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

A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ozanimod

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase 1 Clinic
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The approximate number of subjects will be 230 for safety data (from parent studies RPC01-1912, RPC01-1913, and RPC01-1914) and 129 for PK/PD data (from parent studies RPC01-1913 and RPC01-1914).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mandatory Safety Population; 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.	Drug: ozanimod; ozanimod
Optional pharmacokinetic(s) and pharmacodynamics(s) population; 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 and had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celgene

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): January 10, 2019

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Ozanimod; Healthy Subjects; Pharmacodynamics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Ozanimod
• Other Study ID Numbers: RPC01-1915; U1111-1219-5905 (REGISTRY: WHO)

Drug and device information, study documents

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