Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

• Status: Recruiting
• Trial end date: 2023-09-29
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: (T,G)-A-L; Dimethyl Fumarate; Glatiramer Acetate; Interferons; Ofatumumab; Teriflunomide

Criteria

Inclusion Criteria

1. Male/female patients, 18 through 45 (inclusive) years of age.

2. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018).

3. Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.

4. Treatment Naïve patients, ≤ 3 years since first MS symptom.

5. Patient must be suitable to be treated with one of first line self-administered DMT-physician's choice

6. EDSS score 0-3 (inclusive).

7. At least 1 relapse or or 1 Gd+ enhanced lesion on T1in the year prior to Screening.

8. Neurologically stable within 1 month prior to first study drug administration Exclusion Criteria

1. Relapse between Screening and Baseline visits 2. Pregnancy or breastfeeding 3. Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception 4. Patients with an active chronic disease of the immune system other than MS or with immunodeficiency syndrome 5. Patients with a chronic active infection, until the infection is resolved. Where local regulation requires it, Sars-Cov-19 must be ruled out by the PCR test.