Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ravagalimab · 2 trials · 2 indications
Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Incidence of anti-drug antibodies
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
| Arm | Type | Description |
|---|---|---|
| Ravagalimab 600 mg/300 mg | EXPERIMENTAL | Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. |
| Ravagalimab | EXPERIMENTAL | Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days |
| Name | Type | Description |
|---|---|---|
| Ravagalimab 600 mg | DRUG | Ravagalimab 600 mg was administered intravenously (IV). |
| Ravagalimab 300 mg | DRUG | Ravagalimab 300 mg was administered subcutaneously (SC). |
| Ravagalimab | DRUG | Subcutaneous Injection |
Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. * Diagnosis of UC for at least 3 months prior to Baseline...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Ravagalimab is an investigational antibody being studied for ulcerative colitis (UC) and in healthy volunteers. It is being developed by AbbVie Inc. (ABBV) and is currently in clinical development, with studies completed in moderate to severe ulcerative colitis and in healthy participants.
Ravagalimab is a monoclonal antibody, indicated by its -mab suffix. Its specific molecular target is not disclosed in available information. The drug is being studied for its potential role in treating ulcerative colitis, though the exact mechanism of action has not been publicly detailed.
Ravagalimab is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy in ulcerative colitis and healthy volunteers.
Ravagalimab is in Phase 1 and Phase 2 clinical development. A Phase 2 study in ulcerative colitis and a Phase 1 study in healthy volunteers have both been completed. The drug is investigational and has not been approved by regulatory authorities.
Ravagalimab has been studied in two completed trials. NCT03695185 was a Phase 2 study in participants with moderate to severe ulcerative colitis who failed prior therapy, enrolling 42 participants. NCT06402513 was a Phase 1 study in healthy adults assessing a subcutaneous formulation, enrolling 12 participants.
Yes, Ravagalimab is also known as ABBV-323. The Phase 2 clinical trial NCT03695185 refers to the drug as Ravagalimab (ABBV-323), confirming that both names refer to the same investigational antibody being developed by AbbVie.