NCT06126835 is a clinical trial of Ozanimod in Ulcerative Colitis, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT06126835?

NCT06126835 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT06126835?

Interventions in NCT06126835: Ozanimod, Conventional therapy, Advanced therapy.

What condition does NCT06126835 study?

NCT06126835 studies Ulcerative Colitis.

Is NCT06126835 still recruiting?

NCT06126835 is currently active, enrolled. Last updated 1 October 2024.

Last reviewed 2024-10-01 · How we verify

NCT06126835

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Active, enrolled Last updated 1 October 2024

What this trial tests

trial testing Ozanimod in Ulcerative Colitis in 2,828 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 August 2024

Primary endpoint
31 May 2031

30 June 2032

Quick facts

Lead sponsor	Bristol-Myers Squibb
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	2,828
Start date	26 August 2024
Primary completion	31 May 2031
Estimated completion	30 June 2032
Sites	1 location across United States

Drugs / interventions tested

Ozanimod (OZANIMOD) — full drug profile →
Conventional therapy — full drug profile →
Advanced therapy — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 49, female only, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment-insights from Phase II and III trials.
Massironi S, Furfaro F, Bencardino S, Allocca M, et al · · 2024 · cited 19× · PMID 38980426 · DOI 10.1007/s00535-024-02130-x

Verify or expand the search:

Other trials of Ozanimod

Trials testing the same drug.

NCT07271069 — Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis · recruiting
NCT06862960 — Ozanimod in Patients With Alzheimer's Disease · Phase 2 · not yet recruiting
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap · Phase 3 · recruiting
NCT06529406 — Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod · Phase 4 · recruiting
NCT06334094 — Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS · Phase 4 · withdrawn

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06126835 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 1 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06126835.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing