Multiple SclerosisPhase 4TERI-PKNCT04410965
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
A Phase 4 study testing TERIFLUNOMIDE in people with Multiple Sclerosis, run by Sanofi at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- TERIFLUNOMIDE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2020to 12 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to enrollment.
- Participant treated with BCRP inhibitors (such as cyclosporine, eltrombopag, gefitinib).
- Participant not suitable for participation, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- Any specific situation during study implementation/course that may rise ethics considerations.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Study duration per participant is approximately 28 weeks including a 24-week treatment period
- Conditions
- Multiple Sclerosis
- Being tested
- TERIFLUNOMIDE
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERIFLUNOMIDEDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| teriflunomide | Experimental | daily oral administration of teriflunomide 14 mg for 24 weeks Receives: Drug: TERIFLUNOMIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK exposure: Cmax
PK exposure Cmax will be estimated by PopPK analysis.
Measured: From Week 8 to Week 24
PK exposure: AUCtau
PK exposure AUCtau will be estimated by PopPK analysis
Measured: From Week 8 to Week 24
Secondary outcomes (1)
Participants with Serious Adverse Events and Adverse Events
Measured: Screening to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start20 May 2020
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410965
- Sponsor's protocol ID
- BDR16019
- Other IDs
- U1111-1233-0136
- Acronym
- TERI-PK
- Status last verified
- Sep 2025
- First submitted
- 28 May 2020
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
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.
PubMed 38311806
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04410965
- Acronym / sponsor ID
- TERI-PK / BDR16019
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study duration per participant is approximately 28 weeks including a 24-week treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teriflunomide | Experimental | Drug: TERIFLUNOMIDEdaily oral administration of teriflunomide 14 mg for 24 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TERIFLUNOMIDEPharmaceutical form:tablet Route of administration: oral | Drug | teriflunomide |
Primary outcome
PK exposure: Cmax
Time frame: From Week 8 to Week 24
PK exposure Cmax will be estimated by PopPK analysis.
PK exposure: AUCtau
Time frame: From Week 8 to Week 24
PK exposure AUCtau will be estimated by PopPK analysis
1 secondary outcome
Participants with Serious Adverse Events and Adverse Events
Time frame: Screening to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 38311806Quan 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.
- BDR16019 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TERIFLUNOMIDE in people with Multiple Sclerosis, run by Sanofi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK exposure: Cmax (time frame: From Week 8 to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.