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

Immunovant

Status and phase: Completed; Phase 2

Conditions: Myasthenia Gravis

Treatments: Drug: RVT-1401; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03863080

RVT-1401-2002

Details and patient eligibility

About

The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups, including a placebo group

Regimen A

Experimental group

Description:

RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)

Treatment:

Drug: RVT-1401

Regimen B

Experimental group

Description:

RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)

Treatment:

Drug: RVT-1401

Placebo

Placebo Comparator group

Description:

Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)

Treatment:

Drug: RVT-1401

Drug: Placebo