Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D9421-C · 2 trials · 1 indication
For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.
Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.
| Arm | Type | Description |
|---|---|---|
| D9421-C | EXPERIMENTAL | D9421-C 9 mg once daily |
| Mesalazine | ACTIVE_COMPARATOR | Mesalazine 1 g three times a day |
| 1 | ACTIVE_COMPARATOR | D9421-C 9 mg |
| 2 | ACTIVE_COMPARATOR | D9421-C 15 mg |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| D9421-C capsule 3 mg | DRUG | Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. |
| Mesalazine tablets | DRUG | Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. |
| D9421-C, 9mg | DRUG | D9421-C 9 mg was given once daily for 8 weeks. |
| D9421-C, 15mg | DRUG | D9421-C 15 mg was given once daily for 8 weeks. |
| Placebo | DRUG | D9421-C matching placebo was given once daily for 8 weeks. |
Inclusion Criteria: * 15 years of age or older * Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation ...
| 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 |
D9421-C is an investigational small molecule being studied for the treatment of active Crohn's Disease. It has been evaluated in clinical trials in Japan, including a Phase 2 study and a Phase 3 study, both of which are completed. The drug is not approved and remains in clinical development.
D9421-C is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has conducted clinical trials of D9421-C in Japan for the treatment of active Crohn's Disease.
D9421-C is in Phase 3 clinical development for Crohn's Disease. A Phase 3 study, NCT01514240, has been completed in Japan. The drug is investigational and has not been approved for any use.
D9421-C has been studied in two completed clinical trials in Japan. The first, NCT00573469, was a Phase 2 study comparing 9 mg and 15 mg doses against placebo in 75 patients with active Crohn's Disease. The second, NCT01514240, was a Phase 3 study of the 9 mg dose in 123 patients.
D9421-C is not FDA approved. It is an investigational drug that has completed Phase 2 and Phase 3 clinical trials in Japan for active Crohn's Disease. The drug remains in clinical development and has not been approved for marketing in any country.