Approval Probability
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Ravagalimab · 1 trial · 1 indication
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.
| 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. |
| 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). |
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...
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Ravagalimab is an investigational monoclonal antibody developed by AbbVie Inc. (ticker ABBV) for the treatment of moderate to severe ulcerative colitis. It is a CD40LG antagonist that has been studied in a Phase 2 clinical trial in patients who failed prior therapy. Ravagalimab is also referred to as Ravagalimab 600 mg.
Ravagalimab is being developed for moderate to severe ulcerative colitis (UC), a gastrointestinal condition. It was studied in patients with moderate to severe UC who had failed prior therapy. The drug remains investigational and is not approved for any indication.
Ravagalimab targets CD40LG, also known as CD40 ligand. It acts as an antagonist of this target. CD40LG is a molecular target involved in immune signaling, and Ravagalimab is a monoclonal antibody designed to block its activity in ulcerative colitis.
Ravagalimab is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating Ravagalimab in ulcerative colitis.
Ravagalimab is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 2 program in ulcerative colitis has been completed.
Ravagalimab was evaluated in one Phase 2 clinical trial, NCT03695185, titled a study to investigate how well Ravagalimab (ABBV-323) works and how safe it is in participants with moderate to severe ulcerative colitis who failed prior therapy. The trial enrolled 42 participants and is completed.