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Also known as duvakitug
TEV-48574 · 1 trial · 2 indications
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.
| Arm | Type | Description |
|---|---|---|
| TEV-48574, 450 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 900 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 1800 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03. |
| TEV-48574, 450 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 900 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 1800 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03. |
| Placebo UC | PLACEBO_COMPARATOR | Matching Placebo |
| Placebo CD | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| TEV-48574 | DRUG | Subcutaneous infusion |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: * Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months * The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study * The participant is able to understand the nature of ...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
TEV-48574 is an investigational small molecule drug being developed by Teva Pharmaceutical Industries Limited for inflammatory bowel disease. It has been studied in a Phase 2 clinical trial in adults with moderate to severe Crohn disease or ulcerative colitis. It is not approved and remains in clinical development.
TEV-48574 is being studied as a treatment for moderate to severe Crohn disease in adults. Its Phase 2 trial also enrolled patients with ulcerative colitis. The drug is investigational, so it is not yet available as a prescribed therapy for Crohn disease outside of clinical research.
TEV-48574 targets TL1A, a protein involved in inflammatory signaling. By acting on TL1A, the small molecule is designed to modulate the inflammatory pathways associated with Crohn disease and ulcerative colitis. This target-directed approach is the basis for its development in gastrointestinal inflammatory conditions.
TEV-48574 is being developed by Teva Pharmaceutical Industries Limited, which trades on the Nasdaq under the ticker TEVA. Teva sponsored the Phase 2 study of the drug in Crohn disease and ulcerative colitis. The asset is part of the company's gastrointestinal pipeline.
TEV-48574 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication, including Crohn disease.
TEV-48574 has been evaluated in the Phase 2 trial NCT05499130, titled A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease. The completed trial enrolled 290 adults across the United States, Europe, Canada, Israel, and Japan. It was randomized, double blind, and placebo controlled.