A Study of RVT-1401 in Myasthenia Gravis (MG) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03863080
• Date of registration: 20/02/2019
• Prospective Registration: Yes
• Primary sponsor: Immunovant Sciences GmbH
• Public title: A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
• Scientific title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
• Date of first enrolment: May 21, 2019
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03863080
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female = 18 years of age.

2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of
a respirator for the duration of the study as judged by the Investigator.

3. QMG score =12 at Screening and Baseline.

Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for
immunomodulation within 6 months prior to first dosing.

2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or
plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.

3. Thymectomy performed < 12 months prior to screening.

4. Total IgG level <6 g/L (at screening).

5. Absolute neutrophil count <1500 cells/mm3(at screening).

Other, more specific exclusion criteria are defined in the protocol



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: Placebo

Drug: RVT-1401

Primary Outcome(s)

Change from baseline in levels of total IgG and IgG subclasses (1-4) [Time Frame: Week 7]

Assessment of safety by analysis of adverse events (AEs) data [Time Frame: Weeks 1-18]

Change from baseline in levels of anti-AChR-IgG [Time Frame: Week 7]

Secondary Outcome(s)

Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score [Time Frame: Week 7]

Change from baseline in the Myasthenia Gravis Quality of Life 15 revised Score (MG-QOL 15r) score [Time Frame: Week 7]

Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by = 3 points from baseline [Time Frame: Week 7]

Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by =3 points [Time Frame: Week 7]

Change from baseline in the Myasthenia Gravis Composite Score (MGC) score [Time Frame: Week 7]

Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score [Time Frame: Week 7]

Concentration of RVT-1401 pre-dose (Ctrough) [Time Frame: Weeks 1-6]

PK maximum concentration (Cmax) after first and last dose [Time Frame: Weeks 1 and 6]

Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies [Time Frame: Weeks 1-18]

PK Parameters of AUC (0-168 h) after first and last dose [Time Frame: Weeks 1 and 6]

Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by =2 points [Time Frame: Week 7]

Secondary ID(s)

RVT-1401-2002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors