Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ustekinumab approximately/kg · 1 trial · 1 indication
Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
| Arm | Type | Description |
|---|---|---|
| Group 1: Ustekinumab (IV re-induction) | EXPERIMENTAL | Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
| Group 2: Ustekinumab (Continuous q8w SC maintenance) | ACTIVE_COMPARATOR | Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
| Name | Type | Description |
|---|---|---|
| Ustekinumab approximately 6 mg/kg (IV) | DRUG | Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0. |
| Placebo (SC) | DRUG | Participants will receive SC injection of placebo at Week 0. |
| Placebo (IV) | DRUG | Participants will receive IV infusion of placebo at Week 0. |
| Ustekinumab 90 mg (SC) Group 1 | DRUG | Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16. |
| Ustekinumab 90 mg (SC) Group 2 | DRUG | Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16. |
Inclusion criteria: * A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekin...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE3 | Duvakitug, Brivekimig |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Ustekinumab approximately/kg refers to a weight-based intravenous dosing regimen of ustekinumab studied in Crohn disease. It was evaluated as re-induction therapy in adults with moderately to severely active Crohn disease. The regimen is expressed as approximately 6 mg/kg given intravenously.
Ustekinumab approximately/kg targets the p40 subunit shared by the cytokines IL-12 and IL-23, binding IL12B, IL12A and IL23A. It acts as an inhibitor of these pathways. By blocking this subunit, the drug interferes with inflammatory signaling implicated in Crohn disease.
Ustekinumab approximately/kg is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 study of this weight-based intravenous regimen in Crohn disease.
Ustekinumab approximately/kg has been studied in Phase 3. The single registered trial, NCT03782376, is completed. It is an investigational weight-based intravenous regimen and is not described as approved for this use.
Ustekinumab approximately/kg was evaluated in one Phase 3 trial, NCT03782376, titled A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease. The trial enrolled 215 adults across the United States, Europe and South Korea and is completed.