Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TEV-48574 Dose Regiment B · 1 trial · 2 indications
Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: * stool frequency subscore of 0 or 1, * rectal bleeding subscore of 0, and * endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"
Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD
| Arm | Type | Description |
|---|---|---|
| TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574 Dose Regimen A for Crohn's Disease (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574 Dose Regimen B for Ulcerative Colitis (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574 Dose Regimen B for Crohn's Disease (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| Name | Type | Description |
|---|---|---|
| TEV-48574 Dose Regimen A | DRUG | Subcutaneous (sc) administration using a commercial sc infusion system |
| TEV-48574 Dose Regiment B | DRUG | Subcutaneous (sc) administration using a commercial sc infusion system |
Inclusion Criteria: * Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. * Re-induction- Participants who did not achieve clinical response and/or clinical rem...
| 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 |
TEV-48574 Dose Regiment B is an investigational small molecule being studied for the treatment of Crohn Disease. It is currently in Phase 2 clinical development, evaluated in a randomized, double-blind, controlled trial for patients with moderate to severe Crohn's disease or ulcerative colitis.
TEV-48574 Dose Regiment B is being developed by Sanofi, a company traded under the ticker SNY. The drug is an investigational small molecule in Phase 2 clinical trials for gastrointestinal conditions, specifically Crohn Disease.
TEV-48574 Dose Regiment B is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being studied in an active clinical trial for Crohn Disease and ulcerative colitis.
TEV-48574 Dose Regiment B is being studied in clinical trial NCT05668013, titled 'A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease.' This Phase 2 trial is active but not recruiting, with an enrollment of 247 participants.
TEV-48574 Dose Regiment B is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for Crohn Disease and ulcerative colitis, and its safety and efficacy have not yet been established.