Trial reportJournal of Crohn's & colitis2025
Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study.
Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04023396 (A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis), which is not on this map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
Who cites it
13 citing papers in PubMed.
- IBD Nurse-Led Clinical Pathways to Optimize Patient Safety in Advanced Therapies: A Narrative Review.Digestive diseases and sciences · 2026Review
- Review
- Comment on "Five-Year Outcomes and Disease Trajectories in Moderate-to-Severe Ulcerative Colitis: A Korean Multicenter Inception Cohort".Journal of gastroenterology and hepatology · 2026Article
- MicroRNAs as master regulators of macrophage function in atherosclerosis: From polarization to therapeutic potential.iScience · 2026Review
- Severity of surgical histopathological fibrosis predicted postoperative recurrence in Crohn's disease: a multi-center retrospective cohort study.Journal of gastroenterology · 2026Article
- Advanced Combination Therapy in Inflammatory Bowel Disease: What Does the Future Hold?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Advances in the Treatment of Ulcerative Colitis-From Conventional Therapies to Targeted Biologics and Small Molecules.International journal of molecular sciences · 2026Review
- Challenges and Treatment Strategies in Elderly Patients with Inflammatory Bowel Disease: A Systematic Review and Narrative Synthesis.Journal of personalized medicine · 2026Review
- Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Review
- Interpretation of the molecular mechanism and therapeutic potential of microRNA‑155 in cardiovascular and cerebrovascular diseases (Review).International journal of molecular medicine · 2026Review
- Engineered extracellular vesicles reprogram T cells by targeting PD-1 and PHB1 signaling in inflammatory bowel disease.Signal transduction and targeted therapy · 2025Article
- MicroRNAs as multifaceted regulators and therapeutic targets in ulcerative colitis.Frontiers in immunology · 2025Review
- Decoding STAT3: a new frontier in understanding and treating hyperoxic lung injury.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
BACKGROUND AND
aimsObefazimod is an oral small molecule that selectively enhances the expression of a single micro-RNA (miRNA), miR-124. Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severely active ulcerative colitis (UC) in a phase 2b induction trial. This analysis presents the 2-year outcome data of the open-label maintenance (OLM) study.
methodsPatients received placebo or obefazimod 25, 50, or 100 mg once-daily (od) during the induction trial and, irrespective of their clinical response, could enter the 96-week OLM study with obefazimod 50 mg od. Safety was monitored through monthly visits in the first year and quarterly visits in the second year. Efficacy was assessed at weeks 48 and 96 using nonresponder imputation (NRI) for missing data.
resultsOf 222 eligible patients, 217 were enrolled and 164 (75.6%) completed week 96 of the OLM study. Clinical response was achieved at weeks 48 and 96 in 177 (81.6%) and 158 (72.8%) patients and clinical remission in 119 (54.8%) and 114 (52.5%) of patients. A total of 133 (61.3%) and 128 (59.0%) patients showed endoscopic improvement, and 72 (33.2%) and 78 (35.9%) endoscopic remission. In total, 148/217 patients (68.2%) reported at least 1 treatment-emergent adverse event (TEAE). The most frequent TEAEs were COVID-19 (14.3%), headache (11.5%), UC (7.8%), and nasopharyngitis (6.9%). No new safety risks emerged over 96 weeks.
conclusionsThe 96-week OLM study supports the long-term efficacy and favorable safety profile of obefazimod 50 mg od. A phase 3 program with obefazimod in patients with moderate-to-severe UC is ongoing. TRIAL REGISTRATION NAME/NUMBER: A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate-to-severe UC. NCT04023396.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.