A Lactation Study in Women Receiving Treatment With Ozanimod

A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lactating Women; Breastfed Infants
• Intervention / Treatment: Diagnostic test: Breast milk, plasma, and blood samples

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT# and Site #.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactating women receiving treatment with Ozanimod and their infants	Diagnostic test: Breast milk, plasma, and blood samples; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Maximum observed concentration in breast milk over the dosing interval (Cmax)	Predose; Up to 24 hours post dose
Minimum observed concentration in breast milk over the dosing interval (Cmin)	Predose; Up to 24 hours post dose
Time to reach Cmax (Tmax)	Predose; Up to 24 hours post dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): June 16, 2025
• Study Completion (Estimated): June 16, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Ozanimod; BMS-986374
• Other Study ID Numbers: IM047-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No