Evobrutinib compared to Avonex in participants with Relapsing Multiple Sclerosis
- Conditions
- Relapsing Multiple SclerosisMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-004700-19-BG
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 950
1.18 to 55 years of age at the time of signing the informed consent.
2.Are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria
3.One or more documented relapses within the 2 years before Screening
4. Have an EDSS score of 0 to 5.5 at Baseline
5. Are neurologically stable for = 30 days prior to both Screening and Baseline
6. Are female or male
a. Female participants are not pregnant or breastfeeding, and at least one of the following conditions
applies:
o Not a Woman of Child Bearing Potential OR
o If a Woman of Child Bearing Potential, use a highly effective contraceptive method AND a barrier method
7. Capable of giving signed informed consent
8. Participants must be contactable by email or telephone throughout the study.
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 950
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria
2.Disease duration > 10 years in participants with an EDSS = 2.0 at Screening
3.Immunologic disorder other than MS or any other condition requiring oral, intravenous, intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
4.History or current diagnosis of other neurological disorders that may mimic MS
5.History or current diagnosis of PML
6.Active, clinically significant viral, bacterial, or fungal infection, or any major episode of infection
7.History of or current diagnosis of active tuberculosis (TB) OR currently undergoing treatment for latent TB infection or untreated LTBI. TB skin test with purified protein derivative will not be performed at Screening
8.Indeterminate QuantiFERON-TB test results may be repeated once. If results continue to be indeterminate, T-SPOT will be used. If T-SPOT.TB is not available, the Medical Monitor should be contacted
9.Individuals with a diagnosis of hemochromatosis, Wilson’s disease, alpha-1-antitrypsin deficiency, or any other chronic liver disease including Gilbert’s disease
10. Individuals with elevated transferrin saturation (> 50% transferrin saturation in males;
and > 40% transferrin saturation in females) and/or with elevated ferritin levels > 500 µg/L
11.Individuals with sickle cell anemia, thalassemia and/or any chronic blood disorder requiring blood transfusions
12.History of splenectomy at any time, or any major surgery within 2 months prior to Screening
13.History of myocardial infarction or cerebrovascular event within 6 months prior to Screening, or current active angina pectoris, history of or current congestive heart failure NYHA Class III or Class IV, uncontrolled seizures, prolonged untreated hypertension, active GI bleeding, others
14.A history of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale at Screening
15.An episode of major depression within the last 6 months prior to Screening
16.History of cancer with the exceptions per protocol
17.Clinically significant abnormality on screening ECG
18.An active infective process or any other clinically significant abnormality on Screening Chest X-ray
19.Contraindication to Avonex or incompatibility with Avonex use
20.IV or oral glucocorticoids within 4 weeks prior to randomization
21.Treatment with monthly IV methylprednisolone
22.Treatment with beta-interferons or glatiramer acetate within 4 weeks prior to randomization
23.Treatment with dimethyl fumarate within 4 weeks prior to randomization
24.Treatment with teriflunomide within 12 weeks or after the accelerated elimination procedure 12 days prior to randomization
25.Use of lymphocyte trafficking blockers within 48 weeks prior to randomization
26.Use of IV Ig or plasmapheresis within 12 weeks prior to randomization
27. Treatment with rituximab and/or ocrelizumab
28. Treatment with any other B cell depleting therapy, BTK inhibitors (including evobrutinib), mitoxantrone, or lymphocyte-depleting therapies (e.g., alemtuzumab, antiCD4, cladribine, cyclophosphamide, total body irradiation, bone marrow transplantation).
29. Concomitant treatment with medications commonly used for symptom management of MS
30. Treatment with medical marijuana for MS symptoms, unless it is co
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superior efficacy with evobrutinib compared to Avonex in terms of Annualized Relapse Rate (ARR);Secondary Objective: a.To demonstrate the efficacy of evobrutinib relative to that of Avonex on disability progression<br>b.To demonstrate the efficacy of evobrutinib relative to that of Avonex on patient reported symptoms and functional status<br>c.To demonstrate the efficacy of evobrutinib relative to that of Avonex on magnetic resonance imaging (MRI) lesion parameters<br>d.To characterize the safety and tolerability of evobrutinib.<br>e. OLE period: To evaluate the long-term safety, efficacy, and HRQoL of evobrutinib for an additional up to 144 weeks.;Primary end point(s): ARR based on qualified relapses at Week 96 in participants with RMS;Timepoint(s) of evaluation of this end point: Week 96
- Secondary Outcome Measures
Name Time Method