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 |
|---|---|---|---|---|
| NCT02672852 | Psoriasis | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 Baseline, Week 16 | Placebo (Part A1) | 2.0 percentage of participants |
| Risankizumab (Part A1) | 73.2 percentage of participants | |||
| NCT02672852 | Psoriasis | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 Week 52 | Risankizumab/Placebo (Part B; Rerandomized Responders) | 61.3 percentage of participants |
| Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 87.4 percentage of participants | |||
| NCT02672852 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 Week 16 | Placebo (Part A1) | 7.0 percentage of participants |
| Risankizumab (Part A1) | 83.5 percentage of participants | |||
| NCT02684357 | Psoriasis | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) Week 16 | Placebo (Part A) | 2.0 percentage of participants |
| Risankizumab (Part A) | 74.8 percentage of participants | |||
| NCT02684357 | Psoriasis | Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) Week 16 | Placebo (Part A) | 5.1 percentage of participants |
| Risankizumab (Part A) | 83.7 percentage of participants | |||
| NCT02684370 | Psoriasis | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) Week 16 | Placebo (Part A) | 4.9 percentage of participants |
| Risankizumab (Part A) | 75.3 percentage of participants | |||
| NCT02684370 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) Week 16 | Placebo (Part A) | 7.8 percentage of participants |
| Risankizumab (Part A) | 87.8 percentage of participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) Week 16 | Adalimumab (Part A) | 47.4 percentage of participants |
| Risankizumab (Part A) | 72.4 percentage of participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) Week 16 | Adalimumab (Part A) | 60.2 percentage of participants |
| Risankizumab (Part A) | 83.7 percentage of participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) Week 44 | Adalimumab/Rerandomized to Adalimumab (Part B) | 21.4 percentage of participants |
| Adalimumab/Rerandomized to Risankizumab (Part B) | 66.0 percentage of participants | |||
| NCT03022045 | Psoriasis | Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 Week 16 | EP Risankizumab 150 mg | 100 percentage of participants |
| EP Risankizumab 75 mg | 100 percentage of participants | |||
| NCT03022045 | Psoriasis | Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 Week 16 | GPP Risankizumab 150 mg | 100 percentage of participants |
| GPP Risankizumab 75 mg | 100 percentage of participants | |||
| NCT03047395 LIMMITLESS | Psoriasis | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events Median follow-up time of 1905 days | Risankizumab 150 mg | 435 Participants |
| Risankizumab 150 mg | 1215 Participants | |||
| NCT03104413 | Crohn Disease | Global Outside of US: Percentage of Participants With Clinical Remission Week 12 | Placebo (Induction Period 1) | 11.2 percentage of participants |
| Placebo (Induction Period 1) | 8 percentage of participants | |||
| Risankizumab 1200mg (Induction Period 1) | 34.2 percentage of participants | |||
| Risankizumab 1200mg (Induction Period 1) | 18.3 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 28.8 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 17.3 percentage of participants | |||
| NCT03104413 | Crohn Disease | Global Outside of US: Percentage of Participants With Endoscopic Response Week 12 | Placebo (Induction Period 1) | 19.3 percentage of participants |
| Risankizumab 1200mg (Induction Period 1) | 39.8 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 34.6 percentage of participants | |||
| NCT03104413 | Crohn Disease | US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Week 12 | Placebo (Induction Period 1) | 19.8 percentage of participants |
| Placebo (Induction Period 1) | 11.2 percentage of participants | |||
| Risankizumab 1200mg (Induction Period 1) | 40.3 percentage of participants | |||
| Risankizumab 1200mg (Induction Period 1) | 19.4 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 42.0 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 20.9 percentage of participants | |||
| NCT03104413 | Crohn Disease | US Specific: Percentage of Participants With Endoscopic Response Week 12 | Placebo (Induction Period 1) | 11.2 percentage of participants |
| Risankizumab 1200mg (Induction Period 1) | 34.2 percentage of participants | |||
| Risankizumab 600mg (Induction Period 1) | 28.8 percentage of participants | |||
| NCT03105128 | Crohn Disease | Global Outside of US: Percentage of Participants With Clinical Remission Week 12 | Placebo (Period 1) | 9.1 percentage of participants |
| Placebo (Period 1) | 21.7 percentage of participants | |||
| Risankizumab 1200mg (Period 1) | 41.0 percentage of participants | |||
| Risankizumab 1200mg (Period 1) | 21.2 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 43.5 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 21.0 percentage of participants | |||
| NCT03105128 | Crohn Disease | Global Outside of US: Percentage of Participants With Endoscopic Response Week 12 | Placebo (Period 1) | 12.0 percentage of participants |
| Risankizumab 1200mg (Period 1) | 32.1 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 40.3 percentage of participants | |||
| NCT03105128 | Crohn Disease | US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Week 12 | Placebo (Period 1) | 24.6 percentage of participants |
| Placebo (Period 1) | 10.3 percentage of participants | |||
| Risankizumab 1200mg (Period 1) | 41.6 percentage of participants | |||
| Risankizumab 1200mg (Period 1) | 18.9 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 45.2 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 18.4 percentage of participants | |||
| NCT03105128 | Crohn Disease | US Specific: Percentage of Participants With Endoscopic Response Week 12 | Placebo (Period 1) | 12.0 percentage of participants |
| Risankizumab 1200mg (Period 1) | 32.1 percentage of participants | |||
| Risankizumab 600mg (Period 1) | 40.3 percentage of participants | |||
| NCT03255382 | Psoriasis | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 Week 24 | Fumaderm | 10.0 percentage of participants |
| Risankizumab | 83.3 percentage of participants | |||
| NCT03398148 | Colitis, Ulcerative | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score Week 12 | Substudy 1, Induction Period 1: Double-blind Placebo IV | 1 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 6 Participants | |||
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | 6 Participants | |||
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 7 Participants | |||
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | 42 Participants | |||
| NCT03398148 | Colitis, Ulcerative | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score Week 12 | Substudy 2, Induction Period 1: Double-blind Placebo IV | 6.2 percentage of participants |
| Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV | 20.3 percentage of participants | |||
| NCT03478787 | Psoriasis | Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 Week 16 | Risankizumab | 73.8 percentage of participants |
| Secukinumab | 65.6 percentage of participants | |||
| NCT03478787 | Psoriasis | Percentage of Participants With a PASI 90 at Week 52 Week 52 | Risankizumab | 86.6 percentage of participants |
| Secukinumab | 57.1 percentage of participants | |||
| NCT03671148 KEEPsAKE2 | Arthritis, Psoriatic | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 Baseline and Week 24 | Placebo | 26.5 percentage of participants |
| Risankizumab | 51.3 percentage of participants | |||
| NCT03675308 KEEPsAKE 1 | Arthritis, Psoriatic | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 Baseline and Week 24 | Placebo | 33.5 percentage of participants |
| Risankizumab | 57.3 percentage of participants | |||
| NCT03875482 | Psoriasis | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 At Week 16 | Placebo | 3.8 percentage of participants |
| Risankizumab | 62.9 percentage of participants | |||
| NCT03875482 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 At Week 16 | Placebo | 9.6 percentage of participants |
| Risankizumab | 78.1 percentage of participants | |||
| NCT03875508 | Psoriasis | Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Day 1, Week 4, Week 16, Week 28 | Risankizumab | 8.82 units on a scale (±1.415 Standard Deviation) |
| Risankizumab | 9.458 units on a scale (±1.0500 Standard Deviation) | |||
| Risankizumab | 9.725 units on a scale (±0.8911 Standard Deviation) | |||
| Risankizumab | 9.39 units on a scale (±0.971 Standard Deviation) | |||
| Risankizumab | 9.34 units on a scale (±1.614 Standard Deviation) | |||
| Risankizumab | 8.358 units on a scale (±2.3613 Standard Deviation) | |||
| Risankizumab | 8.556 units on a scale (±2.0646 Standard Deviation) | |||
| Risankizumab | 9.056 units on a scale (±1.0321 Standard Deviation) | |||
| Risankizumab | 9.817 units on a scale (±0.4469 Standard Deviation) | |||
| Risankizumab | 9.53 units on a scale (±1.261 Standard Deviation) | |||
| Risankizumab | 8.478 units on a scale (±2.0024 Standard Deviation) | |||
| Risankizumab | 8.112 units on a scale (±2.6313 Standard Deviation) | |||
| Risankizumab | 9.096 units on a scale (±1.1572 Standard Deviation) | |||
| Risankizumab | 9.700 units on a scale (±0.5710 Standard Deviation) | |||
| Risankizumab | 8.84 units on a scale (±1.240 Standard Deviation) | |||
| Risankizumab | 9.16 units on a scale (±1.964 Standard Deviation) | |||
| Risankizumab | 8.750 units on a scale (±1.8483 Standard Deviation) | |||
| Risankizumab | 8.367 units on a scale (±2.5921 Standard Deviation) | |||
| Risankizumab | 9.229 units on a scale (±1.1517 Standard Deviation) | |||
| Risankizumab | 9.763 units on a scale (±0.4576 Standard Deviation) | |||
| Risankizumab | 8.93 units on a scale (±1.394 Standard Deviation) | |||
| Risankizumab | 9.28 units on a scale (±1.678 Standard Deviation) | |||
| Risankizumab | 8.675 units on a scale (±2.0661 Standard Deviation) | |||
| Risankizumab | 8.795 units on a scale (±2.3034 Standard Deviation) | |||
| NCT03875508 | Psoriasis | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 At Week 16 | Risankizumab | 46.3 percentage of participants |
| NCT03875508 | Psoriasis | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16 At Week 16 | Risankizumab | 84.3 percentage of participants |
| NCT03875508 | Psoriasis | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 At Week 16 | Risankizumab | 66.7 percentage of participants |
| NCT03875508 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 At Week 16 | Risankizumab | 81.5 percentage of participants |
| NCT03875508 | Psoriasis | Percentage of Participants Who Had No Potential Hazards as Measured by an Observer Day 1 and Week 28 | Risankizumab | 100 percentage of participants |
| Risankizumab | 100 percentage of participants | |||
| NCT03875508 | Psoriasis | Percentage of Participants With an Observer Rating of Successful Participant Self-administration Day 1 and Week 28 | Risankizumab | 100 percentage of participants |
| Risankizumab | 100 percentage of participants | |||
| NCT04102007 | — | Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 At Week 16 | Risankizumab | 152 Participants |
| Risankizumab | 140 Participants | |||
| NCT04435600 OptIMMize-1 | Psoriasis | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | Part 1: Risankizumab | 83.3 percentage of participants |
| Part 2 Period A: Risankizumab | 85.2 percentage of participants | |||
| Part 2 Period A: Ustekinumab | 85.7 percentage of participants | |||
| Part 3: Risankizumab | 92.3 percentage of participants | |||
| Part 4: Risankizumab | 86.7 percentage of participants | |||
| NCT04435600 OptIMMize-1 | Psoriasis | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) At Week 16 of initial treatment in each part of the study (Parts 1-4) | Part 1: Risankizumab | 83.3 percentage of participants |
| Part 2 Period A: Risankizumab | 79.6 percentage of participants | |||
| Part 2 Period A: Ustekinumab | 75.0 percentage of participants | |||
| Part 3: Risankizumab | 84.6 percentage of participants | |||
| Part 4: Risankizumab | 90.0 percentage of participants | |||
| NCT04435600 OptIMMize-1 | Psoriasis | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4) | Part 1: Risankizumab | 83.3 percentage of participants |
| Part 2 Period A: Risankizumab | 68.5 percentage of participants | |||
| Part 2 Period A: Ustekinumab | 67.9 percentage of participants | |||
| Part 2 Period C: Risankizumab | 0.0 percentage of participants | |||
| Part 2 Period C: Risankizumab | 62.5 percentage of participants | |||
| Part 3: Risankizumab | 84.6 percentage of participants | |||
| Part 4: Risankizumab | 83.3 percentage of participants | |||
| NCT04713592 IMMprint | Psoriasis | Number of Participants With Treatment-Emergent Adverse Events From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks) | Placebo | 20 Participants |
| Placebo | 0 Participants | |||
| Placebo/Risankizumab | 0 Participants | |||
| Placebo/Risankizumab | 29 Participants | |||
| Risankizumab | 25 Participants | |||
| Risankizumab | 5 Participants | |||
| Risankizumab/Risankizumab | 40 Participants | |||
| Risankizumab/Risankizumab | 5 Participants | |||
| NCT04713592 IMMprint | Psoriasis | Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 Baseline, Week 16 | Placebo | 16.1 percentage of participants |
| Risankizumab | 33.3 percentage of participants |