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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...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| 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 q8w refers to ustekinumab 90 mg administered subcutaneously every 8 weeks as maintenance therapy for adults with moderately to severely active Crohn's disease. It is also studied in colitis and inflammatory bowel disease. The regimen is given to patients aged 18 years and older.
Ustekinumab q8w targets the p40 subunit shared by the cytokines IL-12 and IL-23, binding the IL12B, IL12A, and IL23A subunits. As an inhibitor monoclonal antibody, it blocks these cytokine pathways involved in inflammatory signaling in Crohn's disease.
Ustekinumab q8w is developed by Johnson & Johnson, which trades under the ticker JNJ. The company conducted the Phase 3 IM-UNITI maintenance study evaluating the 90 mg subcutaneous every-8-weeks dosing regimen in Crohn's disease.
Ustekinumab q8w has been evaluated in Phase 3 clinical development. The Phase 3 IM-UNITI trial, NCT01369355, is completed. This maintenance regimen is investigational in the Crohn's disease setting described here.
Ustekinumab q8w was studied in the Phase 3 IM-UNITI trial, NCT01369355, titled A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease. The randomized, double-blind, placebo-controlled trial enrolled 1,282 patients across 27 countries and is completed.