk difference 48.8 percentage points (95% CI 31.7 to 65.9), risk ratio 6.25 (2.38–16.44); unadjusted two-proportion z-test p = <0.001.
• JNJ-77242113 25 mg BID: 51.2% (21/41) versus 9.3% (4/43) on control; risk difference 41.9 percentage points (95% CI 24.3 to 59.5), risk ratio 5.51 (2.07–14.67); unadjusted two-proportion z-test p = <0.001.
• JNJ-77242113 100 mg QD: 65.1% (28/43) versus 9.3% (4/43) on control; risk difference 55.8 percentage points (95% CI 39.1 to 72.5), risk ratio 7.00 (2.68–18.26); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in PASI Total Score at Week 16

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • JNJ-77242113 25 mg QD: mean -12.76 versus -3.59 on control; difference -9.17 (95% CI -13.08 to -5.26), standardized effect d = -1.04; z-test p = <0.001.
  • JNJ-77242113 50 mg QD: mean -14.56 versus -3.59 on control; difference -10.97 (95% CI -14.51 to -7.43), standardized effect d = -1.36; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for JNJ-77242113 25 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for JNJ-77242113 50 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • JNJ-77242113 25 mg QD: 25.6% (11/43) versus 2.3% (1/43) on control; risk difference 23.3 percentage points (95% CI 9.5 to 37.1), risk ratio 11.00 (1.48–81.52); unadjusted two-proportion z-test p = 0.002.
  • JNJ-77242113 50 mg QD: 51.2% (22/43) versus 2.3% (1/43) on control; risk difference 48.8 percentage points (95% CI 33.2 to 64.4), risk ratio 22.00 (3.10–156.02); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for JNJ-77242113 25 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for JNJ-77242113 50 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • JNJ-77242113 25 mg QD: 11.6% (5/43) versus 0.0% (0/43) on control; risk difference 11.6 percentage points (95% CI 2.0 to 21.2); unadjusted two-proportion z-test p = 0.021.
  • JNJ-77242113 50 mg QD: 25.6% (11/43) versus 0.0% (0/43) on control; risk difference 25.6 percentage points (95% CI 12.5 to 38.6); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for JNJ-77242113 25 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for JNJ-77242113 50 mg QD than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary results broadly follow the direction of the primary PASI-75 pattern for the secondary outcomes with arm-level values available. PASI total score change is more negative in the active-treatment groups than in placebo, while PASI-90 and PASI-100 response percentages are higher in the active-treatment groups than in placebo. These outcomes address related but distinct aspects of psoriasis response: change on the PASI scale and more stringent improvement thresholds.

This directional consistency gives context to the primary result, but it does not make the endpoints redundant. PASI-75, PASI-90, PASI-100, and mean PASI change capture different features of response. Their results also come with their own analysis populations, uncertainty, and potential missing-data considerations. The registry lists additional secondary outcomes, including investigator global assessment, body surface area, and psoriasis symptoms and signs diary measures; their specific results are not reported in the registry record described for these outcomes.

Secondary results generally carry less confirmatory weight when many endpoints and comparisons are examined without a reported multiplicity adjustment or testing hierarchy. A nominally small p-value can be less persuasive in a broad family of tests than in a single prespecified test. The registry record does not report whether the secondary analyses were adjusted for multiple comparisons. Their observed patterns are therefore useful as supportive descriptions, but should not be treated as independent confirmations of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in PASI Total Score at Week 16
• Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16
• Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16
• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
• Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
• Change From Baseline in Body Surface Area (BSA) at Week 16
• Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
• Change From Baseline in PSSD Signs Score at Week 16

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary: each participant either achieved PASI-75 at Week 16 or did not. A group percentage is the proportion meeting that definition. A comparison with placebo can be expressed as an absolute risk difference, a relative risk, or an odds ratio. Each measure answers a different question: the absolute difference describes the separation in response probabilities, while relative measures describe that separation in relation to the placebo response. The posted recalculations include risk differences, relative risks, and odds ratios; the sponsor’s reported primary comparisons are identified as Cochran-Mantel-Haenszel analyses.

The sponsor’s method is a stratified comparison for categorical outcomes. In general, Cochran-Mantel-Haenszel methods combine information across strata to estimate or test an association while accounting for the stratification used in the analysis. The registry record does not identify the stratification variables or provide enough detail to reconstruct the sponsor’s calculation. The reported results are therefore best read as the sponsor’s stated comparisons, rather than as a fully reproducible analysis from the registry summary alone.

The unadjusted recalculations use the posted arm-level summary statistics to make simple comparisons between each active group and placebo. They do not replace the sponsor’s own analysis. For the primary comparisons, the reported sponsor p-values and unadjusted recalculated p-values agree at the displayed precision: 0.002 for 25 mg QD and p < 0.001 for the remaining regimens. Agreement at the displayed precision does not imply that every detail of the underlying analyses is identical.

A p-value describes how unusual data at least as incompatible with the null comparison would be under the assumptions of a statistical test, if the null model were correct. It is not the probability that the null hypothesis is true, and it does not quantify the probability that a result arose by chance in an everyday sense. It also does not measure the size of the treatment-group difference. The response percentages and confidence intervals give complementary information about the observed magnitude and its precision.

Confidence intervals describe a range of values compatible with the observed data under the calculation method and its assumptions. For a risk difference, the interval concerns the difference in response probabilities between a regimen and placebo. If an interval excludes zero, that is consistent with a two-sided statistical test rejecting a zero difference at a corresponding significance level, assuming the same method and confidence level. The registry gives confidence intervals for the unadjusted recalculations, but does not report confidence intervals for the sponsor’s primary analyses.

The primary analysis population is described as the full analysis set, including randomized participants who received at least one administration of study intervention. This definition is not identical to saying that every randomized participant was included regardless of treatment receipt. The group denominators are reported with the endpoint results. The registry record does not explain how participants without an evaluable Week 16 measurement were handled, whether any imputation was used, or how the analysis population was applied to missing outcome data.

There are several ways a binary outcome can lose information. PASI-75 treats all participants meeting the threshold alike, even though their degree of improvement may differ. It also treats participants just short of the threshold as nonresponders. This threshold approach supports a straightforward response-rate comparison, but it should be interpreted together with continuous PASI change and other clinical measures when those results are available.

The observed group percentages are estimates, not fixed population values. Sampling variability is especially relevant when group sizes are modest. Confidence intervals make this uncertainty more visible than a point estimate alone. In general, a narrow interval indicates greater precision under the stated analysis, whereas a wide interval indicates that a broader range of values remains compatible with the data. Precision is not the same as freedom from bias: an interval does not address problems such as missing data, outcome measurement, or selective reporting.

For a binary endpoint, the amount of information depends on the event proportions as well as group sizes. General statistical reasoning indicates that rare outcomes can be estimated imprecisely, even when group counts appear similar. That matters for interpreting the posted secondary response outcomes as well as the primary endpoint. The primary placebo response is relatively low in the posted results, and differences between proportions should therefore be read with their interval estimates rather than relying only on relative measures.

The trial includes multiple treatment regimens and multiple outcomes. If many comparisons are tested, the chance of at least one nominally small p-value can increase unless the analysis accounts for multiplicity. The registry record does not report a multiplicity adjustment or a prespecified testing hierarchy for the primary and secondary results. Consequently, individual p-values should be considered in the context of the entire set of comparisons, rather than as isolated confirmations.

The planning calculations are separate from the trial’s original design assumptions. They illustrate sample sizes under stated hypothetical assumptions and observed effects. Such calculations are useful for understanding how effect size relates to planning, but they do not show the probability that this completed trial detected an effect. The registry record does not report the original sample-size justification or its assumptions.

11. Confidence Intervals and Precision

The primary endpoint percentages are based on outcome groups with 41 to 43 participants. These group sizes give context for the precision of the response estimates: a percentage based on a modest group can change noticeably with a small change in the number of participants meeting the threshold. The posted confidence intervals for the recalculated risk differences are therefore important alongside the response percentages.

A confidence interval for a risk difference concerns the contrast between an active regimen’s response probability and the placebo response probability. It is not an interval containing a specified proportion of individual participants, and it does not describe variation in how much PASI changed within a group. It represents uncertainty in the estimated group contrast under the calculation method and assumptions. The recalculated intervals are unadjusted, while the sponsor’s reported primary analyses use the Cochran-Mantel-Haenszel method.

The registry reports confidence intervals for the recalculated comparisons, but no confidence intervals for the sponsor’s primary comparisons. The intervals therefore help characterize the simple unadjusted contrasts, not necessarily every feature of the sponsor’s stratified analysis. The registry record does not state the confidence level for the sponsor’s primary results in the analysis information listed for these comparisons.

For the primary recalculated comparisons, the intervals are on the positive side of zero, consistent with the observed response proportions being higher in each active group than in placebo. The interval widths still matter: they show that the underlying difference is not known exactly, and the uncertainty varies across comparisons. A statistically significant p-value does not make an estimate precise, nor does an interval capture uncertainty from unreported missing-data handling, multiplicity, or trial conduct.

As a general principle, precision depends on both the number of observations and the variability or event frequency. Increasing sample size tends to narrow uncertainty when other conditions are comparable, but it cannot correct systematic bias. The primary estimates should thus be read as trial-specific response proportions with sampling uncertainty, not as exact forecasts for other settings.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size calculations are planning illustrations based on the observed effect, not the trial’s original design calculations. For these non-time-to-event outcomes, the entries are participants per arm, not total participants across arms and not total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect.

The 80% power column gives the illustrative participants per arm under those assumptions for an analysis with an 80% chance of detecting the specified effect if that effect were the true one and the assumptions held. The 90% power column gives the corresponding illustration for 90% power. These are planning quantities, not guarantees about a future study. They depend on the effect size used and the statistical assumptions.

The rows for 100% of the observed effect use the full observed contrast as the planning target. The rows for 75% and 50% of the observed effect use smaller target effects. Smaller effects are harder to distinguish from random variation, so they require more participants per arm under otherwise comparable assumptions. This general relationship is reflected in the planning entries.

The observed effects come from this trial and may be unstable, particularly when group sizes are modest. A planning exercise based on an observed effect should not be read as evidence that a future study will achieve the same effect. These values are not observed power: they do not measure the probability that the completed trial detected a true effect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.093; treatment proportion p₁ = 0.372; average p̄ = 0.233.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.5975 = 1.1710.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5639 = 0.4746.
4. n = (1.1710 + 0.4746)² / (0.2791)² = 34.8, rounded up to 35 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.0930232558139535                          # control proportion
p1 <- 0.372093023255814                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(5223868)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 35 (80% power), 47 (90% power)
 75% of observed effect: n per arm = 56 (80% power), 74 (90% power)
 50% of observed effect: n per arm = 109 (80% power), 146 (90% power)
power.prop.test: 34.8 
Simulated power at n = 35 per arm: 0.816 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor reported primary comparisons of each JNJ-77242113 regimen with placebo using the Cochran-Mantel-Haenszel method. The reported p-value is 0.002 for 25 mg QD versus placebo, and p < 0.001 for each of the other four regimen comparisons. The registry labels these analyses as superiority comparisons.

The posted unadjusted recalculations use arm-level counts to compare response proportions. They produce p = 0.002 for 25 mg QD and p < 0.001 for each remaining regimen, agreeing with the sponsor’s reported p-values at the displayed precision. The recalculations also provide effect estimates and confidence intervals that are not listed for the sponsor analyses in the registry summary.

These results should not be treated as interchangeable analyses. The sponsor’s method is the reported trial analysis, while the recalculations are simple unadjusted comparisons from posted summary statistics. The recalculations do not reproduce unreported stratification or other details of the sponsor’s analysis. The discrepancy indicator is false, so there is no reported disagreement between the sponsor’s p-values and the unadjusted recalculations at the precision shown.

15. Multiplicity, Missing Data and Analysis Populations

The trial reports a primary endpoint across five active-treatment comparisons with placebo, as well as multiple secondary outcome measures. Testing several hypotheses creates a multiplicity issue: when many comparisons are made, the chance of at least one small p-value under a collection of null effects can be greater than for a single test. A prespecified testing hierarchy or adjustment can help control that issue, but the registry record does not report whether either was used for the primary comparisons or the secondary outcomes.

The sponsor’s primary p-values are reported for each regimen versus placebo, and the recalculated p-values are unadjusted. They should not be read as multiplicity-adjusted evidence. The registry record does not report a global dose-response test or formal comparisons between active-treatment regimens. Consequently, the across-dose pattern is descriptive and cannot establish that one active regimen is statistically better than another.

The primary analysis population is the full analysis set, defined as randomized participants who received at least one administration of study intervention. The record does not report how missing Week 16 values were handled, whether participants were excluded for missing endpoint data, or whether any imputation or sensitivity analyses were conducted. Those details affect how the reported percentages relate to all randomized participants.

The registry record also does not report a detailed statistical analysis plan, the original sample-size justification, or interim-analysis procedures. This absence does not show that these procedures were not conducted; it means they cannot be assessed from the registry record. The result interpretation should therefore distinguish the reported outcome and analysis from unreported protections against multiplicity or missing-data bias.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: covid-19 (2.3%), infected cyst (2.3%), suicide attempt (2.3%).

The serious adverse event counts are reported by group. The registry lists 0 serious adverse events in placebo, 0 in JNJ-77242113 25 mg QD, 1 in 50 mg QD, 0 in 25 mg BID, 2 in 100 mg QD, and 0 in 100 mg BID. No deaths are reported in any of these groups. The group sizes at risk for serious adverse events range from 41 to 43.

The record also reports other adverse events affecting 10 participants in placebo, 10 in 25 mg QD, 15 in 50 mg QD, 12 in 25 mg BID, 8 in 100 mg QD, and 10 in 100 mg BID. These counts are distinct from the serious adverse event counts. The listed serious event terms are Covid-19, Infected Cyst, and Suicide Attempt, each reported as 2.3%. The registry summary does not identify the group allocation for those listed terms.

These are descriptive counts from a phase 2b study with relatively small groups and a Week 16 treatment period. They do not establish comparative safety or rule out uncommon or later events. The registry record does not provide detailed event narratives or enough information to assess the seriousness, timing, or relationship to treatment for individual events.

17. What the Result Does, and Does Not, Mean

The results show that the posted Week 16 PASI-75 response percentages were higher in each JNJ-77242113 group than in the placebo group. The sponsor reported statistically significant superiority comparisons for all five active regimens, with p = 0.002 for 25 mg QD and p < 0.001 for the other comparisons. The unadjusted recalculations agree with those p-values at the precision reported.

This describes the observed results in this completed trial; it does not prove that the same response percentages will occur in other populations or settings. The primary outcome is measured at Week 16, so the result does not establish how long responses last. Nor does PASI-75 alone describe the full distribution of PASI changes or every aspect of symptoms and functioning.

A small p-value is not a measure of clinical importance, and statistical significance does not remove uncertainty. The response estimates are based on modest group sizes, and confidence intervals for the recalculated comparisons show that the contrasts are estimated with finite precision. The registry record does not report multiplicity adjustment, missing-data handling, or all details of the sponsor’s analysis plan, which limits how strongly the individual comparisons can be interpreted.

The posted findings also do not settle comparisons among JNJ-77242113 regimens. Each reported primary test compares a regimen with placebo, not one active regimen with another. The across-regimen percentages are informative descriptively, but they are not a substitute for reported head-to-head testing or a formal dose-response analysis.

Finally, the safety counts should be interpreted as descriptive observations, not as proof of safety or harm. The trial’s size and duration limit what can be learned about uncommon or delayed events. These results are statistical evidence from one study and do not provide medical advice or a treatment recommendation.

18. Why This Trial Matters Statistically

This trial illustrates how a dose-ranging study can present several parallel comparisons against a common placebo group. The primary outcome is a binary response threshold, so the results can be read directly as the percentage meeting PASI-75 in each regimen. At the same time, the trial’s several active regimens create a multiplicity question that is important when interpreting a set of p-values.

The posted results also show why effect size and uncertainty should be considered together. A response percentage and its placebo comparison communicate more than a significance test alone: the percentage describes what was observed in each group, while a confidence interval conveys uncertainty about the contrast. Modest group sizes make that precision especially relevant.

There is a useful distinction between the sponsor’s stated stratified analysis and simple unadjusted recalculations from summary counts. The reported p-values agree at the precision shown, but the recalculations do not reproduce every detail of the sponsor’s method. Keeping that distinction clear helps prevent a summary-statistic check from being mistaken for a complete reanalysis.

The study also offers a practical example of how secondary endpoints can support interpretation without automatically confirming the primary result. Related PASI outcomes show a directionally similar pattern among the reported results, but multiple endpoints, unreported adjustment procedures, and absent details about missing-data handling all affect the weight that should be placed on those findings.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The primary endpoint is reported at Week 16, and the registry record does not report longer-term PASI-75 results. The study therefore does not establish how durable the observed response pattern is. The registry also lists a range of secondary outcomes, but specific results for several of those outcomes are not reported in the registry record available for interpretation.

Primary outcome group sizes range from 41 to 43 participants. Estimates from groups of this size have sampling uncertainty, especially for binary outcomes. The record provides no confidence intervals for the sponsor’s primary analyses, although intervals are available for unadjusted recalculations. Those recalculated intervals should not be mistaken for intervals from the sponsor’s Cochran-Mantel-Haenszel analyses.

The registry record does not report missing-data methods, the detailed statistical analysis plan, the original sample-size justification, or multiplicity procedures. This makes it difficult to assess how missing Week 16 measurements or the several outcome comparisons were handled. The record’s primary analysis population excludes randomized participants who did not receive at least one administration, according to its definition.

Primary comparisons are against placebo; formal tests between active regimens are not reported. The study’s dose-ranging purpose does not by itself establish a statistically supported ordering of regimens. The treatment period is described as Week 0 through Week 16, so the results do not address longer exposure or uncommon events that may not appear in a study of this size and duration. Generalizability beyond participants with moderate-to-severe plaque psoriasis is not established by the registry summary.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis — NCT05223868.
• Registry record last updated 2026-02-13; status last verified 2026-02.
• Results first posted 2025-12-30.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT05223868 is a completed phase 2b randomized, double-masked, parallel-group, placebo-controlled dose-ranging study of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis. The registry lists enrollment of 255 and a Week 16 primary endpoint: the percentage achieving PASI-75.

Posted PASI-75 percentages were 9.3% for placebo and 37.2%, 58.1%, 51.2%, 65.1%, and 78.6% across the five JNJ-77242113 regimens. Sponsor-reported comparisons used the Cochran-Mantel-Haenszel method; their p-values agree at the displayed precision with unadjusted recalculations. The results are specific to the trial’s analysis population and time point. Multiplicity procedures and missing-data handling are not reported in the registry record.