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 |
|---|---|---|---|---|
| NCT00267969 PHOENIX1 | Psoriasis | Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. Week 12 | Placebo | 8 Participants |
| Ustekinumab 45 mg | 171 Participants | |||
| Ustekinumab 90 mg | 170 Participants | |||
| NCT00307437 | Psoriasis | Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 Week 0 to Week 12 | Group I: Placebo | 15 Participants |
| Group II: Ustekinumab 45 mg | 273 Participants | |||
| Group III: Ustekinumab 90 mg | 311 Participants | |||
| NCT00723528 | Psoriasis | Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score Week 12 | Placebo (CP) | 6.5 Percentage of participants |
| Ustekinumab 45 mg (CP) | 59.4 Percentage of participants | |||
| Ustekinumab 90 mg (CP) | 67.7 Percentage of participants | |||
| NCT00747344 | Psoriasis | The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12 Week 12 | Placebo | 3 Participants |
| Ustekinumab 45 mg | 41 Participants | |||
| NCT01008995 | Psoriasis | The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. Baseline (Week 0) to Week 12 | Placebo (CP) | 18 Participants |
| Ustekinumab 45 mg (CP) | 132 Participants | |||
| NCT01009086 | Psoriasis | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. Week 24 | All Ustekinumab Combined | 46.0 Percentage of participants |
| Placebo | 22.8 Percentage of participants | |||
| Ustekinumab 45 mg | 42.4 Percentage of participants | |||
| Ustekinumab 90 mg | 49.5 Percentage of participants | |||
| NCT01077362 | Psoriasis | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. Week 24 | All Ustekinumab Combined | 43.8 Percentage of participants |
| Placebo | 20.2 Percentage of participants | |||
| Ustekinumab 45 mg | 43.7 Percentage of participants | |||
| Ustekinumab 90 mg | 43.8 Percentage of participants | |||
| NCT01090427 | Psoriasis | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 Week 12 | Placebo | 5.4 Percentage of Participants |
| Ustekinumab Half-Standard Dosage | 67.6 Percentage of Participants | |||
| Ustekinumab Standard Dosage | 69.4 Percentage of Participants | |||
| NCT01369329 | Crohn Disease | Number of Participants With Clinical Response at Week 6 Baseline and Week 6 | Placebo | 53 participants |
| Ustekinumab 130 Milligram (mg) | 84 participants | |||
| Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) | 84 participants | |||
| NCT01369342 | Crohn Disease | Number of Participants With Clinical Response at Week 6 Week 6 | Placebo | 60 participants |
| Ustekinumab 130 mg | 108 participants | |||
| Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) | 116 participants | |||
| NCT01369355 | Crohn Disease | Number of Participants With Clinical Remission at Week 44 Week 44 | Placebo Subcutaneously (SC) | 47 participants |
| Ustekinumab 90 mg SC q8w | 68 participants | |||
| Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) | 63 participants | |||
| NCT01550744 PSTELLAR | Psoriasis | The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) | Group 1: Ustekinumab q12w Maintenance Regimen (MR) | 4.5 number of visits (±3.07 95% Confidence Interval) |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | 4.1 number of visits (±2.93 95% Confidence Interval) | |||
| NCT01708603 AMAGINE-2 | Psoriasis | Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 12 Weeks | Brodalumab 140mg | 157 Participants |
| Brodalumab 210mg | 272 Participants | |||
| Placebo | 2 Participants | |||
| Ustekinumab | 65 Participants | |||
| NCT01708603 AMAGINE-2 | Psoriasis | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 12 weeks | 140 mg Brodalumab | 406 Participants |
| 210 mg Brodalumab | 528 Participants | |||
| Placebo | 25 Participants | |||
| Ustekinumab | 210 Participants | |||
| NCT01708603 AMAGINE-2 | Psoriasis | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 12 weeks | 140 mg Brodalumab | 354 Participants |
| 210 mg Brodalumab | 481 Participants | |||
| Placebo | 12 Participants | |||
| Ustekinumab | 183 Participants | |||
| NCT01708629 AMAGINE-3 | Psoriasis | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 12 weeks | 140 mg Brodalumab | 435 Participants |
| 210 mg Brodalumab | 531 Participants | |||
| Placebo | 19 Participants | |||
| Ustekinumab | 217 Participants | |||
| NCT01708629 AMAGINE-3 | Psoriasis | Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo 12 weeks | 140 mg Brodalumab | 377 Participants |
| 210 mg Brodalumab | 497 Participants | |||
| Placebo | 13 Participants | |||
| NCT02074982 | Dermatitis | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 Week 16 | AIN457 300 mg | 79.0 Percentage of Participants |
| Ustekinumab | 57.3 Percentage of Participants | |||
| NCT02203032 NAVIGATE | Psoriasis | Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 Week 28 through Week 40 | Guselkumab (Randomized) | 1.5 visits (±1.57 Standard Deviation) |
| Ustekinumab (Randomized) | 0.7 visits (±1.26 Standard Deviation) | |||
| NCT02407223 | — | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 Week 24 | Placebo | 47.6 Percentage of participants |
| Ustekinumab 45 mg | 55.4 Percentage of participants | |||
| Ustekinumab 90 mg | 49.4 Percentage of participants | |||
| NCT02407236 UNIFI | Colitis, Ulcerative | Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) Week 8 | Induction Study (IS): Placebo Intravenous (IV) | 17 Participants |
| IS: Ustekinumab 130 Milligram (mg) IV | 50 Participants | |||
| IS: Ustekinumab Approximately 6 mg/kg IV | 50 Participants | |||
| NCT02407236 UNIFI | Colitis, Ulcerative | Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) Week 8 | Induction Study (IS): Placebo Intravenous (IV) | 20 Participants |
| IS: Ustekinumab 130 Milligram (mg) IV | 53 Participants | |||
| IS: Ustekinumab Approximately 6 mg/kg IV | 61 Participants | |||
| NCT02407236 UNIFI | Colitis, Ulcerative | Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) Week 44 | Maintenance Study (MS): Placebo Subcutaneous (SC) | 42 Participants |
| MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) | 66 Participants | |||
| MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w) | 77 Participants | |||
| NCT02407236 UNIFI | Colitis, Ulcerative | Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) Week 44 | Maintenance Study (MS): Placebo Subcutaneous (SC) | 43 Participants |
| MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) | 68 Participants | |||
| MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w) | 75 Participants | |||
| NCT02437162 | Axial Spondyloarthritis | Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 Week 24 | Placebo | 28.4 Percentage of participants |
| Ustekinumab 45 Milligram (mg) | 31.0 Percentage of participants | |||
| Ustekinumab 90 mg | 28.1 Percentage of participants | |||
| NCT02438787 | Spondylitis, Ankylosing | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 Week(W) 24 | Placebo | 12.3 Percentage of participants |
| Ustekinumab 45mg | 19.2 Percentage of participants | |||
| Ustekinumab 90mg | 26.9 Percentage of participants | |||
| NCT02561806 IXORA-S | — | Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline Week 12 | Ixekizumab | 72.8 percentage of participants |
| Ustekinumab | 42.2 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 | |||
| NCT02698475 CADMUS Jr | Psoriasis | Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 Week 12 | Ustekinumab Standard Dose (Main Study) | 77.3 percentage of participants |
| NCT02826603 CLARITY | — | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Week 12 | Secukinumab 300mg (2 x 150 mg) | 366 Participants |
| Ustekinumab 2 x 45mg or 90mg | 265 Participants | |||
| NCT02826603 CLARITY | — | Participants With IGA Mod 2011 0 or 1 at Week 12 Week 12 | Secukinumab 300mg (2 x 150 mg) | 397 Participants |
| Ustekinumab 2 x 45mg or 90mg | 306 Participants | |||
| NCT03107793 STARDUST | Crohn Disease | Percentage of Participants With Endoscopic Response at Week 48 Week 48 | Maintenance Period: Routine Care | 29.9 Percentage of Participants (±23.9 95% Confidence Interval) |
| Maintenance Period: Treat to Target | 37.9 Percentage of Participants (±31.4 95% Confidence Interval) | |||
| NCT03370133 BE VIVID | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W (RS) | 85.0 percentage of participants |
| Placebo (RS) | 4.8 percentage of participants | |||
| Ustekinumab (RS) | 49.7 percentage of participants | |||
| NCT03370133 BE VIVID | Psoriasis | Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W (RS) | 84.1 percentage of participants |
| Placebo (RS) | 4.8 percentage of participants | |||
| Ustekinumab (RS) | 53.4 percentage of participants | |||
| NCT03464136 SEAVUE | Crohn Disease | Percentage of Participants With Clinical Remission at Week 52 Week 52 | Adalimumab | 61.0 percentage of participants |
| Ustekinumab | 64.9 percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 Baseline and Week 12 | GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w | -143.7 Units on a scale (±96.58 Standard Deviation) |
| GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w | -139.2 Units on a scale (±100.71 Standard Deviation) | |||
| GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | -159.8 Units on a scale (±110.52 Standard Deviation) | |||
| GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w | -34.4 Units on a scale (±104.85 Standard Deviation) | |||
| NCT03466411 GALAXI | Crohn Disease | Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 Weeks 48 | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 38.4 Percentage of participants |
| GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 39.2 Percentage of participants | |||
| GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 5.3 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 Weeks 48 | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 54.8 Percentage of participants |
| GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 49.0 Percentage of participants | |||
| GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 11.8 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 Weeks 48 | GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 36.0 Percentage of participants |
| GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 33.6 Percentage of participants | |||
| GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 5.6 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 Weeks 48 | GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 48.0 Percentage of participants |
| GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 46.9 Percentage of participants | |||
| GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 12.5 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12 Week 12 | GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) | 47.1 Percentage of participants |
| GALAXI 2 Placebo (From Group 4) | 22.4 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12 Week 12 | GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) | 37.7 Percentage of participants |
| GALAXI 2 Placebo (From Group 4) | 10.5 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12 Week 12 | GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) | 47.1 Percentage of participants |
| GALAXI 3 Placebo (From Group 4) | 15.3 Percentage of participants | |||
| NCT03466411 GALAXI | Crohn Disease | Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12 Week 12 | GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) | 36.2 Percentage of participants |
| GALAXI 3 Placebo (From Group 4) | 13.9 Percentage of participants | |||
| NCT03517722 | Lupus Erythematosus, Systemic | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 Week 52 | Placebo to Ustekinumab | 56.0 percentage of participants |
| Ustekinumab | 43.9 percentage of participants | |||
| NCT03782376 POWER | Crohn Disease | Percentage of Participants With Clinical Response at Week 16 Week 16 | Group 1: Ustekinumab (IV Re-induction) | 49.1 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | 37.4 Percentage of participants | |||
| NCT03926130 VIVID-1 | Crohn Disease | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) Week 12 to Week 52 | Mirikizumab | 45.4 percentage of participants |
| Placebo | 19.6 percentage of participants | |||
| NCT03926130 VIVID-1 | Crohn Disease | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) Week 12 to Week 52 | Mirikizumab | 38.0 percentage of participants |
| Placebo | 9.0 percentage of participants | |||
| NCT03981744 | Dermatomyositis | Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24 Week 24 | Placebo | 61.5 Percentage of participants |
| Ustekinumab | 64.0 Percentage of participants | |||
| NCT04245215 REScUE | Crohn Disease | Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48 week 48 | Ustekinumab q4w | 8 Participants |
| Ustekinumab q8w | 10 Participants | |||
| NCT04305327 EMBRACE 1 | Psoriasis | Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. Baseline to Week 12 | Brodalumab | NA Participants |
| Placebo/Ustekinumab | NA 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 | |||
| NCT04607980 | Psoriasis | PASI Percent Change From Baseline to Week 12 Baseline (Day 1 [Week 0]) and Week 12 | Treatment Group A (ABP 654) | 81.92 Percent Change in PASI score (±19.872 Standard Deviation) |
| Treatment Group B (Ustekinumab) | 81.91 Percent Change in PASI score (±19.611 Standard Deviation) | |||
| NCT04632927 AgAIN | Arthritis, Psoriatic | Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 Baseline, Week 28 | Secukinumab | 32 Participants |
| Ustekinumab | 17 Participants | |||
| NCT04761627 | Psoriasis | Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64 Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose | Post-randomization Continued-use: Ustekinumab RP | 5768.45 hour*mcg/mL (±50.4 Geometric Coefficient of Variation) |
| Post-randomization Switching: Ustekinumab RP and ABP 654 | 5144.40 hour*mcg/mL (±45.3 Geometric Coefficient of Variation) | |||
| NCT04761627 | Psoriasis | Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64 Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose | Post-randomization Continued-use: Ustekinumab RP | 6.31 mcg/mL (±46.8 Geometric Coefficient of Variation) |
| Post-randomization Switching: Ustekinumab RP and ABP 654 | 5.78 mcg/mL (±41.4 Geometric Coefficient of Variation) | |||
| NCT04882072 | Takayasu Arteritis | Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | Double-blind: Placebo | 12.64 Weeks |
| Double-blind: Ustekinumab | 11.14 Weeks | |||
| NCT04967508 | Psoriasis | Percent Change From Baseline in PASI at Week 12 Baseline and Week 12 | SB17 (Proposed Ustekinumab Biosimilar) | 85.7 Percent change (±2.53 Standard Error) |
| Stelara (Ustekinumab) | 86.3 Percent change (±2.41 Standard Error) |