Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DB adalimumab eow · 1 trial · 1 indication
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Arm | Type | Description |
|---|---|---|
| Double-blind (DB) adalimumab placebo | PLACEBO_COMPARATOR | Double-blind nonactive matching subcutaneous injection |
| Double-blind adalimumab 40 mg every other week (eow) | EXPERIMENTAL | Double-blind adalimumab 40 mg eow by subcutaneous injection |
| Double-blind adalimumab 40 mg every week (ew) | EXPERIMENTAL | Double-blind adalimumab 40 mg every week by subcutaneous injection |
| Open-label adalimumab 40 mg | EXPERIMENTAL | Open-label adalimumab 40 mg eow or ew by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Double-blind (DB) adalimumab placebo | BIOLOGICAL | Double-blind nonactive matching subcutaneous injection |
| DB adalimumab 40 mg eow | BIOLOGICAL | Double-blind adalimumab 40 mg every other week by subcutaneous injection |
| DB adalimumab 40 mg ew | BIOLOGICAL | Double-blind adalimumab 40 mg every week by subcutaneous injection |
| OL adalimumab 40 mg | BIOLOGICAL | Open-label adalimumab every other week or every week by subcutaneous injection |
Inclusion: * Patient must have successfully completed the induction study NCT00055523 * Diagnosis of Crohn's disease * Willing and able to give informed consent Exclusion: * Diagnosis of ulcerative colitis * Pregnancy or breastfeeding * Previous use of infliximab or other anti-TNF antagonists * P...
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 |
DB adalimumab eow is an investigational monoclonal antibody therapy studied for Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract. It was evaluated in a Phase 3 clinical trial in adults with Crohn's disease. The every-other-week dosing schedule is reflected in the name.
DB adalimumab eow is being developed by Abbott Laboratories, which trades under the ticker symbol ABT. Abbott conducted the Phase 3 trial of this monoclonal antibody in Crohn's disease.
DB adalimumab eow is in Phase 3 development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial has been completed, and no active trials are currently listed for this asset.
DB adalimumab eow was studied in one completed Phase 3 trial, NCT00055497, titled Remission in Subjects With Crohn's Disease, 1 Year Phase. The trial enrolled 276 adults in the United States and used a randomized, double-blind, placebo-controlled design.