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

Primary Purpose

Myasthenia Gravis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RVT-1401
Placebo
Sponsored by
Immunovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis focused on measuring IMVT-1401

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IMC/Diagnostic and Medical Clinic
  • Phoenix Neurological Associates
  • The Neurology Center of Southern California
  • UC Irvine - MDA ALS and Neuromuscular Center
  • Care Access Research
  • CSNA
  • Yale School of Medicine Department of Neurology
  • Neurological Services of Orlando
  • Rare Disease Research
  • University of Minnesota - Department of Neurology
  • Dent Institute
  • University of Buffalo
  • Hospital for Special Surgery
  • Allegheny Neurological Associates
  • UTSW James W. Aston Ambulatory Care Center - Neurology Clinic
  • University of Alberta Hospitals - Division of Pulmonary Medicine
  • London Health Sciences Centre
  • Ottawa Hospital Research Institute
  • University Health Network Toronto General Hospital
  • Montreal Neurological Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Regimen A

Regimen B

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Assessment of safety by analysis of adverse events (AEs) data
Change from baseline in levels of total IgG and IgG subclasses (1-4)
Change from baseline in levels of anti-AChR-IgG

Secondary Outcome Measures

PK Parameters of AUC (0-168 h) after first and last dose
PK maximum concentration (Cmax) after first and last dose
Concentration of RVT-1401 pre-dose (Ctrough)
Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies
Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score
Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by ≥ 3 points from baseline
Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points
Change from baseline in the Myasthenia Gravis Composite Score (MGC) score
Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by ≥3 points
Change from baseline in the Myasthenia Gravis Quality of Life 15 revised Score (MG-QOL 15r) score

Full Information

First Posted
February 20, 2019
Last Updated
October 6, 2021
Sponsor
Immunovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03863080
Brief Title
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Official Title
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
IMVT-1401

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
Intervention Type
Drug
Intervention Name(s)
RVT-1401
Intervention Description
Subcutaneous administration of RVT-1401
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous administration of Placebo
Primary Outcome Measure Information:
Title
Assessment of safety by analysis of adverse events (AEs) data
Time Frame
Weeks 1-18
Title
Change from baseline in levels of total IgG and IgG subclasses (1-4)
Time Frame
Week 7
Title
Change from baseline in levels of anti-AChR-IgG
Time Frame
Week 7
Secondary Outcome Measure Information:
Title
PK Parameters of AUC (0-168 h) after first and last dose
Time Frame
Weeks 1 and 6
Title
PK maximum concentration (Cmax) after first and last dose
Time Frame
Weeks 1 and 6
Title
Concentration of RVT-1401 pre-dose (Ctrough)
Time Frame
Weeks 1-6
Title
Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies
Time Frame
Weeks 1-18
Title
Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score
Time Frame
Week 7
Title
Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by ≥ 3 points from baseline
Time Frame
Week 7
Title
Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Time Frame
Week 7
Title
Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points
Time Frame
Week 7
Title
Change from baseline in the Myasthenia Gravis Composite Score (MGC) score
Time Frame
Week 7
Title
Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by ≥3 points
Time Frame
Week 7
Title
Change from baseline in the Myasthenia Gravis Quality of Life 15 revised Score (MG-QOL 15r) score
Time Frame
Week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 18 years of age. 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. QMG score ≥12 at Screening and Baseline. Other, more specific inclusion criteria are defined in the protocol. Exclusion Criteria: Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening. Thymectomy performed < 12 months prior to screening. Total IgG level <6 g/L (at screening). Absolute neutrophil count <1500 cells/mm3(at screening). Other, more specific exclusion criteria are defined in the protocol
Facility Information:
Facility Name
IMC/Diagnostic and Medical Clinic
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Phoenix Neurological Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
The Neurology Center of Southern California
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
UC Irvine - MDA ALS and Neuromuscular Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Care Access Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Facility Name
CSNA
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Yale School of Medicine Department of Neurology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rare Disease Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
University of Minnesota - Department of Neurology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Dent Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260-1660
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UTSW James W. Aston Ambulatory Care Center - Neurology Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Alberta Hospitals - Division of Pulmonary Medicine
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V4
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
University Health Network Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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