Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients (NCT03055494), a randomized phase 4 study. The primary outcome is Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12.

2. Clinical Question

3. Trial Design

This was a randomized, quadruple-masked, parallel-group, multicenter phase 4 study comparing secukinumab with placebo during the initial 12 weeks. The registry lists plaque psoriasis as the condition and reports 102 enrolled participants. The study is marked completed.

The assigned secukinumab regimen began at randomization, continued at Weeks 1, 2, 3 and 4, and then proceeded monthly up to Week 48. Participants initially assigned to placebo received placebo through Week 8. At Week 12, they switched to secukinumab and followed a scheduled dosing regimen up to Week 48. That switch means the Week 12 comparison addresses the initial assigned-treatment period, while the later outcomes do not preserve a continuing placebo group.

The primary outcome is a count of participants with a response of psoriasis skin lesions to treatment at Week 12, described more specifically as response in skin histology/K16 expression. The reported analysis groups include 54 participants assigned to secukinumab and 28 assigned to placebo. These are the outcome denominators, not the registry's total enrollment.

The FAS description says that patients inappropriately randomized were excluded and that patients were analyzed according to assigned treatment. The registry record does not report the planned allocation ratio or additional detail about departures from the assigned treatment. It also does not report the original sample-size justification or the trial's own power assumptions.

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: This is The Randomized Set; i.e., all randomized participants

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.

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 Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12, measured over 12 weeks.

The primary endpoint counts participants classified as having a response in skin histology/K16 expression at Week 12. It is a binary outcome: each participant contributes to the response count or does not. The registry labels the endpoint as a response of psoriasis skin lesions to treatment and describes the histology/K16 expression response as “answered no.” The record does not explain the exact classification rule or clarify that wording further.

A binary endpoint gives a direct count of participants meeting a specified response definition. Comparing the proportions in the assigned groups can describe how frequently the recorded response occurred during the initial treatment period. It does not, by itself, show the size or degree of change in histology or skin inflammation for each participant. Those details would require the response definition and underlying measurements, which are not reported in the registry record.

The endpoint was assessed at Week 12, before the placebo group switched to secukinumab. This timing allows the recorded primary comparison to be interpreted as secukinumab versus placebo under the initial assignments. It remains important to distinguish the endpoint's biological measurement from broader clinical outcomes: the registry record does not establish that this particular response measure captures every aspect of psoriasis or patient experience.

7. Results Posted in the Registry

• Secukinumab 300 mg: 79.6% (43/54) versus 3.6% (1/28) on control; risk difference 76.1 percentage points (95% CI 63.3 to 88.8), risk ratio 22.30 (3.24–153.51); 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.

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52

• 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: 61.1% (33/54) versus 71.4% (20/28) on control; risk difference -10.3 percentage points (95% CI -31.5 to 10.9), risk ratio 0.86 (0.62–1.17); unadjusted two-proportion z-test p = 0.354.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Secukinumab 300 mg and the control. The interval gives the range of effects that remain compatible with the data.

Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52

• 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: 57.4% (31/54) versus 71.4% (20/28) on control; risk difference -14.0 percentage points (95% CI -35.3 to 7.3), risk ratio 0.80 (0.58–1.12); unadjusted two-proportion z-test p = 0.214.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Secukinumab 300 mg and the control. The interval gives the range of effects that remain compatible with the data.

Change in Systolic Blood Pressure From Baseline to Week 12

• 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:
  • Secukinumab 300 mg: mean -2.60 versus -1.50 on control; difference -1.10 (95% CI -6.26 to 4.06), standardized effect d = -0.10; z-test p = 0.676.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Secukinumab 300 mg and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes span longer-term skin response, PASI 90, cardiovascular and metabolic measures, and hsCRP. The registry lists 10 secondary outcomes, but numerical results are not available for all of them in the registry record. The posted numerical results include Week 52 response, Week 52 PASI 90 and Week 12 systolic blood pressure.

Those available results do not present a uniform pattern of clear group separation. The Week 52 comparisons have confidence intervals that include zero, and the systolic blood pressure comparison is also imprecise. They differ from the primary endpoint in outcome definition, follow-up timing and, in the Week 52 comparisons, treatment history: the original placebo group had switched to secukinumab at Week 12. These outcomes therefore do not represent an ongoing placebo-controlled comparison through Week 52.

The primary result is a Week 12 response in skin histology/K16 expression. Secondary findings may help describe other aspects of the study, but they do not automatically validate or overturn the primary result. Each addresses a distinct question, and the registry does not report numerical findings for every listed secondary outcome.

Unadjusted secondary analyses carry less weight when multiple outcomes are examined because the chance of finding at least one apparently notable result can increase across repeated tests. The registry record does not report a multiplicity procedure. Secondary comparisons should consequently be read as exploratory descriptions unless the analysis plan establishes otherwise; that plan is not reported in the registry record.

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

• Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52
• Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52
• Change in Systolic Blood Pressure From Baseline to Week 12
• Change in Diastolic Blood Pressure From Baseline to Week 12
• Change in Body Weight From Baseline to Week 12
• Change in Glucose Level From Baseline to Week 12
• Change in Insulin Level From Baseline to Week 12
• Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary, so its basic summary is the number of participants meeting the response definition out of the number assessed in each group. The posted values are 43 of 54 for secukinumab and 1 of 28 for placebo. A proportion difference expresses the contrast between those group proportions in percentage-point terms. The sponsor reports that contrast as 76.1, with a 95% confidence interval from 63.3 to 88.8.

What does a confidence interval describe?

In general, a confidence interval gives a range of values compatible with the data under the method used to calculate it. It reflects sampling uncertainty; it is not a guarantee that the true effect lies within the particular interval. The sponsor's interval for the primary difference is reported at the 95% level. Its range does not include zero, which is consistent with a separation in the observed group proportions under that analysis.

How should the p-value be read?

In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null model. It is not the probability that the null hypothesis is true, nor a measure of clinical importance. The posted unadjusted recalculation gives p < 0.001 for the primary comparison. The sponsor's reported analysis does not include a p-value, so the recalculated value should remain distinct from the sponsor's result.

What does “unadjusted” mean?

The recalculated comparison is a simple, unadjusted calculation from the posted group counts. It does not incorporate covariates or other adjustments. The registry does not report enough detail to determine whether the sponsor used additional adjustment methods, so those should not be inferred. Because the sponsor's own reported analysis is available and there is no flagged discrepancy, its reported estimate and interval are the primary account of the sponsor's result.

Why do the group sizes matter?

Precision depends in part on how many participants contribute to the outcome and how common the response is. Unequal outcome denominators can also affect the uncertainty in a group comparison. The primary groups include 54 and 28 participants, so the estimate is based on a relatively limited set of outcome observations. A large observed difference does not remove the need to consider that uncertainty, the outcome definition and the analysis population.

What do the continuous secondary outcomes represent?

For continuous measures, the registry reports group means and standard deviations. For systolic blood pressure, the mean change was -2.6 mmHg in the secukinumab group and -1.5 mmHg in the placebo group; the reported mean difference was -1.1 mmHg, with a confidence interval from -6.258 to 4.058. A mean difference summarizes the contrast in average change, while the standard deviation describes variation among participants within a group. The confidence interval spanning zero indicates that the posted estimate is imprecise about the direction of the group difference.

What are the limits of these comparisons?

General statistical interpretation depends on how outcomes were defined, how missing values were handled and whether analyses were prespecified. The registry describes the primary analysis population as the FAS, excludes patients inappropriately randomized, and says participants were analyzed according to assigned treatment. It does not report the details needed to assess missing-data methods, a complete statistical analysis plan, or multiplicity control. Those absences limit how far a reader can extend the reported comparisons beyond the specific outcomes and analyses recorded.

11. Confidence Intervals and Precision

The sponsor reports a primary difference in percentages of 76.1, with a 95% confidence interval from 63.3 to 88.8. The interval communicates uncertainty around the estimated separation between the groups. It remains above zero, but it is not a single precise value: the data are compatible with a range of differences under the reported method.

The width of an interval is influenced by the amount of information in the data and by the method used. The primary analysis uses 54 participants assigned to secukinumab and 28 assigned to placebo. Those denominators are modest, and the response counts are notably different. The interval should therefore be read as an estimate with uncertainty, not as an exact measure that applies unchanged to other populations or settings.

The primary interval comes from the sponsor's reported analysis. The separate recalculation is based on posted summary counts and is not a replacement for the sponsor's method. The registry does not describe the sponsor's full calculation details, so the interval should be interpreted as reported rather than reverse-engineered.

Other endpoints are less conclusive in their precision. For Week 52 skin response, the recalculated risk difference is -0.103 with a confidence interval from -0.315 to 0.109; for PASI 90, it is -0.140 with a confidence interval from -0.353 to 0.073. Both intervals include zero. These estimates therefore leave uncertainty about the direction and size of the group contrast. The Week 12 systolic blood pressure mean difference also has an interval spanning zero. These findings are not equivalent in measurement or clinical meaning to the primary histology/K16 response.

Confidence intervals describe uncertainty in an estimate, not all sources of uncertainty. They do not address unclear outcome definitions, unreported missing-data procedures, or multiplicity. Those issues remain relevant to interpreting precision and the scope of the conclusions.

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 figures are illustrations based on observed effects, not the trial's original design justification. For these non-time-to-event outcomes, the figures are participants per arm. The assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The registry record does not report the trial's own original sample-size assumptions.

The 80% power column gives the number of participants per arm calculated for an 80% chance of detecting the assumed effect under those planning assumptions, if that effect is true. The 90% power column uses a higher target chance of detection and therefore generally calls for more participants. For the primary outcome, the planning illustration gives 6 participants per arm for 80% power and 7 for 90% power when planning for 100% of the observed effect. The corresponding figures increase when planning for 75% or 50% of the observed effect.

Smaller target effects are harder to distinguish from random variation, so they require more participants for the same power target. These examples are highly dependent on the observed effect, which may not be a stable estimate when the trial groups are limited in size. They are not a recommendation for a future study's design and do not replace a protocol-based calculation using a justified target effect and assumptions.

This is not observed power. It is a planning illustration based on the observed effect and stated assumptions, rather than a measure of how much power the completed trial actually had. The time-to-event convention of total events does not apply to the outcomes discussed in these planning figures.

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 = 0.036; treatment proportion p₁ = 0.796; average p̄ = 0.416.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6971 = 1.3662.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4434 = 0.3732.
4. n = (1.3662 + 0.3732)² / (0.7606)² = 5.2, rounded up to 6 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 <- 0.0357142857142857                          # control proportion
p1 <- 0.796296296296296                          # 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(3055494)
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 = 6 (80% power), 7 (90% power)
 75% of observed effect: n per arm = 10 (80% power), 12 (90% power)
 50% of observed effect: n per arm = 18 (80% power), 24 (90% power)
power.prop.test: 5.2 
Simulated power at n = 6 per arm: 0.905 (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's reported primary analysis gives a 76.1 difference in percentages, with a 95% confidence interval from 63.3 to 88.8. The sponsor does not report a p-value for this result in the registry record. A separate simple, unadjusted recalculation from the posted counts gives p < 0.001, but that is not the sponsor's own analysis.

The sponsor's reported difference and confidence interval are consistent with the posted group counts showing more recorded responses in the secukinumab group than in the placebo group. The recalculation is useful as a transparent check based on those counts, but it may not reproduce details of the sponsor's method that are not described in the registry. The registry does not report enough information to identify any such details.

No discrepancy is flagged between the posted summary and the sponsor's analysis. The sponsor's own analysis therefore takes precedence when stating the reported primary result. The recalculated p-value should be treated as supplemental and should not be described as a sponsor-reported finding.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies the primary outcome and lists secondary outcomes, but it does not report a multiplicity-adjustment plan. When a study examines multiple outcomes, the interpretation of individual p-values can be affected by the number of analyses performed. Without a reported plan, it is not possible to determine whether the sponsor controlled the overall chance of false-positive findings or used another prespecified approach. The unadjusted secondary results should therefore be treated cautiously.

The primary analysis population is described as the Full Analysis Set. The registry says this included patients assigned study medication, excluded patients inappropriately randomized, and followed the intent-to-treat principle by analyzing patients according to assigned treatment. The population description is truncated in the registry record, so details beyond that wording are not available.

The registry does not report how missing primary or secondary outcome values were handled, how many values were missing, or whether sensitivity analyses examined alternative assumptions. Those details matter because the effect of missing observations depends on why data are absent and how the analysis treats them. No missing-data method should be inferred from the available record.

The trial is described as randomized, quadruple-masked and parallel-group. The registry does not report a complete statistical analysis plan, interim-analysis procedures, or the trial's original sample-size justification. These omissions do not negate the recorded results, but they limit assessment of whether every analysis was planned in advance and how robust the conclusions are to analytical choices.

Finally, the placebo group switched to secukinumab at Week 12. That design feature means the Week 52 outcomes do not preserve the initial randomized placebo contrast. It is relevant to the interpretation of later outcomes, but it does not change the identity of the Week 12 primary comparison.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: testis cancer (3.6%), suicidal ideation (1.9%).

The registry reports serious adverse events affecting 1 of 54 participants in the secukinumab 300 mg group and 1 of 28 participants in the placebo/secukinumab 300 mg group. It reports zero deaths in each group. These are counts within the registry's listed safety groups; they do not, by themselves, describe the type, timing, duration or severity of every event.

The record also lists “Testis cancer” at 3.6% and “Suicidal ideation” at 1.9% among the top serious terms. It does not explain the denominator or provide enough context to attribute these terms to a particular treatment period or group. The percentages should therefore be read as listed, without inferring a group-specific rate or causal relationship.

Other adverse events were reported for 39 of 54 participants in the secukinumab group and 25 of 28 participants in the placebo/secukinumab group. Because the latter group changed treatment at Week 12, the combined group label does not represent placebo exposure throughout follow-up. The registry summaries alone do not establish whether an event was caused by study treatment or allow a complete comparative safety assessment.

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

The primary registry result shows that the recorded Week 12 skin histology/K16 response was more frequent in the secukinumab-assigned group than in the placebo-assigned group: 43 of 54 participants compared with 1 of 28. The sponsor reports a difference in percentages of 76.1, with a 95% confidence interval from 63.3 to 88.8. This is evidence of a group contrast for the specific response recorded in this trial.

The result does not establish how the response definition maps to changes that matter to patients. The registry describes the primary response as “answered no,” but does not clarify the classification rule. Nor does a binary response count describe the degree of change for each participant. Conclusions should remain tied to the recorded endpoint.

The Week 12 comparison is between the initial randomized groups. After Week 12, the placebo group switched to secukinumab, so later outcomes cannot be interpreted as a continuing comparison of secukinumab with placebo. The longer-term results address participants with different treatment histories than the initial comparison.

The study record does not report the full analysis plan, missing-data handling or multiplicity approach. The available results also do not establish effects on every secondary outcome listed. Statistical significance of the recalculated primary comparison does not, by itself, settle these questions or establish broader clinical importance.

These findings describe the registered study and its reported outcome data. They are not medical advice and should not be taken as a recommendation about treatment. The record does not support conclusions beyond the populations, outcomes and follow-up periods it describes.

18. Why This Trial Matters Statistically

This trial illustrates why an endpoint's definition matters as much as its headline count. The primary result is based on a binary histology/K16 response, but the registry's phrase “answered no” is not fully explained. Readers can interpret the reported group counts and sponsor interval while recognizing that the response rule itself remains unclear.

It also demonstrates the distinction between a prespecified sponsor analysis and a simple recalculation from summary counts. The sponsor reports a percentage difference and confidence interval, while an unadjusted recalculation supplies a p-value. Keeping those sources distinct avoids presenting a check calculation as though it were the sponsor's stated method.

The treatment switch at Week 12 is important for interpreting follow-up. The initial placebo comparison answers a different question from the Week 52 outcomes, because the original placebo group had begun secukinumab. A randomized comparison over one period does not automatically remain a randomized treatment contrast after crossover.

Finally, the trial highlights limits of registry summaries for evaluating a statistical plan. The record contains outcome counts, some estimates and safety summaries, but does not report multiplicity handling, missing-data procedures or the original sample-size justification. Those details affect how confidently secondary results and longer-term findings can be interpreted.

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 endpoint's response definition is not fully clear. The registry calls it a response in skin histology/K16 expression and includes the wording “answered no,” but does not explain the classification threshold or how the measurement was translated into a participant-level response. This makes it difficult to assess precisely what the primary count represents.

The analyzed outcome groups are limited in size, with 54 participants in the secukinumab group and 28 in the placebo group. The sponsor's interval communicates uncertainty, but the modest denominators limit the amount of information available. The registry does not report whether the analyzed groups reflect all randomized participants or provide a complete account of outcome availability.

The placebo group switched to secukinumab at Week 12. As a result, Week 52 comparisons involve a group initially assigned to placebo that later received secukinumab, rather than a group maintained on placebo. This complicates interpretation of later group differences as effects of the original assigned treatment.

The registry record does not report missing-data methods, the complete statistical analysis plan, multiplicity control, interim analyses or the trial's original sample-size justification. It also does not provide numerical results for every listed secondary outcome. These gaps restrict assessment of analytical choices and the completeness of the available outcome picture.

Safety summaries are counts and selected serious-event terms, without enough detail to assess timing, attribution or event narratives. The record's safety figures should not be interpreted as a complete causal comparison.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients — NCT03055494.
• Registry record last updated 2023-03-10; status last verified 2023-03.
• Results first posted 2020-03-10.
• 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

This completed randomized, quadruple-masked, parallel-group phase 4 study enrolled 102 participants with moderate to severe plaque psoriasis. It compared secukinumab 300 mg with placebo for the initial 12-week period, after which participants initially assigned to placebo switched to secukinumab.

The primary Week 12 response counts were 43 of 54 for secukinumab and 1 of 28 for placebo. The sponsor reported a difference in percentages of 76.1, with a 95% confidence interval from 63.3 to 88.8. A separate unadjusted recalculation gives p < 0.001; the sponsor's reported analysis did not include a p-value.

The record lists secondary skin, blood pressure, body weight, glucose, insulin and hsCRP outcomes, but numerical results are not available for all listed outcomes. Missing-data methods, multiplicity procedures and the original sample-size justification are not reported in the registry record.