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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• 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 (participant 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Participants who have withdrawn after randomization (eg, due to AEs or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 the OLE Period. Only participants 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
XML File Identifier: k4hJyQ2TTXfK1h/jRu7hSMCeZdA=
Page 19/34
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 participant: • 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 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 halflives
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

Study & Design

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