This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting (NCT05701995), a randomized phase 4 study. The primary outcome is Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05701995 |
| Phase | Phase 4 |
| Condition | Psoriasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 180 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Participants with plaque psoriasis in a community setting. The primary endpoint description identifies the Full Analysis Set as all randomized participants, and also names a subpopulation of randomized participants with baseline static Physician Global Assessment (s-PGA) ≥3. The number of participants in that subpopulation is not reported in the registry record.
Intervention
Deucravacitinib. The registry record also labels an active-treatment group as deucravacitinib followed by deucravacitinib. The dose, administration schedule, and treatment duration are not reported in the registry record.
Comparator
Placebo during the placebo-controlled comparison. A group label also describes participants receiving placebo followed by deucravacitinib. The timing and details of this sequence are not reported in the registry record.
Primary question
At Week 16, what percentage of participants achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1? This endpoint describes the proportion meeting that score threshold. The group-specific percentages and their confidence intervals are not reported in the registry record.
The study’s stated purpose is to evaluate deucravacitinib’s effect on quality of life in participants with plaque psoriasis in a community setting. The registered comparison is randomized, double-blind, placebo-controlled, and parallel. Those features describe the planned structure, not the size or certainty of any treatment effect. The record lists an enrollment of 180, but that figure alone does not identify how many participants contributed to each endpoint analysis. The primary endpoint description also names a baseline s-PGA≥3 subpopulation, so its results should not be assumed to represent the entire enrolled population. The posted registry record does not report the primary endpoint’s observed percentages, uncertainty estimates, or an explicit between-group contrast. Accordingly, the record as does not allow readers to quantify the Week 16 difference between treatment groups.
3. Trial Design
This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study. Its stated aim is to evaluate the effect of deucravacitinib on quality of life in participants with plaque psoriasis in a community setting. The registry record lists enrollment of 180 and marks the study as completed. The recorded start date is 2023-01-31, and the primary completion date is 2024-08-23.
The intervention list names deucravacitinib and placebo. The group labels in the safety information distinguish a placebo-controlled period, with a deucravacitinib group and a placebo group, from active-treatment groups labelled deucravacitinib followed by deucravacitinib and placebo followed by deucravacitinib. These labels indicate that the record includes more than one treatment-period grouping. They do not, by themselves, establish the timing of any transition, the duration of each period, or which participants contributed to each analysis. Those details are not reported in the registry record.
Random allocation and masking are useful design features in general: randomization can help balance measured and unmeasured characteristics between groups, while masking can reduce some forms of expectation or assessment bias. Their presence does not guarantee that all bias is absent, and they do not reveal how the study handled missing outcomes or analyzed the endpoint. The record identifies seven analyses and ten outcome measures, but the analysis methods and the relationship between those analyses and outcome measures are not described in the available details.
The record lists the primary endpoint as the percentage of participants achieving a DLQI score of 0 or 1 at Week 16. It also lists secondary outcomes covering DLQI change, itch, physician assessment, adverse events, laboratory abnormalities, and vital signs. The specific treatment schedule, eligibility criteria beyond the described endpoint population, site count, allocation ratio, and statistical analysis plan are not reported in the registry record. The posted results therefore support a description of the study structure and outcomes, but not a complete reconstruction of its protocol.
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 180 participants were randomized and of these 178 received at least one dose of study treatment.
Pre-Treatment
| Stage | Deucravacitinib | Placebo |
|---|---|---|
| STARTED | 120 | 60 |
| Full Analysis Set Sub-population | 107 | 49 |
| COMPLETED | 119 | 59 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Deucravacitinib | Placebo |
|---|---|---|
| Randomization Error | 1 | 1 |
Placebo Controlled: Week 0-16
| Stage | Deucravacitinib | Placebo |
|---|---|---|
| STARTED | 119 | 59 |
| COMPLETED | 104 | 49 |
| NOT COMPLETED | 15 | 10 |
Reasons for not completing this period:
| Reason | Deucravacitinib | Placebo |
|---|---|---|
| Withdrawal by Subject | 8 | 4 |
| Lost to Follow-up | 2 | 3 |
| Adverse Event | 3 | 1 |
| Other Reason | 1 | 1 |
| Death | 1 | 0 |
| Physician Decision | 0 | 1 |
Active Treatment: Week 16-52
| Stage | Deucravacitinib | Placebo |
|---|---|---|
| STARTED | 103 | 49 |
| Completed Placebo Controlled Period; Did Not Enter Active Treatment Period | 1 | 0 |
| COMPLETED | 87 | 41 |
| NOT COMPLETED | 16 | 8 |
Reasons for not completing this period:
| Reason | Deucravacitinib | Placebo |
|---|---|---|
| Lost to Follow-up | 5 | 4 |
| Withdrawal by Subject | 5 | 2 |
| Lack of Efficacy | 4 | 1 |
| Adverse Event | 0 | 1 |
| Death | 1 | 0 |
| Other Reasons | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)
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.
| Characteristic | Unit | Deucravacitinib | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 120 | 60 | 180 | |
| Age, Continuous | Years | 49.1 (SD 14.92) | 47.5 (SD 13.55) | 48.6 (SD 14.46) |
| Sex: Female, Male: Female | Participants | 48 | 20 | 68 |
| Sex: Female, Male: Male | Participants | 72 | 40 | 112 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 34 | 22 | 56 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 86 | 36 | 122 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 2 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian | Participants | 5 | 1 | 6 |
| Race/Ethnicity, Customized: Black or African American | Participants | 3 | 6 | 9 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: White | Participants | 108 | 50 | 158 |
| Race/Ethnicity, Customized: Other | Participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: Unknown or Not Reported | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16, measured over At Week 16.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16. The DLQI is a participant-reported quality-of-life survey covering symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. It contains 10 questions. Each question uses a four-point scoring scale, and the scores are added to produce a total from 0 to 30. A lower total score indicates better quality of life.
The endpoint turns that score into a threshold-based outcome: it counts participants whose total is 0 or 1, then expresses them as a percentage of the relevant analysis population. In general, a threshold outcome can be straightforward to interpret as the proportion meeting a defined criterion. It also discards information about how far scores lie above or below the threshold. Two participants with different total scores may be grouped together if both fall on the same side of the cutoff.
The endpoint is relevant to the stated study aim because it measures a participant-reported aspect of life with psoriasis, rather than only a clinician-rated skin assessment. The registry record describes a Full Analysis Set of all randomized participants and a subpopulation with baseline s-PGA≥3. It does not report how many participants achieved the threshold, the group-specific percentages, or the 95% confidence intervals. Without those results and the corresponding denominators, the endpoint’s observed magnitude and precision cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the question the study was designed to address: whether participants receiving deucravacitinib achieved a DLQI score of 0 or 1 at Week 16, compared with participants in a placebo-controlled group. It does not report the outcome percentages or confidence intervals for that endpoint. The posted information therefore does not show the size, direction, or precision of the primary comparison. No conclusion about the endpoint’s observed between-group difference can be drawn from the record details.
The endpoint is binary at the participant level: each participant either meets the DLQI threshold or does not. In general, the percentage for a group depends on both the number meeting the threshold and the number included in that group’s analysis. The registry record does not give those primary-endpoint counts or denominators. Enrollment of 180 is not a substitute for an endpoint denominator; participants may not all contribute to every outcome, and the analysis population may be defined differently from total enrollment. The actual handling of such cases is not reported in the registry record.
The endpoint description names both all randomized participants and a subpopulation with baseline s-PGA≥3. These populations address different questions. In general, a result for a baseline-defined subgroup applies to that subgroup and should not automatically be extended to all randomized participants. The record details do not include results for either population, nor do they explain whether the subpopulation analysis was planned as confirmatory or exploratory.
The record lists a 95% confidence interval as the dispersion measure for the primary outcome. In general, a confidence interval communicates uncertainty around an estimated quantity; a narrower interval indicates greater precision under the method used. The interval itself, its bounds, and the method for calculating it are not reported in the registry record. A confidence interval would not, on its own, establish clinical importance or remove uncertainty from design and measurement choices.
Safety counts are available separately. During the placebo-controlled groupings, the record lists serious adverse events in 3 of 119 participants in the deucravacitinib group and 1 of 59 participants in the placebo group. For the active-treatment groupings, it lists 5 of 103 in the deucravacitinib-deucravacitinib group and 3 of 49 in the placebo-deucravacitinib group. These are descriptive counts within the listed groupings, not the missing primary efficacy result. The labels and time periods differ, so they should not be combined into an unqualified comparison. The record does not provide enough detail to explain overlap, follow-up, attribution, or the statistical handling of safety events.
Overall, the available details describe a completed randomized study and its intended quality-of-life endpoint, alongside selected safety counts. They do not provide the primary endpoint estimates needed to evaluate the treatment comparison statistically. The absence of those estimates in this record is not evidence that the endpoint had no effect; it means the result is not reported in the registry record.
9. Statistical Methods Explained
The posted study description includes a primary endpoint expressed as a percentage and identifies a 95% confidence interval as the dispersion measure. It also names randomized, double-blind, placebo-controlled, parallel design features. However, it does not report a full statistical analysis plan, the endpoint results, or the calculation method for the confidence interval. The explanations below describe general statistical concepts and do not imply that a particular method was used in this trial unless the registry record says so.
What does a percentage endpoint represent?
For a binary endpoint, each participant is classified according to whether they meet the stated criterion. Here, the criterion is achieving a DLQI score of 0 or 1 at Week 16. In general, the group percentage is the number of participants who meet the criterion divided by the number included in the relevant analysis, expressed as a percentage. The numerator and denominator are both needed to interpret the percentage. The registry record does not report the primary endpoint counts or percentages, so they cannot be described.
A percentage gives an intuitive summary of how common the outcome was in a group, but it can conceal variation in the underlying scores. Participants with a DLQI score of 0 and participants with a score of 1 both meet the endpoint, although their scores differ. Participants just outside the threshold are classified with participants farther from it. In general, analyses of a threshold outcome answer a different question from analyses of average score change or the full score distribution.
How should the confidence interval be read?
A confidence interval is a range intended to communicate uncertainty around an estimate under a specified statistical procedure. In general, the estimate is more informative when considered alongside its interval: a wide interval indicates limited precision, while a narrow interval indicates greater precision. The registered endpoint specifies a 95% confidence interval, but the interval bounds and method are not reported in the registry record. The confidence level does not mean that a particular treatment effect is known with certainty, and it does not measure whether an effect is important to participants.
For a treatment comparison, readers would usually need the group-specific percentages and a clearly defined contrast, such as a difference between groups, together with its uncertainty. Those values are not reported. It is therefore not possible to assess the estimated magnitude or precision of a primary comparison from the available record details. Nor is a statistical significance conclusion available from the endpoint description alone.
What does randomization contribute?
In general, random assignment aims to make treatment groups comparable at the start of a study, including with respect to characteristics that may not have been measured. It supports a causal interpretation when the trial is conducted and analyzed appropriately, but randomization does not ensure perfect balance in every realized sample. Double masking can reduce the influence of treatment knowledge on participant reports or study assessments. The record identifies randomization and double masking, but does not report the operational details, such as who was masked or how the allocation sequence was generated and concealed.
The parallel design label indicates groups are compared in parallel rather than describing a crossover. Still, the safety group labels include placebo-controlled and active-treatment groupings, including placebo followed by deucravacitinib. The exact sequence and the analysis populations for these periods are not reported in the registry record. This matters because the period used for a comparison determines which treatment exposure and follow-up are being summarized.
What do the planning illustrations mean?
The sample-size section presents planning illustrations based on a fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning scenarios, not the trial’s own design justification and not observed power. In general, a planning calculation asks how many participants per arm would be needed under stated assumptions to detect a specified effect with a chosen power. The illustrated assumptions do not establish that the actual trial used those assumptions. The sample-size justification in the protocol is not reported in the registry record.
Planning illustrations that use an observed effect are sensitive to the estimate chosen: an effect estimated imprecisely may not represent the effect that would be seen in a new study. The illustrations should therefore be read as conditional scenarios rather than as evidence that the study had adequate or inadequate power. The record does not report the trial’s planned power, target effect, or justification for its enrollment.
What analysis details remain unclear?
The registry record lists seven analyses and ten outcome measures, but does not describe the statistical model or test used for the primary endpoint. It does not report whether the primary comparison was adjusted for baseline factors, how the confidence interval was constructed, how missing Week 16 data were handled, or how participants who changed treatment were analyzed. These details can affect the estimate and its uncertainty. They should not be inferred from the endpoint format or from the fact that the study was randomized.
General statistical practice distinguishes an analysis population from the set of all participants enrolled. The record names the Full Analysis Set as all randomized participants and identifies a baseline s-PGA≥3 subpopulation, but does not provide the analysis-specific denominators or rules for inclusion. As a result, the available description supports an explanation of the endpoint and design labels, but not a reconstruction of the trial’s complete statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary DLQI threshold outcome and secondary outcomes covering DLQI response, itch, physician assessment, and safety. It also reports ten outcome measures and seven analyses. When a study examines multiple outcomes or analyses, general statistical concern about multiplicity is that the chance of at least one apparently notable result can increase if many comparisons are considered. How a study addresses this may depend on which outcomes are confirmatory, the order of testing, and any adjustment or interpretation plan. A multiplicity strategy is not reported in the registry record.
The record does not identify a formal hierarchy among the listed outcomes or explain how the seven analyses relate to the ten outcome measures. It also does not report whether subgroup analyses, such as the population with baseline s-PGA≥3, were included in a testing strategy. Without those details, readers cannot determine which analyses were intended to support confirmatory claims or whether any adjustment was used. This is a limitation in interpreting any set of results, not evidence that a particular adjustment was or was not applied.
Missing-data handling is also not reported in the registry record. In general, missing Week 16 DLQI values can affect a percentage endpoint if participants with unavailable values are excluded, counted as not meeting the threshold, or handled using another method. These choices may change the analysis denominator and the estimate. The endpoint description’s Full Analysis Set label does not reveal the missing-data rule. The number of participants with missing endpoint data, reasons for missingness, and any sensitivity analyses are not reported.
The record identifies all randomized participants as the Full Analysis Set and also describes a subpopulation with baseline s-PGA≥3. It does not provide group-specific numbers analyzed, departures from the randomized assignment, or a detailed analysis-population definition for each result. The approach to treatment changes and post-randomization events is not reported. These gaps limit assessment of how closely the endpoint analyses preserved the randomized comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo Controlled - Deucravacitinib | 3 | 119 | 2.5% |
| Placebo Controlled - Placebo | 1 | 59 | 1.7% |
| Active Treatment - Deucravacitinib - Deucravacitinib | 5 | 103 | 4.9% |
| Active Treatment - Placebo - Deucravacitinib | 3 | 49 | 6.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo Controlled - Deucravacitinib | 1 of 119 |
| Placebo Controlled - Placebo | 0 of 59 |
| Active Treatment - Deucravacitinib - Deucravacitinib | 1 of 103 |
| Active Treatment - Placebo - Deucravacitinib | 0 of 49 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo Controlled - Deucravacitinib | 32 of 119 |
| Placebo Controlled - Placebo | 13 of 59 |
| Active Treatment - Deucravacitinib - Deucravacitinib | 26 of 103 |
| Active Treatment - Placebo - Deucravacitinib | 10 of 49 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo Controlled - Deucravacitinib | Placebo Controlled - Placebo | Active Treatment - Deucravacitinib - Deucravacitinib | Active Treatment - Placebo - Deucravacitinib |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 119 | 0 of 59 | 2 of 103 | 1 of 49 |
| Acute coronary syndrome | Cardiac disorders | 0 of 119 | 0 of 59 | 1 of 103 | 0 of 49 |
| Angina pectoris | Cardiac disorders | 0 of 119 | 1 of 59 | 0 of 103 | 0 of 49 |
| Cardiac failure congestive | Cardiac disorders | 0 of 119 | 0 of 59 | 1 of 103 | 0 of 49 |
| Vertigo positional | Ear and labyrinth disorders | 1 of 119 | 0 of 59 | 0 of 103 | 0 of 49 |
| Chest pain | General disorders | 0 of 119 | 0 of 59 | 1 of 103 | 0 of 49 |
| Death | General disorders | 1 of 119 | 0 of 59 | 0 of 103 | 0 of 49 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 119 | 0 of 59 | 0 of 103 | 1 of 49 |
| Postoperative wound infection | Infections and infestations | 0 of 119 | 0 of 59 | 0 of 103 | 1 of 49 |
| Pyelonephritis | Infections and infestations | 1 of 119 | 0 of 59 | 0 of 103 | 0 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo Controlled - Deucravacitinib | Placebo Controlled - Placebo | Active Treatment - Deucravacitinib - Deucravacitinib | Active Treatment - Placebo - Deucravacitinib |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | 7 of 119 | 2 of 59 | 10 of 103 | 2 of 49 |
| Nasopharyngitis | Infections and infestations | 8 of 119 | 2 of 59 | 4 of 103 | 2 of 49 |
| Upper respiratory tract infection | Infections and infestations | 4 of 119 | 3 of 59 | 8 of 103 | 1 of 49 |
| Acne | Skin and subcutaneous tissue disorders | 9 of 119 | 0 of 59 | 3 of 103 | 2 of 49 |
| Headache | Nervous system disorders | 2 of 119 | 3 of 59 | 2 of 103 | 1 of 49 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 119 | 1 of 59 | 3 of 103 | 3 of 49 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 1 of 119 | 3 of 59 | 3 of 103 | 0 of 49 |
| Sinusitis | Infections and infestations | 6 of 119 | 0 of 59 | 0 of 103 | 0 of 49 |
Serious events with the highest arm-level rate: cholelithiasis (2.0%), pneumonia (2.0%), postoperative wound infection (2.0%), angina pectoris (1.7%), acute coronary syndrome (1.0%).
The registry record presents serious adverse event counts in four labelled groupings. In the placebo-controlled grouping, 3 of 119 participants in the deucravacitinib group and 1 of 59 in the placebo group had a serious adverse event. In the active-treatment grouping, 5 of 103 participants in the deucravacitinib-deucravacitinib group and 3 of 49 in the placebo-deucravacitinib group had a serious adverse event. The record also lists one death in each of the deucravacitinib and deucravacitinib-deucravacitinib groups, and no deaths in the other two listed groups.
These counts should be read with their group labels and denominators. The placebo-controlled and active-treatment groupings refer to differently labelled periods or treatment sequences; the registry entries do not explain their precise timing or whether the participants overlap. The counts should therefore not be combined or treated as a single comparison without further information. The record does not report event attribution, follow-up duration for each grouping, or a statistical comparison of these counts.
In general, a serious adverse event count is not the same as a count of all adverse events, and a count alone does not establish causation. The record separately lists frequent serious-event terms with percentages, including Cholelithiasis and Pneumonia at 2.0%, and Postoperative wound infection at 2.0%. Those term-level percentages do not replace the group-level counts or explain how events were classified. The figures are descriptive safety information, not a basis for treatment advice.
12. What the Result Does, and Does Not, Mean
The record shows that this completed Phase 4 study was designed to evaluate quality of life in participants with plaque psoriasis in a community setting. Its primary endpoint was the percentage achieving a DLQI score of 0 or 1 at Week 16. It also lists secondary measures involving DLQI response, itch, physician assessment, adverse events, laboratory findings, and vital signs. These details establish the questions and outcomes recorded for the study; they do not establish what the primary result was.
The primary endpoint percentages, confidence interval bounds, and group comparison are not reported in the registry record. Consequently, the posted details do not show whether the groups differed, in which direction any difference went, how large it was, or how precisely it was estimated. This absence should not be interpreted as a finding of no difference. It means that the relevant efficacy result is not reported in the registry record.
Even when available, a threshold-based quality-of-life result would describe the proportion meeting a particular score criterion, rather than every aspect of participants’ experience. The DLQI covers several areas of life during the last week, and the endpoint groups participants according to a total score of 0 or 1. In general, a single percentage does not describe the full distribution of scores or the magnitude of changes among people who do not meet the threshold.
The safety information offers counts for serious adverse events and deaths in labelled groupings. Those counts are useful descriptive context, but the group labels include different treatment sequences and the record details do not explain the periods or any overlap. They cannot substitute for the missing primary endpoint result, and they do not establish whether an event was caused by a treatment.
The study’s randomization and masking are features intended to support a fair treatment comparison, but assessment of the evidence also requires the endpoint estimates, uncertainty, analysis populations, missing-data approach, and analysis plan. Several of these details are not reported in the registry record. The available information therefore supports a clear description of the study’s question and selected safety observations, while leaving the primary statistical result and its interpretation unresolved.
13. Why This Trial Matters Statistically
This study raises a useful statistical question about how to summarize a participant-reported quality-of-life outcome. Its primary endpoint is not a change in the average DLQI score, but the percentage of participants who reach a specified low-score threshold at Week 16. These summaries answer different questions. A threshold percentage can be direct to communicate, while a score-change analysis can retain information about changes across the scale. Neither form alone captures every dimension of quality of life.
The community setting is part of the study’s stated purpose. In general, setting can matter when considering how closely the study population and conduct reflect the context in which a question is being asked. But the registry entries do not provide enough information about sites, eligibility criteria, or participant characteristics to judge representativeness. The setting should be understood as a stated feature, not as proof that the results apply to every community population.
The study also highlights why endpoint definitions and analysis populations need to be read together. The record names a Full Analysis Set of all randomized participants and a subpopulation with baseline s-PGA≥3. A percentage is only interpretable when its population and denominator are clear. Since the result counts and denominators are not reported, the primary endpoint cannot be evaluated quantitatively from the available details.
Finally, the listed safety groupings show why time period and treatment sequence matter when reading event counts. The record distinguishes placebo-controlled and active-treatment groupings, but does not explain their relationship in enough detail to combine or compare them confidently. Statistical interpretation depends not only on numerical summaries, but also on knowing which participants, exposures, and follow-up periods those summaries represent. This page therefore illustrates both the value of a clearly defined endpoint and the limits of interpretation when the result and analysis details are unavailable.
14. 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 main limitation for interpreting this trial from the registry record is that the primary endpoint result is not reported in the available details. The group-specific percentages, confidence interval bounds, and primary between-group estimate are absent. Without them, readers cannot assess the magnitude, direction, or precision of the quality-of-life comparison.
The endpoint description names both all randomized participants and a subpopulation with baseline s-PGA≥3, but the corresponding endpoint denominators and results are not reported. The record also does not explain which population was used for each analysis or how participants with missing Week 16 DLQI data were handled. These omissions prevent assessment of whether the analyzed population and missing-data approach could affect the reported estimate.
Several design and analysis details are not reported in the registry record, including the treatment dose and schedule, timing of the placebo-to-deucravacitinib sequence, allocation ratio, site count, statistical model, confidence interval method, and protocol sample-size justification. The record lists seven analyses and ten outcome measures but does not describe any multiplicity strategy or analysis hierarchy. These gaps limit reconstruction of the planned analysis and interpretation of any collection of outcomes.
Safety information is available as counts for differently labelled treatment groupings, but the relationship between those groups and their follow-up periods is not explained. The counts cannot be treated as directly comparable without those details. In addition, the registry entries do not provide participant characteristics or site information with which to assess how closely the study population represents other settings. These are limitations of the information available in the record, rather than conclusions about the conduct or findings of the full study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting — NCT05701995.
- Registry record last updated 2026-06-03; status last verified 2026-05.
- Results first posted 2025-09-10.
- 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.
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18. Record Summary
The registry record describes a completed Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study of deucravacitinib in participants with plaque psoriasis in a community setting. Enrollment is listed as 180. The recorded study start date is 2023-01-31, and the primary completion date is 2024-08-23.
The primary endpoint is the percentage achieving a DLQI score of 0 or 1 at Week 16. The record describes a Full Analysis Set of all randomized participants and a subpopulation with baseline s-PGA≥3. It also lists secondary quality-of-life, itch, physician-assessment, and safety outcomes. Primary endpoint estimates and confidence interval bounds are not reported in the registry record. Serious adverse event counts are listed for placebo-controlled and active-treatment groupings, but the sequence and period details needed to interpret them fully are not reported.