Back to Clinical Trials

Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats

Studies 3

Trials 100

Overview Studies Clinical Trials

Completed PHASE3 INTERVENTIONAL NCT04410991

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

Detailed Description

Study duration varied per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study were offered to participate in a long term safety study.

Interventions

Name: Tolebrutinib

Type: DRUG

Description: Pharmaceutical form: Tablet Route of administration: Oral

Name: Teriflunomide HMR1726

Type: DRUG

Description: Pharmaceutical form: Tablet Route of administration: Oral

Name: Placebo to match Tolebrutinib

Type: DRUG

Description: Pharmaceutical form: Tablet Route of administration: Oral

Name: Placebo to match Teriflunomide

Type: DRUG

Description: Pharmaceutical form: Tablet Route of administration: Oral

Primary Outcomes

Measure: Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses

TimeFrame: Baseline (Day 1) to approximately 48 months

Description: Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for \>=24 hours with or without recovery, present at normal body temperature, and preceded by \>=30 days of clinical stability.

Trial Information

NCT ID

NCT04410991

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Sanofi

Last Updated

December 15, 2025

Related Peptides

Melanotan-I Melanotan-2