Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01172938 PALACE-1 | Psoriasis | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 Baseline and Week 16 | Apremilast 20 mg | 30.4 percentage of participants |
| Apremilast 30 mg | 38.1 percentage of participants | |||
| Placebo | 19.0 percentage of participants | |||
| NCT01194219 ESTEEM 1 | — | Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline Baseline to Week 16 | Placebo (PBO) | 5.3 percentage of participants |
| Placebo/Apremilast | 33.1 percentage of participants | |||
| NCT01212757 PALACE2 | Psoriasis | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 Baseline and Week 16 | Apremilast 20 mg | 37.4 percentage of participants |
| Apremilast 30 mg | 32.1 percentage of participants | |||
| Placebo | 18.9 percentage of participants | |||
| NCT01212770 PALACE 3 | Psoriasis | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 Baseline and Week 16 | Apremilast 20 mg | 28.4 percentage of participants |
| Apremilast 30 mg | 40.7 percentage of participants | |||
| Placebo | 18.3 percentage of participants | |||
| NCT01232283 ESTEEM 2 | — | Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline Baseline to Week 16 | Apremilast | 28.8 percentage of participants |
| Placebo | 5.8 percentage of participants | |||
| NCT01307423 PALACE4 | Psoriasis | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 Baseline and Week 16 | Apremilast 20mg | 28.0 percentage of participants |
| Apremilast 30mg | 30.7 percentage of participants | |||
| Placebo | 15.9 percentage of participants | |||
| NCT01583374 POSTURE | Spondylitis, Ankylosing | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 Baseline and Week 16 | Apremilast 20 mg | 35.0 Percentage of Participants |
| Apremilast 30 mg | 32.5 Percentage of Participants | |||
| Placebo | 36.6 Percentage of Participants | |||
| NCT01690299 | Psoriasis | Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline Baseline to Week 16 | Apremilast Plus Placebo Injection | 39.8 Percentage of participants |
| Placebo | 11.9 Percentage of participants | |||
| NCT01925768 | Arthritis, Psoriatic | Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16 Baseline and Week 16 | Apremilast (APR) 30 mg | 38.2 percentage of participants |
| Placebo (PBO) | 20.2 percentage of participants | |||
| NCT02307513 | Behcet Syndrome | Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period. | Apremilast 30 mg BID | 129.54 Ulcers*days (±15.943 Standard Error) |
| Placebo | 222.14 Ulcers*days (±15.886 Standard Error) | |||
| NCT03123471 STYLE | Psoriasis | Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline Baseline to Week 16 | Apremilast | 43.3 Percentage of Participants |
| Placebo/Apremilast | 13.7 Percentage of Participants | |||
| NCT03611751 POETYK-PSO-2 | Psoriasis | 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 Placebo at Week 16 (PASI 75) Baseline and Week 16 | BMS-986165 | 271 Participants |
| Placebo | 24 Participants | |||
| NCT03611751 POETYK-PSO-2 | Psoriasis | The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) Week 16 | BMS-986165 | 253 Participants |
| Placebo | 22 Participants | |||
| NCT03624127 POETYK-PSO-1 | Psoriasis | 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 Placebo at Week 16 (PASI 75) Baseline and Week 16 | BMS-986165 | 194 Participants |
| Placebo | 21 Participants | |||
| NCT03624127 POETYK-PSO-1 | Psoriasis | The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) Week 16 | BMS-986165 | 178 Participants |
| Placebo | 12 Participants | |||
| NCT03701763 | Psoriasis | Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 Baseline to Week 16 | Apremilast | 33.1 percentage of participants |
| Placebo | 11.5 percentage of participants | |||
| NCT03721172 ADVANCE | Psoriasis | Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase Baseline and Week 16 of the placebo-controlled phase | Placebo-controlled Phase: Apremilast 30 mg | 21.6 Percentage of participants |
| Placebo-controlled Phase: Placebo | 4.1 Percentage of participants | |||
| NCT03777436 DISCREET | Psoriasis | Percentage of Participants With a Modified sPGA-G Response at Week 16 Baseline and Week 16 of the Placebo-controlled Phase | Placebo-controlled Phase: Apremilast 30 mg | 39.6 Percentage of participants |
| Placebo-controlled Phase: Placebo | 19.5 Percentage of participants | |||
| NCT03930186 | — | Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 Week 16 | Apremilast | 43.7 percentage of participants |
| NCT04590586 COMMUNITY | COVID-19 | Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29 Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29 | Apremilast + Standard of Care | 14.0 days |
| Apremilast Placebo Control | 14.0 days | |||
| NCT04590586 COMMUNITY | COVID-19 | Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29 Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29 | Lanadelumab + Standard of Care | 10.0 days |
| Lanadelumab Placebo Control | 15.5 days | |||
| NCT04590586 COMMUNITY | COVID-19 | Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29 Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29 | Zilucoplan + Standard of Care | 14.0 days |
| Zilucoplan Placebo Control | 15.0 days | |||
| NCT04908189 | Arthritis, Psoriatic | Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 Week 16 | Deucravacitinib | 169 Participants |
| Placebo | 123 Participants | |||
| NCT05174065 | Psoriasis | Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score (PPPASI-50) at Week 16 Baseline and Week 16 | Placebo-controlled Period: Apremilast | 67.8 percentage of participants |
| Placebo-controlled Period: Placebo | 35.3 percentage of participants |