Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Duvakitug · 4 trials · 2 indications
Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading.
Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)
Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Clinical Remission per PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
| Arm | Type | Description |
|---|---|---|
| Duvakitug dose 1 | EXPERIMENTAL | Subcutaneous (SC) injection as per protocol |
| Du vakitug dose 2 | EXPERIMENTAL | SC injection as per protocol |
| Du vakitug dose 3 | EXPERIMENTAL | SC injection as per protocol |
| Placebo | PLACEBO_COMPARATOR | SC injection as per protocol |
| Duvakitug - dose 1 | EXPERIMENTAL | Subcutaneous (SC) injection as per protocol |
| Duvakitug - dose 2 | EXPERIMENTAL | SC injection as per protocol |
| Duvakitug - dose 3 | EXPERIMENTAL | SC injection as per protocol |
| Duvakitug Dose 2 | EXPERIMENTAL | SC injection as per protocol |
| Name | Type | Description |
|---|---|---|
| Duvakitug | DRUG | Pharmaceutical form:Injection solution-Route of administration:SC injection |
| Placebo | DRUG | Pharmaceutical form:Injection solution-Route of administration:SC injection |
Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development) * Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endosc...
| 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 |
Duvakitug is an investigational small molecule being developed for moderately to severely active ulcerative colitis and Crohn's disease. It is currently in Phase 3 clinical trials for both conditions. The drug is being studied in induction and maintenance trials to evaluate its efficacy and safety in patients with these inflammatory bowel diseases.
Duvakitug is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials for Duvakitug in ulcerative colitis and Crohn's disease.
Duvakitug is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Sanofi is currently running Phase 3 induction and maintenance studies for both ulcerative colitis and Crohn's disease.
Duvakitug is being studied in four Phase 3 trials. For Crohn's disease, trials NCT07184931 (induction) and NCT07184944 (maintenance) are recruiting. For ulcerative colitis, trials NCT07184996 (induction) and NCT07185009 (maintenance) are recruiting. All trials are randomized, double-blind, and placebo-controlled.
Yes, Duvakitug is being studied in moderately to severely active ulcerative colitis. Two Phase 3 trials are recruiting: NCT07184996, an induction study with 980 participants, and NCT07185009, a maintenance study with 751 participants. Both are randomized, double-blind, and placebo-controlled.
Yes, Duvakitug is being studied in moderately to severely active Crohn's disease. Two Phase 3 trials are recruiting: NCT07184931, an induction study with 980 participants, and NCT07184944, a maintenance study with 751 participants. Both are randomized, double-blind, and placebo-controlled.