ArticleInflammatory intestinal diseases2020
A Multicentre, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of the S1P Receptor Agonist KRP203 in Patients with Moderately Active Refractory Ulcerative Colitis.
Article in Inflammatory intestinal diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- S1P receptor modulators for moderate-to-severe ulcerative colitis: a systematic review, meta-analysis, and trial sequential analysis.Journal of gastroenterology · 2026Pooled it
- Sphingosine 1-Phosphate (S1P) Receptor Modulators as an Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Digestive diseases and sciences · 2026Pooled it
- Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective.United European gastroenterology journal · 2024Pooled it
- Efficacy and safety of berberine plus 5-ASA for ulcerative colitis: A systematic review and meta-analysis.PloS one · 2024Pooled it
- EngineeredActa pharmaceutica Sinica. B · 2025Article
- Efficacy and safety of sphingosine-1-phosphate receptor modulators in the management of inflammatory bowel disease: a systematic review and meta-analysis.Gastroenterology and hepatology from bed to bench · 2025Review
- The Multifaceted Impact of Bioactive Lipids on Gut Health and Disease.International journal of molecular sciences · 2024Review
- Targeting the Sphingosine-1-Phosphate Pathway: New Opportunities in Inflammatory Bowel Disease Management.Drugs · 2024Review
- Safety and Effectiveness of Thiopurines and Small Molecules in Elderly Patients with Inflammatory Bowel Diseases.Journal of clinical medicine · 2024Review
- Understanding the molecular mechanisms of anti-trafficking therapies and their clinical relevance in inflammatory bowel disease.Mucosal immunology · 2023Review
- The role of sphingosine-1-phosphate in autophagy and related disorders.Cell death discovery · 2023Review
- Review
- Unveiling the biological role of sphingosine-1-phosphate receptor modulators in inflammatory bowel diseases.World journal of gastroenterology · 2023Review
- Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials.Clinical and experimental gastroenterology · 2023Review
- The role of sphingosine-1-phosphate in the development and progression of Parkinson's disease.Frontiers in cellular neuroscience · 2023Review
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2022Review
- The role of Th17 cells in inflammatory bowel disease and the research progress.Frontiers in immunology · 2022Review
- Emerging therapeutic options in inflammatory bowel disease.World journal of gastroenterology · 2021Review
- Targeting Leukocyte Trafficking in Inflammatory Bowel Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsKRP203 is a potent oral agonist of the sphingosine-1-phosphate receptor subtype 1 that induces the sequestration of peripheral lymphocytes, thereby potentially reducing the number of activated lymphocytes circulating to the gastrointestinal tract.
methodsWe conducted a multicentre, double-blind, placebo-controlled, parallel-group, proof-of-concept study to evaluate the efficacy, safety, and tolerability of KRP203 in patients with moderately active 5-aminosalicylate-refractory ulcerative colitis (UC). Patients were randomly assigned to receive 1.2 mg KRP203 or placebo daily for 8 weeks. Primary efficacy variable was clinical remission, defined as partial Mayo Score 0-1 and modified Baron Score 0-1 with rectal bleeding subscore 0.
resultsKRP203 was safe and well tolerated overall. The most common adverse events (AEs) were gastrointestinal disorders and headache. Importantly, no KRP203-related cardiac AEs were reported. Total peripheral lymphocytes and selectively affected lymphocyte subtypes decreased, causing marked decreases in naive and central memory CD4+ and CD8+ T cells, and also in B cells. Clinical remission occurred in 2/14 (14%) patients under KRP203, compared with 0/8 (0%) under placebo.
conclusionsOverall, KRP203 was safe and well tolerated by patients with UC. Importantly, no cardiac AEs were reported. Although KRP203 did not meet the minimum clinically relevant threshold for efficacy, the results may suggest that KRP203 treatment is superior to placebo. However, in this small study population, the difference was insignificant. Based on these data, studies with an improved design and a larger population should be considered.
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Registered trials
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 OpenQuestion graph.