A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis

Phase 1

• Conditions: Generalized Myasthenia Gravis (gMG); MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-004436-21-DK
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Age >= 12 years (or >= 18 years in France) at time of signing Informed Consent Form
• Confirmed diagnosis of gMG meeting the following criteria:
- Documented history of myasthenic weakness
- MG severity of MGFA Class II, III, or IV (Patients with MG Class IV at participating sites in France are excluded from the study) at screening
- The confirmation of the diagnosis has to be documented and supported by positive serologic test for one of the three antibody types: anti- AChR, anti- MuSK or anti- LRP4 at screening (antibody status must be confirmed by the central laboratory for all antibody types). For sites in Germany and the Netherlands, confirmation of the diagnosis has to be documented and supported by pre-existing positive serologic test results for one of the three antibody types (anti-AChR, anti-MuSK, or anti-LRP4), which must have been ordered by a health care professional (HCP) for the patient as part of the patient’s historical SOC
• A total MG-ADL score of >=5 points at screening with more than 50% of this score attributed to non-ocular items
• Ongoing gMG treatment at a stable dose and not exceeding the maximum protocol allowed doses
• No contraindication to at least one of the rescue treatments: IVIg, PE, or high dose corticosteroids
• For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) 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: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 147
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

Exclusion Criteria Related to Myasthenia Gravis (MG):
• History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
• History of thymectomy within 6 months prior to screening
• Ocular MG (Myasthenia Gravis Foundation of America [MGFA] Class I). In France, MGFA Class IV MG at screening
• Use of IVIg or subcutaneous immunoglobulin (SCIg) within 6 weeks prior to randomization/Day 1
• Use of PE within 8 weeks prior to randomization/Day 1
• Any surgical procedure (except for non-ophthalmic minor surgeries) within 4 weeks prior to screening and planned surgical procedure (except non-ophthalmic minor surgeries) during the study

Study & Design

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