ArticleThe American journal of gastroenterology2025
Long-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results.
Article in The American journal of gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03301506 (ASSURE), which is not on this map. Cited by 15 papers.
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.
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Who cites it
15 citing papers in PubMed.
- Seladelpar in patients with primary biliary cholangitis and compensated cirrhosis: Efficacy and safety from RESPONSE and ASSURE studies.Hepatology communications · 2026Trial
- Hepatology: Emerging Paradigms in MASLD, Viral Hepatitis, Cholestatic Liver Disease, Portal Hypertension and Hepatocellular Carcinoma: Summary of the First Annual Paris International Liver Meeting 2026.Liver international : official journal of the International Association for the Study of the Liver · 2026Review
- Austrian Society of Gastroenterology and Hepatology (ÖGGH) consensus on primary biliary cholangitis.Wiener klinische Wochenschrift · 2026Article
- Review
- Current Treatment of Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Comprehensive Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026Review
- Review Article: Targeting Peroxisome Proliferator-Activated Receptors in Primary Biliary Cholangitis.Alimentary pharmacology & therapeutics · 2026Review
- [Research advances in autoimmune liver disease in 2025: toward precision regulation and personalized treatment].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Article
- Serum Metabolomic Profiling Reveals Potential Mechanisms and Biomarkers of Seladelpar Treatment in Patients With Primary Biliary Cholangitis.PPAR research · 2026Article
- New and emerging treatments for PBC-related pruritus.Drugs in context · 2026Review
- The Personalized Management of Primary Biliary Cholangitis in the Era of Precision Medicine: Current Challenges and Future Perspectives.Journal of personalized medicine · 2025Review
- Seladelpar Is Associated With a Sustained Reduction in Cholestatic Markers and a Consistent Safety Profile in Patients With PBC Treated Up to 48 Months in the Ongoing, Open-Label ASSURE Study.Gastroenterology & hepatology · 2025Article
- Fracture events in patients with primary biliary cholangitis during treatment with seladelpar in the phase III RESPONSE trial.Hepatology communications · 2025Article
- Sustained and Clinically Meaningful Improvements in Moderate to Severe Pruritus Patients With PBC Treated With Seladelpar: Results From the ASSURE Study Up to 30 Months.Gastroenterology & hepatology · 2025Article
- Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor.Biomedicines · 2025Review
- Consensus statements of the Hellenic Autoimmune Liver Diseases Study Group on the diagnosis and current management of primary biliary cholangitis.Annals of gastroenterologyArticle
Corrections and comments
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Authors and funding
22 authors.
Funding
Abstract
introductionThe objective of these analyses was to evaluate interim data from the ongoing, open-label, long-term efficacy and safety ASSURE study of seladelpar, a selective peroxisome proliferator-activated receptor δ agonist, in primary biliary cholangitis.
methodsPatients rolling over from the phase 3, randomized, placebo-controlled, 12-month RESPONSE study or with previous participation in earlier legacy seladelpar studies were enrolled. Interim evaluations included composite biochemical response (alkaline phosphatase <1.67 upper limit of normal, total bilirubin ≤ upper limit of normal, and alkaline phosphatase decrease ≥15%), pruritus numerical rating scale (NRS) change among patients with a baseline score ≥4, and safety.
resultsAt interim cutoff, 337 patients were enrolled and received ≥1 seladelpar 10 mg dose: 54 placebo-treated and 104 seladelpar-treated from RESPONSE and 179 from legacy studies. The composite response rate at RESPONSE completion was 62% (79/128) with seladelpar and 20% (13/65) with placebo. After 12 months in ASSURE, among patients who rolled over from RESPONSE, response rates were 72% (21/29) in patients continuing seladelpar and 94% (15/16) in crossover seladelpar patients. In legacy trial patients, response rates were 73% (120/164) and 70% (69/99) after 12 and 24 months of treatment in ASSURE, respectively. The NRS decrease at RESPONSE completion in seladelpar-treated patients with baseline NRS ≥4 (-3.4) was maintained after 6 additional months of treatment (-3.8); changes were similar in crossover seladelpar (-3.8) and legacy patients (-3.5) after 6 months of treatment in ASSURE. No seladelpar-related serious adverse events were reported. DISCUSSION: Seladelpar demonstrated durable improvements in cholestatic biomarkers and pruritus in patients with primary biliary cholangitis with up to 2 years of treatment and remained overall safe with long-term use. Clinicaltrials.gov: NCT03301506.
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