Comparison · NCT03611751-a7650ee8
BMS-986165 vs Apremilast: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. BMS-986165 vs Apremilast: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75). Trial comparisons, record NCT03611751-a7650ee8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03611751-a7650ee8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.53 | 0.487 | 0.573 | wilson | |
| Risk in group 2 | 0.398 | 0.339 | 0.459 | wilson | |
| Risk difference, group 1 minus group 2 | 0.133 | 0.0576 | 0.205 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 1.12 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 1.26 | 2.32 | log | |
| Number needed to treat, for one more participant with the outcome on BMS-986165 than on Apremilast | 7.54 | 4.88 | 17.3 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BMS-986165 | Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).~Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24. | 271 | 511 | OG000 |
| Group 2 | Apremilast | Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)~* 10 mg used for titration Day 1 through Day 3 morning dose~* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.~* 30 mg from Day 5 evening dose onwards.~Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24. | 101 | 254 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
- Description
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.~The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).~Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
- Time frame
- Baseline and Week 16
- Population
- All randomized participants in the BMS-986165 and Apremilast arms.
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
- NCT number
- NCT03611751
- Phases
- PHASE3
- Conditions
- Psoriasis
- Interventions
- BMS-986165, Placebo, Apremilast
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2022-12-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03611751?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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