A Lactation Study in Women Receiving Treatment With Ozanimod

NCT06181630 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IM047-030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.

Conditions

Lactating Women; Breastfed Infants

Keywords

Ozanimod; BMS-986374

Outcome Measures

Primary Outcomes (4)

• Average concentration at steady state (Css-avg) in breast milk

  Predose; Up to 24 hours post dose

• Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk

  Predose; Up to 24 hours post dose

• Drug daily infant dose

  Predose; Up to 24 hours post dose

• Drug relative infant dose

  Predose; Up to 24 hours post dose

Secondary Outcomes (8)

• Number of participants with adverse events (AEs)

  Up to approximately 5 months

• Number of participants with clinical laboratory abnormalities

  Up to approximately 5 months

• Number of participants with vital sign abnormalities

  Up to approximately 5 months

• Number of participants with physical examination abnormalities

  Up to approximately 5 months

• Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)

  Predose; Up to 12 hours post dose

Study Arms (1)

Lactating women receiving treatment with Ozanimod and their infants

EXPERIMENTAL

Diagnostic Test: Breast milk, plasma, and blood samples

Interventions

Breast milk, plasma, and blood samples DIAGNOSTIC_TEST

Although this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study.

Lactating women receiving treatment with Ozanimod and their infants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
• Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
• Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
• Infant participant has normal weight for gestational age (above tenth percentile) at birth.

You may not qualify if:

• Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
• Adult participant is not breastfeeding or pumping milk.
• Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
• Infant participant was born less than 37 weeks gestation
• Other protocol-defined criteria apply.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113-2228, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Milk, Human; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)