Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks

NCT04410965 | Completed Phase 4

• 2 other identifiers: BDR16019U1111-1233-0136
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: Evaluate the relationship between ABCG2 mutation (rs2231142) and teriflunomide exposure, during 6-month treatment with teriflunomide 14 mg Secondary Objective: Characterize the safety (AEs, such as ALT enhancement, hair thinning, diarrhea, nausea, etc.) during 6-month treatment with teriflunomide

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• PK exposure: Cmax

  PK exposure Cmax will be estimated by PopPK analysis.

  From Week 8 to Week 24

• PK exposure: AUCtau

  PK exposure AUCtau will be estimated by PopPK analysis

  From Week 8 to Week 24

Secondary Outcomes (1)

• Participants with Serious Adverse Events and Adverse Events

  Screening to Week 24

Study Arms (1)

teriflunomide

EXPERIMENTAL

daily oral administration of teriflunomide 14 mg for 24 weeks

Drug: TERIFLUNOMIDE

Interventions

TERIFLUNOMIDE DRUG

Pharmaceutical form:tablet Route of administration: oral

teriflunomide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all the following criteria apply:
• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Participants EDSS score ≤ 5.5 according to the diagnosis of the neurologist (using the 2017 Revised McDonald Diagnostic Criteria for MS) and upon treatment initiation with teriflunomide according to the approved product information in China.
• Participants will be genotyped for the rs2231142 mutation, enrolled 80 participants should include: 40 wildtype patients, 40 patients with ABCG2 (rs2231142) mutation
• Male and/or female participants:
• Male participants: A male participant must agree to use contraception during the intervention period and undergo the accelerated eliminated procedure after the last dose of study intervention and refrain from donating sperm during this period.
• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the intervention period and undergo the accelerated elimination procedure (if necessary) after the last dose of study intervention.
• Participants who has signed written informed consent prior to entering the screening phase of the study

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participant not willing /being able to complete the questionnaires and examination.
• Participants who have taken leflunomide within 2 years prior to screening.
• Participants who have taken teriflunomide within 2 years prior to screening.
• Participants with severe hepatic impairment, including active hepatitis B/C diagnosed.
• Known history of active tuberculosis (TB) or latent TB infection not adequately treated, either diagnosed by standard medical practice or guidelines.
• Relapse within 30 days prior to enrollment.
• Participants who have any contraindications to AUBAGIO according to the local product insert leaflet.
• History of a hypersensitivity of teriflunomide, leflunomide, or any the inactive ingredients in Aubagio.
• Human immunodeficiency virus (HIV) positive patients.
• Participants treated with:
• glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to enrollment.
• fingolimod, or intravenous immunoglobulins within 3 months prior to enrollment.
• natalizumab, other immunosuppressant or immunomodulatory agents, such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 24 weeks prior to enrollment.
• cladribine or mitoxantrone within 2 years prior to enrollment.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number

China, China

Location

Related Publications (1)

• Quan C, Zhou H, Yang H, Jiao Z, Zhang M, Zhang B, Tan G, Bu B, Jin T, Li C, Xue Q, Dong H, Shi F, Qin X, Zhang X, Gao F, Zhang H, Wang J, Hu X, Chen Y, Liu J, Qiu W. Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study. Chin Med J (Engl). 2025 Feb 20;138(4):452-458. doi: 10.1097/CM9.0000000000002990. Epub 2024 Feb 5.

  PMID: 38311806 DERIVED

Related Links

• BDR16019 Plain Language Results Summary

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  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: May 28, 2020
• First Posted: June 1, 2020
• Study Start: May 20, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)