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

Sponsor
Immunovant Sciences GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03863080
Collaborator
(none)
17
Enrollment
20
Locations
3
Arms
19.1
Actual Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label ExtensionRandomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Blinded
Primary Purpose:
Treatment
Official Title:
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
Actual Study Start Date :
May 21, 2019
Actual Primary Completion Date :
Oct 7, 2020
Actual Study Completion Date :
Dec 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regimen A

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

Drug: RVT-1401
Subcutaneous administration of RVT-1401
Experimental: Regimen B

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

Drug: RVT-1401
Subcutaneous administration of RVT-1401
Placebo Comparator: Placebo

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

Drug: RVT-1401
Subcutaneous administration of RVT-1401

Drug: Placebo
Subcutaneous administration of Placebo

Outcome Measures

Primary Outcome Measures

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

  2. Change from baseline in levels of total IgG and IgG subclasses (1-4) [Week 7]

  3. Change from baseline in levels of anti-AChR-IgG [Week 7]

Secondary Outcome Measures

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

  2. PK maximum concentration (Cmax) after first and last dose [Weeks 1 and 6]

  3. Concentration of RVT-1401 pre-dose (Ctrough) [Weeks 1-6]

  4. Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies [Weeks 1-18]

  5. Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score [Week 7]

  6. Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by ≥ 3 points from baseline [Week 7]

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

  8. Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points [Week 7]

  9. Change from baseline in the Myasthenia Gravis Composite Score (MGC) score [Week 7]

  10. Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by ≥3 points [Week 7]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IMC/Diagnostic and Medical Clinic Mobile Alabama United States 36604
2 Phoenix Neurological Associates Phoenix Arizona United States 85018
3 The Neurology Center of Southern California Carlsbad California United States 92011
4 UC Irvine - MDA ALS and Neuromuscular Center Orange California United States 92868
5 Care Access Research Pasadena California United States 91101
6 CSNA Colorado Springs Colorado United States 80907
7 Yale School of Medicine Department of Neurology New Haven Connecticut United States 06510
8 Neurological Services of Orlando Orlando Florida United States 32806
9 Rare Disease Research Atlanta Georgia United States 30318
10 University of Minnesota - Department of Neurology Minneapolis Minnesota United States 55455
11 Dent Institute Amherst New York United States 14221
12 University of Buffalo Buffalo New York United States 14260-1660
13 Hospital for Special Surgery New York New York United States 10021
14 Allegheny Neurological Associates Pittsburgh Pennsylvania United States 15212
15 UTSW James W. Aston Ambulatory Care Center - Neurology Clinic Dallas Texas United States 75390
16 University of Alberta Hospitals - Division of Pulmonary Medicine Edmonton Alberta Canada T6G 2G3
17 London Health Sciences Centre London Ontario Canada N6G 2V4
18 Ottawa Hospital Research Institute Ottawa Ontario Canada K1Y 4E9
19 University Health Network Toronto General Hospital Toronto Ontario Canada M5G 2C4
20 Montreal Neurological Institute and Hospital Montreal Quebec Canada H3A 2B4

Sponsors and Collaborators

  • Immunovant Sciences GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Immunovant Sciences GmbH
ClinicalTrials.gov Identifier:
NCT03863080
Other Study ID Numbers:
  • RVT-1401-2002
First Posted:
Mar 5, 2019
Last Update Posted:
Oct 8, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Immunovant Sciences GmbH
IMVT-1401
Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness

Study Results

No Results Posted as of Oct 8, 2021