A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
- Conditions
- Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)MedDRA version: 20.0Level: PTClassification code 10075688Term: Autoimmune demyelinating diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-003192-34-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 152
? Participants who are aged >=12 years at the time of signing Informed Consent Form
? Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
? Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
? Best corrected visual acuity (BCVA) better than 20/800 in both eyes at screening
? Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids (OCS) prior to and at the time of screening
? No contraindications to rescue treatments
? No contraindications to MRI
? For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
? Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
? History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
? Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
Exclusion Criteria Related to Previous or Concomitant Therapy
? Intravenous immunoglobulins (IVIg) within 4 weeks prior to screening
? Plasma exchange (PLEX) within 4 weeks prior to screening
? OCS, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)
? Tacrolimus or cyclosporine within 6 weeks prior to screening
? B-cell depleting agents, including rituximab (RTX) and ocrelizumab, within 6 months prior to baseline
? Methotrexate within 3 months prior to screening
? Neonatal Fc receptor antagonists within 6 months prior to screening
? IV cyclophosphamide within 6 months prior to screening
? Complement inhibitors within 6 months prior to screening
? Glatiramer acetate and IFN-ß within 1 month prior to screening
? Fumarates within 2 months prior to screening
? Teriflunomide within 2 years prior to screening
? Other MS disease-modifying treatments within 6 months prior to screening
? IL-6 inhibitory therapy at any time
? Total body irradiation, bone marrow transplantation, and autologous hematopoietic stem cell transplantation at any time
? T-cell depleting agents, including but not limited to alemtuzumab, at any time
? Anti-B-lymphocyte stimulator monoclonal antibody at any time
? Cladribine, mitoxantrone, or oral cyclophosphamide at any time
? Treatment with any investigational agent within 24 weeks or 5 drug-elimination half-lives of the investigational drug prior to screening
General Safety Exclusion Criteria
? Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
? Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
? Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
? Participants with positive screening tests for hepatitis B and C
? Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
? History of severe allergic reaction to a biologic agent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period;Secondary Objective: ?To evaluate the efficacy of satralizumab compared with placebo based on rate of adjudicated MOGAD relapses, presence of active lesions on magnetic resonance imaging (MRI) of the neuroaxis, rescue therapy use, inpatient hospitalizations, and proportion of relapse-free participants at 6-month intervals<br>?To evaluate the safety of satralizumab compared with placebo<br>;Primary end point(s): 1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC);Timepoint(s) of evaluation of this end point: 1. Up to approximately 44 months
- Secondary Outcome Measures
Name Time Method