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Ustekinumab q8w · 1 trial · 4 indications
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-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). A decrease in CDAI over time indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| 001 | PLACEBO_COMPARATOR | Participants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w). |
| 002 | EXPERIMENTAL | Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w). |
| 003 | EXPERIMENTAL | Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w). |
| 004 | EXPERIMENTAL | Participants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w. |
| 005 | EXPERIMENTAL | Participants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w. |
| 006 | PLACEBO_COMPARATOR | Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w. |
| Name | Type | Description |
|---|---|---|
| Placebo SC | DRUG | Placebo will be administered subcutaneously. |
| Placebo IV | DRUG | Placebo will be administered as a single Intravenous infusion at week 0. |
| Ustekinumab 90 mg SC q8w | DRUG | Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40. |
| Ustekinumab 130 mg IV | DRUG | Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0. |
| Ustekinumab 90 mg SC q12w | DRUG | Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40. |
Inclusion Criteria: * Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria: * Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002 * Pat...
| 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 q8w is an investigational small molecule being studied for the treatment of moderately to severely active Crohn's Disease. It is administered every 8 weeks as a maintenance therapy. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Ustekinumab q8w 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 safety and efficacy in patients with Crohn's Disease.
Ustekinumab q8w is in Phase 3 clinical development for Crohn's Disease. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug remains under clinical investigation.
Ustekinumab q8w was studied in a Phase 3 clinical trial with the identifier NCT01369355, titled 'A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)'. This randomized, double-blind, placebo-controlled trial enrolled 1,282 participants and has been completed.
Ustekinumab q8w refers to a specific dosing regimen of ustekinumab, administered every 8 weeks. The drug is being evaluated as a maintenance therapy for Crohn's Disease. The Phase 3 trial NCT01369355 assessed this dosing schedule in patients with moderately to severely active disease.