Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis (NCT03504852), a randomized phase 3 study. The primary outcome is Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set).

2. Clinical Question

3. Trial Design

This was a randomized, quadruple-masked, parallel-group phase 3 study sponsored by Novartis Pharmaceuticals. The registry lists an enrollment of 331 and describes the condition as moderate to severe chronic plaque-type psoriasis. The study status is completed. The listed start date is 2018-06-25, and the primary completion date is 2019-09-13.

The central efficacy comparison is between secukinumab 300 mg every 2 weeks and secukinumab 300 mg every 4 weeks. Both schedules began with 2 injections of secukinumab 150 mg once weekly up to week 4; subsequent dosing followed the assigned interval. The primary efficacy assessment was at 16 weeks. The reported primary comparison includes 165 participants in the every-2-weeks group and 166 in the every-4-weeks group.

The registry also describes an every-4-weeks non-responder up-titration group. Participants in that group received every-4-weeks dosing through week 16 and then every-2-weeks dosing. This group did not contribute a result to the primary efficacy outcome. The safety results separately list the every-2-weeks group, the every-4-weeks safety group, and the non-responder up-titration group. The registry record does not provide further detail about the masking procedures, randomization method, or allocation concealment.

The listed design identifies the study as randomized and parallel, but the registry record does not report the original sample-size justification, planned analysis details, or how the study handled deviations from assigned treatment. Those details should not be inferred from the reported enrollment or results.

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.

Before assignment: 331 participants in the study were randomized and 330 participants were treated. (One participant in the Secukinumab 300 mg Q4W arm was randomized but not treated. This participant was included in the randomization (demographic and disposition) set and the full analysis set, but was not included in the safety (Adverse Events) set.)

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full analysis set. Please note that the Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) arm did not apply to this efficacy outcome measure and therefore no results are reported here for this arm.

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set), measured over 16 weeks.

The primary endpoint counts participants who achieved PASI 90 at week 16. A participant met the endpoint by reducing the baseline Psoriasis Area and Severity Index (PASI) score by 90% or greater at that assessment. PASI evaluates erythema, thickening, and scaling separately across the head, trunk, upper limbs, and lower limbs. The registry describes scores ranging from 0, indicating no signs of psoriasis, to a theoretical maximum of 72.0, with higher scores representing greater severity.

This is a binary endpoint: each participant either meets the PASI 90 response definition at the specified assessment or does not. The reported outcome is the number of responders among the participants in the analysis population. Comparing the responder proportions between randomized groups gives a clinically interpretable summary of how frequently the defined level of improvement was observed under each regimen during the assessment period.

The endpoint is tied to a particular time point and threshold. It does not describe the full trajectory of PASI scores, the amount of improvement among participants who did not reach PASI 90, or outcomes after week 16. Nor does a group-level responder comparison establish what would happen for an individual participant. The primary efficacy population is identified as the full analysis set. The registry record notes that no primary efficacy results are reported for the non-responder up-titration group.

7. Results Posted in the Registry

• Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose): 55.4% (92/166) versus 73.3% (121/165) on control; risk difference -17.9 percentage points (95% CI -28.0 to -7.8), risk ratio 0.76 (0.64–0.89); 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.

Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose): 65.7% (109/166) versus 73.9% (122/165) on control; risk difference -8.3 percentage points (95% CI -18.1 to 1.6), risk ratio 0.89 (0.77–1.02); unadjusted two-proportion z-test p = 0.101.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary results provide a less conclusive picture than the primary PASI 90 comparison. The posted IGA analysis favors the every-2-weeks group in its point estimate, but the recalculated confidence interval includes zero. The registry’s own IGA analysis reports a borderline p-value and a confidence interval that also includes zero. This illustrates why estimates, intervals, and testing results should be read together rather than relying on a single threshold.

The other listed secondary outcome concerns deaths, serious adverse events, other clinically significant adverse events, and related discontinuations over the entire study period. The registry posts safety counts, but does not provide a treatment-effect estimate or an inferential comparison for this outcome in the information available. It therefore adds descriptive safety information, not a second efficacy test that confirms or refutes the primary finding.

Secondary outcomes can help show whether the overall pattern is consistent across different measures, but each outcome may capture a different aspect of response or safety. They also involve additional opportunities for chance findings when many outcomes are tested. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting secondary analyses. Without that information, unadjusted secondary p-values carry less weight than the designated primary endpoint and should be treated as supportive or exploratory rather than as independent confirmation.

The secondary outcomes do not change what the primary comparison measures: PASI 90 response at week 16. Nor do they establish a comprehensive benefit-risk comparison. The IGA result is another week-16 efficacy measure; the safety outcome covers the study period and uses different event definitions and analysis populations. Their distinct roles and uncertainty should remain clear when interpreting the trial as a whole.

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

• Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)
• Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary, because each participant is classified as either a PASI 90 responder or not at week 16. For a binary endpoint, a group’s response proportion is the number meeting the definition relative to the number in that analysis group. A risk difference compares the proportions by subtraction. It is expressed in the same direction as the order of groups used in the subtraction, so reversing the group order reverses the sign without changing the underlying contrast.

What does the risk difference describe?

The recalculated primary risk difference is -0.179, with the every-4-weeks group minus the every-2-weeks group as the comparison order. The estimate therefore has a negative sign because the observed responder proportion is lower in the group named first. A risk difference is an absolute contrast between proportions, rather than a relative measure. Its confidence interval describes uncertainty around that contrast under the recalculation method. The registry’s own regression analysis reports a risk difference of 17.72 in the opposite direction. The two estimates should be interpreted using their stated group order and scale, not compared by sign alone.

What does the odds ratio add?

The odds ratio compares the odds of meeting the endpoint in one group with the odds in the other. Odds and proportions are related but are not interchangeable, so an odds ratio should not be read as a risk difference or as a direct percentage-point change. The registry reports an odds ratio of 2.33 for the primary endpoint, with a 95% confidence interval from 1.44 to 3.78. The analysis method is listed as logistic regression. The registry record does not describe the covariates, if any, used in that regression.

How should the p-value be read?

A p-value describes how compatible the observed data are with a specified null hypothesis under the assumptions of the analysis. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. The registry reports p < 0.001 for its primary risk-difference and odds-ratio analyses; the recalculation reports p < 0.001. The registry record does not report a complete statistical analysis plan that would clarify all testing choices.

Why use a confidence interval?

A confidence interval gives a range of effect estimates compatible with the observed data and the interval procedure. It communicates precision as well as direction. A narrow interval indicates less uncertainty about the estimated contrast than a wide interval, while an interval that includes zero for a risk difference is compatible with no difference under that method. The interpretation remains dependent on the population, endpoint definition, analysis assumptions, and handling of missing data.

Why do event counts and over-dispersion matter?

For a binary endpoint, the information is the number of participants with the event and the number assessed in each group. The primary result is not a rate of repeated events per unit of time. Over-dispersion is a general concern when count data vary more than a model assumes; it is not the central issue for this single responder classification. If a trial instead analyzed repeated events or counts, a model that accounts for extra variability could be important. The registry record does not describe such an analysis for the primary endpoint.

The recalculated estimates are simple unadjusted re-calculations from the posted group summaries. They are useful as a transparent check on the direction and approximate scale of the group contrast, but they do not reproduce the registry’s logistic regression model. Differences in estimand, scale, group order, or model specification can make the numerical values differ. The registry record does not report the original protocol’s sample-size justification, interim analysis plan, missing-data methods, or full prespecified statistical plan. Those elements cannot be reconstructed from the outcome counts.

11. Confidence Intervals and Precision

Precision is reflected in the width of a confidence interval: a narrower interval indicates a more tightly estimated contrast, while a wider interval leaves more uncertainty about its size. For the primary endpoint, the recalculated risk difference is -0.179, with a 95% confidence interval from -0.281 to -0.078. The interval lies on one side of zero, indicating that the recalculated contrast is not compatible with zero at the stated confidence level under its method. Its sign uses the every-4-weeks group minus the every-2-weeks group.

The registry’s reported primary risk difference is 17.72, with a 95% confidence interval from 7.45 to 27.98. Its positive direction corresponds to expressing the comparison in favor of the every-2-weeks group. The reported odds ratio is 2.33, with a 95% confidence interval from 1.44 to 3.78. These intervals describe the registry’s logistic regression analyses, not the same calculation as the unadjusted recalculation.

For the IGA secondary endpoint, the recalculated risk difference is -0.083, with a 95% confidence interval from -0.181 to 0.016. This interval includes zero, leaving greater uncertainty about whether the group contrast is positive or negative under the subtraction order used. The registry’s reported IGA risk-difference interval, from -1.65 to 18.20 around an estimate of 8.28, also includes zero.

Confidence intervals do not account for every potential source of uncertainty. Their interpretation depends on the analysis model and the handling of participants without endpoint data. The registry record does not report the missing-data method, and it does not provide enough information to assess whether the intervals account for all planned comparisons. Statistical precision should therefore be considered alongside the endpoint definition and analysis population.

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 planning illustrations describe participants per arm for the binary outcomes, not total events. They use the observed effect as a reference and show planning scenarios for detecting 100% of that effect, 75% of the observed effect, and 50% of the observed effect. For the primary comparison, the entries are 112 participants per arm for 80% power and 149 participants per arm for 90% power when planning for 100% of the observed effect; 193 and 257 when planning for 75%; and 419 and 560 when planning for 50%.

The assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The 80% power column gives the per-arm planning count associated with an 80% chance of detecting an effect of the specified size under those assumptions, if that effect and the assumptions hold. The 90% power column gives the corresponding planning count for a 90% chance.

Smaller target effects require more participants per arm to achieve the stated power, as illustrated by the increasing planning counts when the assumed effect moves from 100% to 75% to 50% of the observed effect. These are prospective planning illustrations based on the observed result, not the trial’s original design assumptions. The registry record does not report the trial’s original sample-size justification. This is not observed power.

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 = 0.733; treatment proportion p₁ = 0.554; average p̄ = 0.644.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6772 = 1.3274.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6653 = 0.5599.
4. n = (1.3274 + 0.5599)² / (-0.1791)² = 111.0, rounded up to 112 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 <- 0.733333333333333                          # control proportion
p1 <- 0.55421686746988                          # 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(3504852)
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 = 112 (80% power), 149 (90% power)
 75% of observed effect: n per arm = 193 (80% power), 257 (90% power)
 50% of observed effect: n per arm = 419 (80% power), 560 (90% power)
power.prop.test: 111 
Simulated power at n = 112 per arm: 0.805 (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 registry reports the sponsor’s primary analysis as logistic regression. For PASI 90 at week 16, it gives a risk difference of 17.72, with a 95% confidence interval from 7.45 to 27.98 and p < 0.001, and an odds ratio of 2.33, with a 95% confidence interval from 1.44 to 3.78 and p < 0.001. Both are labelled superiority analyses.

The recalculation uses the posted responder counts and group sizes without adjustment. It gives a risk difference of -0.179, with a 95% confidence interval from -0.281 to -0.078 and p < 0.001, using every 4 weeks minus every 2 weeks. The sponsor’s reported risk difference uses the opposite direction and a different numeric scale. Read with those conventions in mind, the analyses indicate the same direction for the primary comparison. The registry record marks no discrepancy between the posted summary and the reported analysis.

The recalculation is not a reproduction of the sponsor’s logistic regression: the registry record does not identify its covariates or provide enough detail to reproduce the model. The sponsor’s analysis is the trial’s reported inferential analysis, while the recalculation is a transparent, unadjusted comparison derived from the posted summaries. Their roles and assumptions differ.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when analyses include several endpoints, comparisons, or time points. Testing more hypotheses creates more opportunities for a result to appear statistically notable by chance. The registry lists a primary PASI 90 outcome, an IGA outcome, and safety outcomes, as well as multiple reported analyses for the efficacy comparisons. The registry record does not report whether the original statistical plan controlled the overall type I error rate, applied a formal testing hierarchy, or adjusted secondary p-values for multiplicity.

Accordingly, the primary endpoint should be distinguished from secondary findings. The primary endpoint is the stated week-16 PASI 90 comparison. Secondary results may add context, but their p-values do not necessarily have the same confirmatory interpretation, particularly when adjustment procedures are not reported. The registry’s reported label of superiority describes the analysis result, but does not by itself establish how the broader set of tests was handled.

Missing-data handling is another important uncertainty. The registry identifies the primary efficacy population as the full analysis set, but the information describing the outcome does not explain how participants without a week-16 assessment were treated, whether any imputation was used, or how protocol deviations affected inclusion. The posted group counts alone do not reveal those procedures. For safety, the registry identifies a safety set and lists risk denominators by group; the reason that the posted safety denominator differs from the enrollment figure is not reported in the registry record.

The registry record also does not report interim analyses, a complete prespecified statistical analysis plan, or the original sample-size justification. These absences limit assessment of whether the reported analyses followed a prespecified strategy and how robust the findings are to alternate missing-data assumptions. They are uncertainties about the documentation, not evidence that any particular procedure was or was not used.

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: atrial fibrillation (3.2%), tachycardia (3.2%), inguinal hernia (3.2%), cholecystitis chronic (3.2%), pneumonia (3.2%).

The safety summaries report serious adverse events, other serious or clinically significant adverse events, and deaths over the entire study period. In the every-2-weeks group, 14 of 165 participants are listed as having a serious adverse event, 66 of 165 as having another serious or clinically significant adverse event, and 0 deaths. In the every-4-weeks safety group, the corresponding counts are 18 of 134, 57 of 134, and 1 death. The non-responder up-titration group has 4 of 31 participants with a serious adverse event, 16 of 31 with another serious or clinically significant adverse event, and 0 deaths.

The all-patients summary lists 36 of 330 participants with a serious adverse event, 139 of 330 with another serious or clinically significant adverse event, and 1 death. The serious-event terms listed most often include atrial fibrillation, tachycardia, inguinal hernia, chronic cholecystitis, pneumonia, and tooth abscess, each shown as 3.2%.

These are descriptive counts. The registry record does not provide adjusted comparative safety estimates, exposure-adjusted rates, or information sufficient to attribute an event to treatment. The every-4-weeks safety groups include different treatment courses, including the up-titration group, so the listed counts should not be treated as a like-for-like randomized comparison of identical exposure periods.

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

The primary result describes a difference in the observed frequency of PASI 90 response at week 16 between two secukinumab dosing schedules in the trial population. The posted counts and the registry’s reported analysis favor the every-2-weeks group for this endpoint. The confidence intervals convey uncertainty around the estimated group contrast, and the primary interval is on one side of zero under both the registry’s reported analysis and the unadjusted recalculation.

This finding is not a guarantee of response for any individual participant. A group-level contrast does not identify which participants would respond under either schedule, and it does not describe the size of score reduction for those who did not reach the PASI 90 threshold. The endpoint is assessed at week 16; it does not by itself establish persistence of response or effects after that assessment.

The result also does not answer every clinical question about the regimens. The primary efficacy outcome does not measure all aspects of psoriasis, overall quality of life, or long-term safety. The safety counts are descriptive and do not establish that any event was caused by treatment. Nor does the trial establish how the results apply to people outside the stated population of participants weighing 90 kg or higher with moderate to severe chronic plaque-type psoriasis.

Interpretation depends on the analysis population, definitions, and missing-data procedures. The registry record does not report the full missing-data method, the original sample-size assumptions, or whether and how secondary testing was adjusted. The most defensible reading is therefore specific: the posted primary analysis supports a higher observed week-16 PASI 90 response frequency in the every-2-weeks group than in the every-4-weeks group in this trial, while broader claims require information not reported in the registry record.

18. Why This Trial Matters Statistically

This trial illustrates why a binary endpoint should be interpreted through both its observed counts and its effect estimate. Reporting the number of responders and the analysis-group size makes the endpoint concrete; the risk difference then expresses the absolute group contrast, while the odds ratio expresses a relative contrast in odds. These measures answer related but distinct questions and should not be substituted for one another.

It also shows why the direction and scale of a contrast matter. The unadjusted recalculation defines the difference as every 4 weeks minus every 2 weeks, producing a negative estimate. The registry’s reported risk difference is expressed in the reverse direction and on a different numeric scale. Without checking the comparison order, a reader could misread the sign as a disagreement rather than a convention.

The primary and secondary outcomes also demonstrate how uncertainty can differ across measures. The primary comparison has an interval that excludes zero, while the IGA secondary comparison has an interval that includes zero. A single trial may therefore provide stronger evidence for one prespecified endpoint than for another. In the absence of reported multiplicity procedures, secondary findings merit more cautious interpretation.

Finally, planning calculations based on an observed effect are not a substitute for the trial’s original design rationale. They show how target effect size and desired power affect planning needs under stated assumptions, but they cannot establish the trial’s actual planning choices. Separating observed results, model-based inference, and planning illustrations is essential to avoid treating different statistical quantities as interchangeable.

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.

The primary efficacy outcome is assessed at week 16 and does not describe longer-term efficacy. The registry record does not report the missing-data method for the full analysis set, so the effect of participants without an evaluable week-16 outcome cannot be assessed from the posted information. It also does not report the covariates used in the logistic regression or enough detail to reproduce that analysis.

The trial’s population is restricted by its stated focus on participants weighing 90 kg or higher with moderate to severe chronic plaque-type psoriasis. The registry record does not provide enough eligibility detail to determine how broadly the results apply beyond that study population. The primary efficacy outcome also excludes the non-responder up-titration group, limiting what can be concluded from the primary comparison about that treatment course.

The safety summaries cover the entire study period, but the groups include different dosing courses and the record does not provide exposure-adjusted rates or adjusted comparative safety estimates. The reason for the difference between the posted safety denominator and the enrollment figure is not reported in the registry record. Event counts alone cannot establish causation or provide a complete comparison of risk.

Finally, the record does not report the original sample-size justification, interim analysis plan, complete analysis plan, or multiplicity procedures. These omissions limit assessment of the prespecification and robustness of the reported analyses, particularly for secondary results. They should be understood as limits of the registry information, not as evidence that particular procedures were absent from the conduct of the trial.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis — NCT03504852.
• Registry record last updated 2021-10-11; status last verified 2021-10.
• Results first posted 2021-06-07.
• 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

NCT03504852 is a completed randomized, quadruple-masked, parallel-group phase 3 study of secukinumab in participants weighing 90 kg or higher with moderate to severe chronic plaque-type psoriasis. The registry lists enrollment of 331 and a primary completion date of 2019-09-13.

The primary outcome was PASI 90 response at week 16, comparing secukinumab 300 mg every 2 weeks with 300 mg every 4 weeks. The posted counts were 121 of 165 and 92 of 166, respectively. The registry’s logistic regression analysis reports a risk difference of 17.72 and an odds ratio of 2.33, both with p < 0.001. The unadjusted recalculation points in the same direction when its reverse comparison order is considered.

The IGA secondary result is less conclusive, and safety findings are presented as descriptive event counts. Missing-data methods, multiplicity procedures, and the original sample-size rationale are not reported in the registry record.