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CCX282-B · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | Blinded study arm |
| 4 | EXPERIMENTAL | Blinded study arm |
| Name | Type | Description |
|---|---|---|
| CCX282-B | DRUG | 250mg capsule, twice daily, 13 weeks |
| Placebo | DRUG | Placebo capsule, twice daily, 13 weeks |
Key Inclusion Criteria: * Male or female, between 18 and 75 years of age * Established diagnosis of celiac disease * Subject has been following a strict gluten-free diet for at least 24 months Key Exclusion Criteria: * History of any infection requiring intravenous antibiotics, a serious local in...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
CCX282-B is an investigational oral small molecule that has been studied in gastrointestinal disease, specifically celiac disease and Crohn disease. It was evaluated in Phase 2 clinical trials in adults with these conditions. It is not an approved therapy.
CCX282-B is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen holds the development program for this oral small molecule candidate in gastrointestinal indications.
CCX282-B is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA for any indication.
CCX282-B has been studied in completed Phase 2 trials. NCT00540657 evaluated CCX282-B in 90 patients with celiac disease in Finland. NCT00306215 studied 436 patients with moderate to severe Crohn disease across multiple countries. NCT00102921 studied 70 patients with moderate to severe Crohn disease in the United States.
No, CCX282-B is not FDA approved. It is an investigational small molecule that has completed Phase 2 clinical development for celiac disease and Crohn disease. No regulatory approval has been granted for any indication.