Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ozanimod

• Registration Number: NCT03665610
• Lead Sponsor: Celgene

Brief Summary

Study Design

This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. This study consists of two parts:

* Mandatory data collection for safety: Subjects enrolled in the parent studies were consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy test results, and concomitant medications up to the 75 ± 10 days postdose follow-up collected and reported in this study.

* Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU) at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose follow-up. After signing the informed consent form, eligible subjects will be randomized to one of three sequences with stratification by site/protocol. Subjects will return to the CRU in the morning (between approximately 8 am and 11 am) once at each of the four time windows.

Study Population The approximate number of subjects will be 230 for safety data and 129 for PK/PD data.

Length of Study The study duration is up to 84 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study Start: 2018-09-10
• Study First Posted: 2018-09-11
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1. For the mandatory data collection for safety, subjects who enrolled in the Phase 1 studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or investigational product (IP) as applicable per the parent studies are eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.

2. For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:

   1. Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up.
   2. Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.
   3. Subjects must be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements or restrictions.

Exclusion Criteria

No Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mandatory Safety Population	ozanimod	All subjects who enrolled in studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or IP (per parent studies), excluding subjects who discontinued during Period 1 of study RPC01-1913.

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)	The incidence, severity, and relationship of TEAEs.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics - lymphocyte subsets	Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)	Lymphocyte subsets will be measured using the immune cell monitoring epigenetic platform
Pharmacodynamics - absolute lymphocyte count (ALC)	Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)	The absolute lymphocyte count (ALC) will be determined via hematology test

Trial Locations

Locations (2)

PPD Phase 1 Clinic; 🇺🇸 Austin, Texas, United States

ICON Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States