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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03863080
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

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
Myasthenia Gravis Drug: RVT-1401 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: Weeks 1-18 ]
  2. Change from baseline in levels of total IgG and IgG subclasses (1-4) [ Time Frame: Week 7 ]
  3. Change from baseline in levels of anti-AChR-IgG [ Time Frame: Week 7 ]

Secondary Outcome Measures :
  1. PK Parameters of AUC (0-168 h) after first and last dose [ Time Frame: Weeks 1 and 6 ]
  2. PK maximum concentration (Cmax) after first and last dose [ Time Frame: Weeks 1 and 6 ]
  3. Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: Weeks 1-6 ]
  4. Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies [ Time Frame: Weeks 1-18 ]
  5. Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score [ Time Frame: Week 7 ]
  6. Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by ≥ 3 points from baseline [ Time Frame: Week 7 ]
  7. Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score [ Time Frame: Week 7 ]
  8. Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points [ Time Frame: Week 7 ]
  9. Change from baseline in the Myasthenia Gravis Composite Score (MGC) score [ Time Frame: Week 7 ]
  10. Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by ≥3 points [ Time Frame: Week 7 ]
  11. Change from baseline in the Myasthenia Gravis Quality of Life 15 revised Score (MG-QOL 15r) score [ Time Frame: Week 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863080


Contacts
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Contact: Central Study Contact 1-800-797-0414 clinicaltrials@immunovant.com

Locations
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Sponsors and Collaborators
Immunovant Sciences GmbH
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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03863080    
Other Study ID Numbers: RVT-1401-2002
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases