Trial reportAdvances in therapy2026
Efficacy and Safety of Ravagalimab in Patients with Moderate-to-Severe Ulcerative Colitis: Data from a Phase 2a Trial.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03695185 (A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Who cites it
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Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe monoclonal antibody ravagalimab is a potent antagonist to cluster of differentiation 40 (CD40), which is elevated in inflammatory diseases such as ulcerative colitis (UC). This phase 2a, open-label trial evaluated the efficacy and safety of ravagalimab as induction and maintenance treatment in patients with moderate-to-severe UC and who had inadequate response, loss of response, or intolerance to prior therapy.
methodsEligible adult patients with an adapted Mayo Score ≥ 5 points and an endoscopic subscore ≥ 2 received ravagalimab 600 mg intravenously at baseline, then 300 mg subcutaneously every 2 weeks from weeks 2 through 10. Patients with a clinical response at week 12 continued into the maintenance period (ravagalimab 300 mg subcutaneously every 2 weeks through week 102). The study was terminated early upon achieving the trial objectives at completion of the induction period.
resultsA total of 42 patients were enrolled and received at least one dose of ravagalimab. At baseline, over 80% of patients had severe endoscopic disease and failed/were intolerant to multiple prior biological/Janus kinase (JAK) therapies. Endoscopic improvement (Mayo endoscopic subscore of ≤ 1 without friability by independent central review) at week 8, the primary efficacy endpoint, was achieved in 18% of ravagalimab-treated patients. Ravagalimab also led to clinical remission per adapted Mayo Score (stool frequency score ≤ 1 and not greater than baseline, rectal bleeding score of 0, and endoscopic subscore ≤ 1 without friability) and clinical response per adapted Mayo Score (a decrease of ≥ 30% and ≥ 2 points from baseline and a decrease in rectal bleeding score of ≥ 1 or an absolute rectal bleeding score of ≤ 1) at week 8 in 9.5% and 40.2% of patients, respectively. In addition, gut biopsy analyses demonstrated target engagement, and pharmacodynamic modulation of a CD40-inducible gene (ICAM1) and CD40-dependent plasma cells. Ravagalimab was generally safe and well tolerated.
conclusionRavagalimab treatment was efficacious and safe in patients with moderate-to-severe UC in this proof-of-concept study. Graphical Abstract available for this article.
trial registrationClinicalTrials.gov identifier, NCT03695185.
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