NCT03856619 (SAFE) is a Phase 4 clinical trial of TERIFLUNOMIDE HMR1726 in Relapsing Multiple Sclerosis, sponsored by Sanofi.

Who is sponsoring NCT03856619?

NCT03856619 is sponsored by Sanofi.

What drugs are being tested in NCT03856619?

Interventions in NCT03856619: TERIFLUNOMIDE HMR1726.

What condition does NCT03856619 study?

NCT03856619 studies Relapsing Multiple Sclerosis.

Is NCT03856619 still recruiting?

NCT03856619 is currently completed. Last updated 19 April 2023.

Last reviewed 2023-04-19 · How we verify

NCT03856619: SAFE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Completed Phase 4 Last updated 19 April 2023

What this trial tests

Phase 4 trial testing TERIFLUNOMIDE HMR1726 in Relapsing Multiple Sclerosis in 121 participants. Completed in 13 May 2022.

Timeline

27 March 2019

Primary endpoint
13 May 2022

13 May 2022

Quick facts

Lead sponsor	Sanofi
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	121
Start date	27 March 2019
Primary completion	13 May 2022
Estimated completion	13 May 2022
Sites	14 locations across India

Drugs / interventions tested

TERIFLUNOMIDE HMR1726 — full drug profile →

Conditions studied

Relapsing Multiple Sclerosis — all drugs for Relapsing Multiple Sclerosis →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Relapsing Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis. Secondary Objective: To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Relapsing Multiple Sclerosis

Currently open trials in the same condition.

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NCT06846281 — Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Scle · Phase 3 · recruiting
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub · Phase 3 · recruiting
NCT07483450 — A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Rel · Phase 4 · recruiting
NCT06847724 — Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Partici · Phase 3 · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03856619 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 19 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03856619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing