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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...
| 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 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| 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 |