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Group 2 ustekinumab · 2 trials · 4 indications
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| 001 | PLACEBO_COMPARATOR | Group 1: Placebo Form=solution for injection route=intravenous use in a single dose. |
| 002 | EXPERIMENTAL | Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose. |
| 003 | EXPERIMENTAL | Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg). |
| Placebo IV | PLACEBO_COMPARATOR | Group 1: Placebo Form=solution for injection route=intravenous use in a single dose. |
| Ustekinumab 130 milligram (mg) | EXPERIMENTAL | Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose. |
| Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg) | EXPERIMENTAL | Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg). |
| Name | Type | Description |
|---|---|---|
| Group 2 ustekinumab 130 mg | DRUG | Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose. |
| Group 3: ustekinumab approximately 6 mg/kg | DRUG | Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg). |
| Group 1: Placebo | DRUG | Form=solution for injection, route=intravenous use, in a single dose. |
Inclusion Criteria: * Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy * Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of \>= 220 and...
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 |
Group 2 ustekinumab is used for the treatment of moderately to severely active Crohn's disease, a form of inflammatory bowel disease. It was studied in adults, including patients who had failed or were intolerant to tumor necrosis factor antagonist therapy, as well as patients who had not previously received those agents.
Group 2 ustekinumab is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 clinical program evaluating the therapy in Crohn's disease.
Group 2 ustekinumab is in Phase 3 clinical development for Crohn's disease. Both of its registered trials, UNITI-1 and UNITI-2, have been completed, and the program enrolled a total of 1,409 patients across the two studies.
Group 2 ustekinumab was evaluated in two completed Phase 3 trials: NCT01369342, known as UNITI-2, which enrolled 640 patients, and NCT01369329, known as UNITI-1, which enrolled 769 patients. Both were randomized, double-blind, placebo-controlled studies in moderately to severely active Crohn's disease.
Group 2 ustekinumab was studied in two randomized, double-blind, placebo-controlled Phase 3 trials in adults with moderately to severely active Crohn's disease. UNITI-1 enrolled patients who had failed or were intolerant to TNF antagonist therapy, while UNITI-2 enrolled a broader patient population. Both trials are completed.