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...
| 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 |
DB adalimumab eow is a monoclonal antibody being developed for the treatment of Crohn's Disease, a type of inflammatory bowel disease. It is currently in Phase 3 clinical development and is intended for use in adult patients.
DB adalimumab eow is a monoclonal antibody that targets tumor necrosis factor (TNF), a key driver of inflammation in Crohn's Disease. By neutralizing TNF, it aims to reduce inflammation and promote remission in affected patients.
DB adalimumab eow is being developed by Abbott Laboratories, a global healthcare company. The company is listed on the stock exchange under the ticker symbol ABT.
DB adalimumab eow is in Phase 3 clinical development for Crohn's Disease. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed.
DB adalimumab eow has been studied in a Phase 3 clinical trial with the identifier NCT00055497. This randomized, double-blind, placebo-controlled trial enrolled 276 participants with Crohn's Disease and was conducted in the United States.
DB adalimumab eow is a formulation of adalimumab, a well-known TNF inhibitor. The 'eow' designation indicates an every-other-week dosing schedule. It is being developed specifically for Crohn's Disease and has completed a Phase 3 trial.