A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2016-001448-21-PL
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Participants with a diagnosis of RMS (may include participants with SPMS with superimposed relapses provided they meet the other criteria) in accordance with revised McDonald criteria for MS and Lublin and Reingold
2. Male or female aged 18 to 65 years
3. One or more documented relapses within the 2 years before Screening with either: a) One relapse which occurred within the last year prior to randomization or b) the presence of at least 1 Gd+ T1 lesion within 6 months prior to randomization would make the patient eligible.
4. EDSS score of 0 to 6 at Baseline
5. Women of childbearing potential must use a supplementary barrier method together with a highly effective method of contraception for 4 weeks prior to randomization, throughout the trial, and for 90 days after the last dose of IMP. Male subjects and their female partners must also use the above.
6. Signed and dated informed consent (participants must be able to understand the informed consent) indicating that the participant has been informed of all the pertinent aspects of the trial prior to enrolment and will comply with the requirements of the protocol.

For the open-label extension period:
Participants who have withdrawn after randomization (eg, due to AEs or lack of efficacy) will not be replaced and will not be eligible to participate in a OLE Period. Only subjects who have completed the 48 - week main study are eligible to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 248
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Progressive MS
• Disease duration > 15 years in participants with EDSS of 2 or less
• Use of the following, as determined in the protocol ; rituximab, ocrelizumab, mitoxantrone, or lymphocyte-depleting therapies, lymphocyte trafficking blockers (eg, natalizumab, fingolimod), IV Igs, plasmapheresis, immunosuppressive treatments, B-interferons or glatiramer acetate, Systemic glucocorticoids, teriflunomide, daclizumab
• Exposure to Tecfidera within 6 months prior to randomization
• Any allergy, contraindication, or inability to tolerate Tecfidera
• Treatment with dalfampridine (fampridine, Ampyra) unless on a stable dose for = 30 days prior to randomization
• Inability to comply with MRI scanning
• Immunologic disorder other than MS, with the exception of secondary well-controlled diabetes or thyroid disorder, or any other condition requiring oral, IV, intramuscular, or intra-articular corticosteroid therapy
• Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
• Severe drug allergy or history of anaphylaxis, or allergy to the IMP or any of its incipients
• Active, clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of Screening, or completion of oral anti-infectives within 2 weeks before or during Screening, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.
• History of or positive testing for HIV, HCV antibody and/or polymerase chain reaction, HBsAg (+) and/or hepatitis B core total, and/or IgM antibody (+) at Screening.
• The subject: • Has a history of or current diagnosis of active tuberculosis (TB) or
• Is currently undergoing treatment for latent TB infection (LTBI) or
• Has an untreated LTBI or • Has a positive QuantiFERON®-TB test at Screening.
• Indeterminate QuantiFERON
• Participants with current household contacts with active TB will also be excluded
• History of splenectomy or any major surgery within 2 months prior to Screening
• History of myocardial infarction or cerebrovascular event as per the protocol
• History of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of Columbia-Suicide Severity Rating Scale (C-SSRS)
• An episode of major depression within the last 6 months prior to Screening
• On anticoagulation, fish oil supplements, or antiplatelet therapy other than daily aspirin for cardioprotection and treatment of Tecfidera induced flushing
• History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin
• Breastfeeding/lactating or pregnant women
• Participation in any investigational drug trial within 1 month or 5 half-lives of the investigational drug, whichever is longest, prior to Screening
• Participants currently receiving (or unable to stop using prior to receiving the first dose of IMP) medications or herbal supplements known to be potent inhibitors of CYP3A
• History of or current alcohol or substance abuse
• Clinically significant abnormality on electrocardiogram or screening chest X-ray
• Clinically significant laboratory abnormality

Note: for participants participating in the OLE Period after receiving Tecfidera during 48-week main

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified