Trial reportContemporary clinical trials2022
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program.
Trial report in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are 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.
Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Who cites it
15 citing papers in PubMed, 30 citations in OpenAlex.
- Review
- Inflammatory Bowel Disease: Understanding Therapeutic Effects of Distinct Molecular Inhibitors as the Key to Current and Future Advanced Therapeutic Strategies.Biomedicines · 2025Review
- Sphingosine-1-Phosphate (S1P) Receptor Modulators for the Treatment of Inflammatory Bowel Disease (IBD): Mechanisms, Clinical Evidence, and Practical Insights.Biomedicines · 2025Review
- Are single nucleotide polymorphisms underutilized for guiding treatment of inflammatory bowel disease?Immunology and cell biology · 2025Review
- Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems.Clinical and experimental medicine · 2025Review
- Drug Development in Inflammatory Bowel Diseases: What Is Next?Pharmaceuticals (Basel, Switzerland) · 2025Review
- Predicting transcriptional responses to novel chemical perturbations using deep generative model for drug discovery.Nature communications · 2024Article
- Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment-insights from Phase II and III trials.Journal of gastroenterology · 2024Review
- [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- Risk and management of post-operative infectious complications in inflammatory bowel disease: A systematic review.World journal of gastrointestinal surgery · 2023Article
- The Future of Advanced Therapies for Pediatric Crohn's Disease.Paediatric drugs · 2023Article
- Horizon scanning: new and future therapies in the management of inflammatory bowel disease.eGastroenterology · 2023Review
- Dual-Targeted Therapy in Pediatric Inflammatory Bowel Disease: A Comprehensive Review.Paediatric drugs · 2023Review
- Unmet Challenges in Patients with Crohn's Disease.Journal of clinical medicine · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 4 countries.
Funding
Abstract
backgroundOzanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treatment of moderately to severely active ulcerative colitis and relapsing multiple sclerosis, showed clinical, endoscopic, and histological benefit in the phase 2 STEPSTONE trial for Crohn's disease (CD). We aim to describe the trial design of the YELLOWSTONE phase 3 program evaluating the safety and efficacy of ozanimod in patients with moderately to severely active CD.
methodsThe YELLOWSTONE program consists of phase 3, randomized, double-blind, placebo-controlled induction (NCT03440372 and NCT03440385) and maintenance (NCT03464097) trials and an open-label extension (OLE) study (NCT03467958). Patients with inadequate response or intolerance to ≥1 CD treatment are randomized to receive daily ozanimod 0.92 mg (equivalent to ozanimod HCl 1 mg) or placebo for 12 weeks during induction. Those who respond to ozanimod are rerandomized to continue ozanimod or placebo maintenance therapy for 52 weeks. Patients who do not meet criteria for maintenance, experience relapse during maintenance, or complete maintenance or ≥ 1 year of STEPSTONE are eligible for open-label treatment for up to 234 weeks. Efficacy endpoints include clinical, endoscopic, and histologic outcomes.
resultsExpected 2023 (induction studies), 2024 (maintenance study), and 2026 (OLE).
conclusionYELLOWSTONE will provide pivotal phase 3 data on the safety and efficacy of ozanimod in patients with moderately to severely active CD using state-of-the-art methods, including centrally read endoscopic and histologic measurements, along with subjective assessments of symptom control based on the Crohn's Disease Activity Index. These studies could enable approval of ozanimod as a new CD therapy. CLINICAL TRIAL REGISTRATION NUMBERS: NCT03440372, NCT03440385, NCT03464097, NCT03467958.
Indexed as
Identifiers
What OpenQuestion holds
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.