A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis (NCT00601107), a randomized phase 2 study. The primary outcome is Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination.

2. Clinical Question

The study was designed to examine safety and effectiveness in people with moderate to severe chronic plaque psoriasis. Its primary endpoint was a threshold response on the Psoriasis Area and Severity Index (PASI): a reduction of at least 50 percent from baseline at Week 12 or Early Termination. The registry also posts PASI response at Week 24 or Early Termination and a physician global assessment outcome at Week 12, Week 24, or Early Termination.

The central statistical question is whether the observed proportions differed between each dose group and placebo, and how precisely those differences were estimated. A response threshold captures the proportion reaching a specified degree of improvement, rather than the average change in PASI score. That makes the outcome straightforward to interpret as a responder proportion, but it does not describe the full range of individual score changes.

The posted results report similar Week 12 response percentages across placebo and the three dose groups. The registry also includes sponsor-reported odds ratios for the primary endpoint. These data describe the recorded outcomes in this trial; they do not by themselves establish what would occur in other populations or under other study conditions.

3. Trial Design

This was a randomized, parallel-group, Phase 2 study with quadruple masking and a placebo control. The registry lists 111 participants enrolled. The trial status is completed; the recorded start was 2008-04 and primary completion was 2009-02. The registry describes participation as lasting 28 weeks, while the assigned capsules were taken once daily up to Week 24.

Participants were allocated to placebo or one of three oral doxercalciferol dose groups: 2.5 mcg/day, 5 mcg/day, or 7.5 mcg/day. The registry describes the placebo capsules as matching the doxercalciferol capsules. The official title identifies the study as multicenter, double-blind, placebo-controlled, and dose-ranging; the design fields also record quadruple masking. The registry record does not explain which roles were included in that masking designation.

The primary outcome was the percentage with at least a 50 percent reduction in PASI at Week 12 or Early Termination. The primary analysis population is described as the Full Analysis Set: safety set-evaluable participants with at least one post-baseline PASI assessment after the date of the first dose in the treatment period. The arm-specific denominators posted for this endpoint are 25 for placebo, 30 for doxercalciferol 2.5 mcg/day, 28 for doxercalciferol 5 mcg/day, and 25 for doxercalciferol 7.5 mcg/day.

The registry record does not report the randomization sequence method, allocation concealment procedure, planned sample-size justification, or detailed protocol for handling departures from assigned treatment. It also does not report a statistical analysis plan or interim-analysis plan. Those omissions limit what can be inferred about the trial's design decisions beyond the listed allocation, masking, parallel-group structure, and recorded analyses.

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: A total of 195 participants were screened of which 84 (43.1%) were screen failures; main reason for screen failure was participant did not qualify for randomization. A total of 111 participants were randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.

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.

Population: Safety Set included all randomized participants who received at least 1 dose of study medication.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination, measured over Week 12 or Early Termination.

The primary endpoint is the percentage of participants with at least a 50 percent reduction in PASI score at Week 12 or Early Termination. PASI combines affected skin area and the severity of clinical signs across body regions. The registry describes its scale as ranging from 0, no disease, to 72, maximal disease. For each region, affected area and erythema, induration, and desquamation contribute to the score.

A reduction threshold converts each participant's score change into a responder or non-responder classification. The resulting percentage answers a specific clinical-trial question: what share of the analysis group reached at least the stated reduction threshold by the stated assessment time? It does not show the average change in score, how far responders exceeded the threshold, or how close non-responders came to it.

A responder endpoint is useful because it gives an interpretable proportion and permits comparison between randomized groups. Its interpretation still depends on the chosen threshold, timing, and analysis population. The primary endpoint includes participants assessed at Week 12 or Early Termination, so it is not restricted to a single visit for every participant. The registry record does not explain how Early Termination assessments were incorporated beyond naming them in the endpoint timeframe.

The response percentages are estimates from the analysis groups, not guarantees about an individual participant's outcome. The endpoint also captures only one aspect of the disease assessment: a PASI response threshold. Other relevant outcomes, including the posted physician global assessment endpoint, are distinct measures and should not be treated as interchangeable with PASI.

7. Results Posted in the Registry

• Doxercalciferol 2.5 mcg/Day: 20.0% (6/30) versus 20.0% (5/25) on control; risk difference 0.0 percentage points (95% CI -21.2 to 21.2), risk ratio 1.00 (0.35–2.89); unadjusted two-proportion z-test p = 1.000.
• Doxercalciferol 5 mcg/Day: 17.9% (5/28) versus 20.0% (5/25) on control; risk difference -2.1 percentage points (95% CI -23.3 to 19.0), risk ratio 0.89 (0.29–2.73); unadjusted two-proportion z-test p = 0.842.
• Doxercalciferol 7.5 mcg/Day: 20.0% (5/25) versus 20.0% (5/25) on control; risk difference 0.0 percentage points (95% CI -22.2 to 22.2), risk ratio 1.00 (0.33–3.03); unadjusted two-proportion z-test p = 1.000.

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 Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination

• 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:
  • Doxercalciferol 2.5 mcg/Day: 20.0% (6/30) versus 36.0% (9/25) on control; risk difference -16.0 percentage points (95% CI -39.6 to 7.6), risk ratio 0.56 (0.23–1.35); unadjusted two-proportion z-test p = 0.185.
  • Doxercalciferol 5 mcg/Day: 21.4% (6/28) versus 36.0% (9/25) on control; risk difference -14.6 percentage points (95% CI -38.8 to 9.6), risk ratio 0.60 (0.25–1.44); unadjusted two-proportion z-test p = 0.240.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Doxercalciferol 2.5 mcg/Day and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Doxercalciferol 5 mcg/Day and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the view beyond the primary Week 12 PASI threshold. The registry posts a Week 24 PASI response endpoint and a physician global assessment endpoint at Week 12, Week 24, or Early Termination. These outcomes address related aspects of psoriasis assessment but differ in timing or measurement, so they should not be treated as direct repetitions of the primary endpoint.

Across the posted secondary results, the observed pattern does not provide a consistent basis for overturning the primary endpoint's overall reading. The Week 24 response comparisons show variation between the dose groups and placebo, but the recalculated intervals for the posted comparisons include no difference. The physician global assessment outcome is listed as a secondary outcome, but its result values are not reported in the registry record. No numerical conclusion about that endpoint can therefore be drawn from the registry results summarized for this trial.

Secondary analyses can be informative as supporting or exploratory evidence, especially when they use different assessment times or measures. However, multiple outcomes and multiple dose comparisons create more opportunities for apparently notable findings to arise by chance. If each comparison is evaluated separately without adjustment, its p-value does not account for the full set of comparisons. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting the secondary outcomes.

Accordingly, unadjusted secondary results carry less confirmatory weight than the primary endpoint. They may suggest questions for further study, but they should not be selected in isolation to support a general claim about treatment effects. The record does not report enough information to determine whether the secondary analyses were prespecified in a detailed statistical analysis plan or how the investigators intended them to be prioritized.

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

• Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination
• Percentage of Participants With Static Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary: each participant either reached at least a 50 percent PASI reduction by Week 12 or Early Termination, or did not. For this kind of outcome, the arm-level percentage estimates the observed response proportion among participants included in that analysis group. Comparing these proportions gives a direct description of response frequency, while a confidence interval describes uncertainty around the estimated contrast.

What does the risk difference express?

The recalculated comparisons use a risk difference: the response proportion in a doxercalciferol group minus the response proportion in placebo. A value of 0.0 means the observed proportions were the same on the proportion scale. A negative estimate means the observed proportion was lower in the doxercalciferol group; a positive estimate would mean it was higher. These are simple unadjusted calculations from the posted group summaries. They do not adjust for participant characteristics or other covariates.

The reported recalculated risk differences for the primary endpoint were 0.0 for 2.5 mcg/day, -0.021 for 5 mcg/day, and 0.0 for 7.5 mcg/day. The estimates describe the observed contrasts, not a causal effect free of uncertainty. Randomization supports comparisons between assigned groups, but the analysis still depends on the quality and completeness of outcome data and on the assumptions of the chosen statistical method.

How should a confidence interval be read?

In general, a confidence interval is a range of values compatible with the data under a statistical procedure and its assumptions. It shows how much uncertainty surrounds an estimate. A narrow interval indicates greater precision; a wide interval indicates less precision. If an interval for a risk difference includes 0.0, the data do not rule out no difference at the confidence level used. That does not establish that the true difference is exactly zero.

For these primary comparisons, the recalculated intervals are -0.212 to 0.212 for 2.5 mcg/day, -0.233 to 0.19 for 5 mcg/day, and -0.222 to 0.222 for 7.5 mcg/day. Each includes 0.0 and extends in both directions. This is consistent with the small observed contrasts and also shows that the data do not estimate those contrasts precisely. The registry's sponsor-reported analyses use odds ratios and their own confidence intervals; those are a different effect scale and are discussed separately.

What does a p-value contribute?

In general, a p-value measures how unusual the observed data, or data more extreme, would be under a specified null hypothesis and statistical model. It is not a measure of the size or importance of an effect, nor is it the probability that the null hypothesis is true. The unadjusted recalculated p-values for the primary comparisons were 1.0, 0.842, and 1.0. They do not show evidence against the null in these comparisons. They should not be interpreted as proof that doxercalciferol and placebo have identical response rates.

The registry separately reports exact logistic regression analyses of odds ratios. An odds ratio compares the odds of response between groups rather than subtracting response proportions. Exact logistic methods are designed for situations where the data are sparse or where standard large-sample approximations may be unreliable. The reported odds ratios and p-values are sponsor analyses; the unadjusted recalculations are not a substitute for those analyses or their stated model.

What do the planning illustrations mean?

The registry includes planning illustrations based on observed effects for selected secondary comparisons. In general, a sample-size calculation estimates how many participants per arm would be needed to detect a specified effect under chosen assumptions. These illustrations are not observed power, and they do not establish the sample size originally planned for this trial. The record states that the illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect set to a stated fraction of the observed effect. The registry record does not report the trial's own sample-size justification.

Calculations based on an observed effect can be unstable, especially when the observed contrast is small or uncertain. Smaller assumed effects generally require larger samples to detect under otherwise fixed assumptions. The planning figures should therefore be read as scenarios rather than recommendations or evidence that a future study would produce the same effect. The registry record does not state that these calculations were part of the original protocol.

Finally, the endpoint's analysis population and assessment timing matter. The Full Analysis Set definition requires at least one post-baseline PASI assessment after the first treatment-period dose. In general, excluding participants without such an assessment can affect comparability if missingness is related to treatment or outcome. The registry record does not provide enough detail to assess that possibility, the handling of all missing outcomes, or whether additional adjusted or sensitivity analyses were performed.

11. Confidence Intervals and Precision

The primary risk-difference confidence intervals are wide relative to the observed contrasts. For doxercalciferol 2.5 mcg/day versus placebo, the recalculated estimate was 0.0, with an interval from -0.212 to 0.212. For 5 mcg/day, the estimate was -0.021, with an interval from -0.233 to 0.19. For 7.5 mcg/day, the estimate was 0.0, with an interval from -0.222 to 0.222. Each interval includes no difference and also allows for differences in either direction.

In general, a confidence interval conveys both the estimate and its precision. The point estimate alone can make a comparison look settled when it is not; the interval shows the range of effects that remain compatible with the observed data under the calculation method. Here, the observed risk differences are close to 0.0, but the intervals are much wider than those point estimates. The results therefore do not precisely distinguish small or moderate group differences from no difference.

The arm denominators for the primary endpoint were 25, 30, 28, and 25, respectively. With a binary response and these group sizes, the number of observed responses is limited, which contributes to uncertainty. The intervals should not be read as proving that every value within them is equally likely, or that values outside them are impossible. They are estimates of uncertainty under a statistical procedure.

The sponsor-reported odds-ratio intervals are also broad: 0.17 to 4.22, 0.13 to 4.14, and 0.15 to 4.59 for the three dose comparisons. These intervals include 1, the value representing equal odds, and span substantially lower and higher odds. The odds-ratio scale is not the same as the risk-difference scale, so the intervals should not be compared as if they measured the same quantity.

Precision is distinct from clinical importance. The registry record does not specify a minimum clinically important difference for this endpoint, so the clinical importance of any particular contrast cannot be assessed from a threshold declared in the record. The main statistical message is that the posted primary estimates are close to no difference, but uncertainty remains substantial.

12. Analyses Reported by the Sponsor

For the primary endpoint, the sponsor-reported analyses use exact logistic regression and report odds ratios comparing each doxercalciferol group with placebo. The reported odds ratios were 0.84 for 2.5 mcg/day, 0.76 for 5 mcg/day, and 0.85 for 7.5 mcg/day. Their respective 95% confidence intervals were 0.17 to 4.22, 0.13 to 4.14, and 0.15 to 4.59; the reported p-values were 1.000, 0.992, and 1.000.

The recalculated comparisons use unadjusted risk differences derived from the posted responder counts and denominators. They are not intended to reproduce the sponsor's exact logistic regression. Odds ratios compare odds, while risk differences compare response proportions by subtraction; different scales and methods can produce estimates that are not numerically alike. The broad sponsor intervals also indicate substantial uncertainty in the odds-ratio estimates.

The registry records no discrepancy between the posted summary statistics and the recalculated analysis. The sponsor's analysis remains the trial's reported analysis, while the recalculation is a separate, simple unadjusted comparison. Neither should be interpreted without its uncertainty, and neither changes the fact that the posted primary response proportions were similar across the arms.

13. Multiplicity, Missing Data and Analysis Populations

The primary outcome includes three comparisons with placebo, one for each doxercalciferol dose. The registry also lists secondary PASI and physician global assessment outcomes, with more than one assessment time. When many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. In general, multiplicity procedures may control that risk by adjusting significance thresholds or by specifying a testing hierarchy. The registry record does not report a multiplicity adjustment, a hierarchy for testing, or a detailed analysis plan explaining how the outcomes were prioritized.

The reported primary p-values and recalculated p-values are therefore best understood as individual, unadjusted comparisons. They do not represent a family-wise conclusion across every dose and endpoint. The posted estimates themselves remain useful descriptive comparisons, but isolated p-values should not be used to imply a confirmatory finding when the handling of multiple tests is not reported.

The primary endpoint population is defined as safety set-evaluable participants with at least one post-baseline PASI assessment after the first treatment-period dose. That definition helps identify who contributed to the primary analysis, but the registry record does not report how many otherwise eligible participants lacked a post-baseline assessment, why assessments were missing, or how missing outcome data were handled in detail. It does not report imputation methods, sensitivity analyses, or analyses under alternative assumptions about missing responses.

In general, missing data can affect a comparison if the probability of missingness differs between groups or is related to response. Requiring a post-baseline assessment may also mean that the analysis population differs from the randomized population. These are considerations for interpreting the estimates, not evidence that bias occurred in this trial. The registry record does not provide enough detail to evaluate that possibility.

The registry lists safety results for groups whose denominators differ from those for the primary efficacy analysis. It does not report a complete account connecting the safety population, the Full Analysis Set, and all randomized participants. The record also does not report a protocol-level description of handling treatment discontinuation, early termination, or other intercurrent events beyond including Early Termination in several endpoint timeframes.

14. Safety Results

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

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: blood creatinine increased (4.0%), blood urea increased (4.0%), glomerular filtration rate decreased (4.0%), hypercalcaemia (4.0%), atrial fibrillation (3.6%).

The registry posts serious adverse event counts of 0 in the placebo group, 2 in the 2.5 mcg/day group, 1 in the 5 mcg/day group, and 1 in the 7.5 mcg/day group. The corresponding serious-event at-risk denominators are 27, 31, 28, and 25. For other adverse events, the posted affected-participant counts are 8, 16, 14, and 5, with at-risk denominators of 27, 31, 28, and 25, respectively.

These are descriptive safety counts. They do not establish that an event was caused by the assigned treatment, and differences in counts should not be interpreted as definitive comparisons without accounting for uncertainty, exposure, and the way events were collected. The registry lists serious-event terms including blood creatinine increased, blood urea increased, glomerular filtration rate decreased, hypercalcaemia, atrial fibrillation, and retinal detachment, with the listed percentages ranging from 3.2% to 4.0%. The record does not provide enough context in these figures to make causal conclusions about individual terms.

Deaths are not reported in the registry record. The safety results should be read alongside the fact that their denominators differ from those used for the primary PASI outcome. The registry record does not report detailed event definitions, exposure-adjusted rates, or a complete account of event timing in relation to treatment.

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

The primary results describe the proportion of participants in each analysis group who met the PASI response threshold at Week 12 or Early Termination. The observed percentages were similar across placebo and all three doxercalciferol groups. The recalculated risk differences were close to 0.0, while their confidence intervals were broad and included differences in either direction.

That pattern does not establish that the groups are equivalent. An equivalence conclusion ordinarily requires a prespecified margin defining what differences are small enough to count as equivalent, along with a design and analysis suited to that question. The registry record does not report an equivalence margin or an equivalence objective. Nor do non-significant comparisons prove that there is no treatment effect.

At the same time, the posted data do not show a clear separation in primary responder proportions. The statistical interpretation should stay close to that observation and its uncertainty, rather than turning a non-significant result into a claim of no effect or turning small differences in point estimates into evidence of a dose response. The registry record does not report a prespecified dose-trend analysis.

The result applies to the participants and analysis population represented in this study, with its listed endpoint definition, assessment period, and missing-data reporting. It does not establish what would happen in a different population, with a different treatment duration, or under different clinical conditions. The study's recorded status is completed, but the registry data do not provide a complete account of all trial procedures or participant-level outcomes.

Safety counts are also descriptive and should not be read as proof of causation or as a complete measure of the comparative safety profile. The registry lists serious and other adverse event counts, but the available record does not provide all details needed to account for event severity, timing, exposure, or attribution. No medical decision should rest on these summary statistics alone.

In short, the primary endpoint results are compatible with little observed difference, but they are not precise enough to rule out other differences. The posted data support a cautious description of this Phase 2 study rather than a broad conclusion that doxercalciferol is effective, ineffective, equivalent to placebo, or associated with a particular safety profile.

16. Why This Trial Matters Statistically

This trial illustrates why the point estimate and its precision need to be considered together. The primary response percentages were close across groups, and the recalculated risk differences were near 0.0. Yet the confidence intervals were broad. A reader who considers only the point estimates may overstate how much the study can establish; a reader who considers only the p-values may mistake a lack of strong evidence for proof of no effect.

It also demonstrates how endpoint choice shapes interpretation. PASI response at a threshold is easy to express as a percentage, but it does not preserve information about the full distribution of score changes. The Week 24 PASI outcome and physician global assessment provide different perspectives, but they introduce additional comparisons and should be interpreted with appropriate caution about multiplicity.

The study has several randomized dose groups and placebo, making it possible to describe outcomes across dose levels. However, the observed percentages do not display a clear ordered pattern across the doses. The registry record does not report a prespecified trend test or detailed dose-response model, so the data should not be used to claim a particular dose-response relationship.

Finally, the study is a reminder that registry reporting has boundaries. The record defines the primary analysis population and reports sponsor analyses, but does not report several details needed to assess sample-size rationale, missing-data handling, multiplicity, and broader analysis choices. Recognizing those limits is part of sound statistical interpretation: the available estimates can be described accurately without treating unreported methods as known.

17. 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.

Several limitations specific to this trial affect interpretation. The primary endpoint is a dichotomized PASI change at a 50 percent threshold. This provides a responder proportion but discards information about the magnitude of score changes within the responder and non-responder categories. The registry does not post a continuous change-from-baseline summary for the primary endpoint in the record.

The primary analysis population required at least one post-baseline PASI assessment. The record does not report the number or reasons for missing assessments, how early termination was handled beyond its inclusion in the endpoint timeframe, or whether sensitivity analyses were used. These omissions prevent a full assessment of how missing outcomes may affect the estimates.

The sponsor's reported primary analyses are odds ratios from exact logistic regression, while the recalculations are unadjusted risk differences. These measures answer related but different questions and rely on different methods. The registry does not report covariate adjustments for the sponsor analysis or a detailed statistical analysis plan, so further assumptions about model specification should not be made.

The registry record does not report a multiplicity strategy for the several dose comparisons and secondary outcomes. It also does not report a sample-size justification, interim-analysis plan, prespecified clinically important difference, or detailed dose-trend analysis. The planning illustrations based on observed effects are not evidence of the trial's original design assumptions.

Safety summaries have denominators that differ from the primary efficacy denominators, and the record does not provide detailed exposure-adjusted event rates, event timing, or full attribution information. Deaths are not reported in the registry record. These limits mean the safety counts are descriptive, not a complete basis for causal comparisons.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis — NCT00601107.
• Registry record last updated 2014-05-05; status last verified 2014-04.
• Results first posted 2014-05-05.
• 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.

21. Record Summary

NCT00601107 is a completed randomized, parallel-group, quadruple-masked Phase 2 study of oral doxercalciferol versus matching placebo in participants with moderate to severe chronic plaque psoriasis. The registry lists 111 enrolled participants and three daily dose groups: 2.5 mcg/day, 5 mcg/day, and 7.5 mcg/day.

The primary endpoint was the percentage with at least a 50 percent reduction in PASI at Week 12 or Early Termination. The observed response percentages were 20.0% for placebo, 20.0% for 2.5 mcg/day, 17.9% for 5 mcg/day, and 20.0% for 7.5 mcg/day. Recalculated unadjusted risk differences were close to 0.0, with broad confidence intervals that included no difference and differences in either direction.

The registry also posts secondary outcomes and sponsor-reported exact logistic regression analyses. The available record does not report detailed multiplicity or missing-data methods, a sample-size justification, or a complete statistical analysis plan. The results are therefore best read as an uncertain comparison of observed outcomes in this trial, not as definitive evidence of equivalence or a broad treatment effect.