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

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ClinicalTrials.gov Identifier: NCT03863080
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE March 5, 2019
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: Weeks 1-18 ]
  • Change from baseline in levels of total IgG and IgG subclasses (1-4) [ Time Frame: Week 7 ]
  • Change from baseline in levels of anti-AChR-IgG [ Time Frame: Week 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: Week 7 ]
    Subjects will be summarized by actual treatment received for analyses based the number and percentage of subjects in each treatment group. AE summaries by study part and treatment group, of the number and percent of participants reporting each event at least once will be generated.Other safety data will be summarized descriptively by treatment and time.
  • Assessment of tolerability by subject disposition [ Time Frame: Week 7 ]
    A summary of subject disposition will be provided by treatment group. This summary will present the number of subjects screened, randomized, included in each analysis population, and the number and percent of subject in each category.
  • Percentage change from baseline in levels of total IgG and IgG subclasses (1-4) [ Time Frame: Week 7 ]
  • Percentage change from baseline in levels of anti-AChR-IgG [ Time Frame: Week 7 ]
Change History Complete list of historical versions of study NCT03863080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • PK Parameters of AUC (0-168 h) after first and last dose [ Time Frame: Weeks 1 and 6 ]
  • PK maximum concentration (Cmax) after first and last dose [ Time Frame: Weeks 1 and 6 ]
  • Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: Weeks 1-6 ]
  • Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies [ Time Frame: Weeks 1-18 ]
  • Change from baseline in the Quantitative Myasthenia Gravis Score (QMG) 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 ]
  • Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score [ Time Frame: Week 7 ]
  • Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points [ Time Frame: Week 7 ]
  • Change from baseline in the Myasthenia Gravis Composite Score (MGC) score [ 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 Quality of Life 15 revised Score (MG-QOL 15r) score [ Time Frame: Week 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • PK Parameters of AUC (0-168 h) after first and last dose [ Time Frame: Week 7 ]
  • PK maximum concentration (Cmax) after first and last dose [ Time Frame: Week 7 ]
  • Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: Week 7 ]
  • Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies [ Time Frame: Week 7 ]
    Anti-RVT-1401 antibody titers will be determined in serum samples using the currently approved bioanalytical methodology. Raw data will be archived at the bioanalytical site. If Anti-RVT-1401 antibody titers are detected, they will be further characterized using a validated cell based Nab assay
  • Percentage change from baseline in the Quantitative Myasthenia Gravis Score (QMG) Score [ Time Frame: Week 7 ]
    The QMG score was developed as a tool to assess MG disease severity and the pattern of deficits based on quantitative testing of affected muscle groups. The scale is comprised of 13 test items that are graded on a scale of 0-3. The total sum across all 13 items represents the QMG Score. The test takes approximately 30 minutes to perform.
  • Proportion of participants with an improvement on the Quantitative Myasthenia Gravis Score (QMG) score by ≥ 3 points from baseline [ Time Frame: Week 7 ]
    The QMG score was developed as a tool to assess MG disease severity and the pattern of deficits based on quantitative testing of affected muscle groups. The scale is comprised of 13 test items that are graded on a scale of 0-3. The total sum across all 13 items represents the QMG Score. The test takes approximately 30 minutes to perform.
  • Percentage change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score [ Time Frame: Week 7 ]
    The MG-ADL is an 8-item, patient reported questionnaire that assesses MG symptoms and their effects on activities of daily living. The scale has been validated and shown to correlate with the QMG scale and newer MG outcome scales such as the MGC and MG-QOL15r. Participants are asked to rate each item on a scale of 0-3. The MG-ADL score is calculated by totaling the rating for each of the 8 items. The scale takes approximately 2-3 min to complete.
  • Proportion of participants with an improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score by ≥2 points [ Time Frame: Week 7 ]
    The MG-ADL is an 8-item, patient reported questionnaire that assesses MG symptoms and their effects on activities of daily living. The scale has been validated and shown to correlate with the QMG scale and newer MG outcome scales such as the MGC and MG-QOL15r. Participants are asked to rate each item on a scale of 0-3. The MG-ADL score is calculated by totaling the rating for each of the 8 items. The scale takes approximately 2-3 min to complete.
  • Percentage change from baseline in the Myasthenia Gravis Composite Score (MGC) score [ Time Frame: Week 7 ]
    The MGC was developed by selecting the best performing items from 3 commonly used MG-specific scales (QMG, MG manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and two limb items. The scale measures symptoms and signs of MG in these domains incorporating both physician and patient-reported test items. The MGC takes approximately 5 min to complete.
  • Proportion of participants with an improvement on the Myasthenia Gravis Composite Score (MGC) Score by ≥3 points [ Time Frame: Week 7 ]
    The MGC was developed by selecting the best performing items from 3 commonly used MG-specific scales (QMG, MG manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and two limb items. The scale measures symptoms and signs of MG in these domains incorporating both physician and patient-reported test items. The MGC takes approximately 5 min to complete.
  • Percentage change from baseline in the Myasthenia Gravis Quality of Life 15 revised Score (MG-QOL 15r) score [ Time Frame: Week 7 ]
    The MG-QOL15r is a patient-reported scale designed to assess how their MG affects different aspects related to quality of life. There are 15 items that are graded on a scale of 0-2; the total across all 15 items represents the MG-QOL15r score. The survey takes approximately 2 minutes to complete by the participant.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Official Title  ICMJE A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Myasthenia Gravis
Intervention  ICMJE
  • Drug: RVT-1401
    Subcutaneous administration of RVT-1401
  • Drug: Placebo
    Subcutaneous administration of Placebo
Study Arms  ICMJE
  • 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)
    Intervention: Drug: 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)
    Intervention: Drug: RVT-1401
  • Placebo Comparator: Placebo
    Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
    Interventions:
    • Drug: RVT-1401
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Central Study Contact 1-800-797-0414 clinicaltrials@immunovant.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03863080
Other Study ID Numbers  ICMJE RVT-1401-2002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunovant Sciences GmbH
Study Sponsor  ICMJE Immunovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immunovant Sciences GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP