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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Ustekinumab approximately/kg is being studied for the treatment of moderately to severely active Crohn's disease. It is an investigational therapy in Phase 3 clinical development. The drug is being evaluated for its efficacy and safety in patients with this condition.
Ustekinumab approximately/kg is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's potential in treating Crohn's disease.
Ustekinumab approximately/kg is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, with results expected to inform further development decisions.
Ustekinumab approximately/kg has one completed Phase 3 clinical trial registered under NCT03782376. The study evaluated the efficacy and safety of ustekinumab re-induction therapy in participants with moderately to severely active Crohn's disease. The trial enrolled 215 participants across multiple countries.
Ustekinumab approximately/kg is a formulation of ustekinumab, a biologic therapy. The name includes a dosing specification, approximately per kilogram of body weight. It is being studied specifically for Crohn's disease, building on the established use of ustekinumab in inflammatory conditions.