Myasthenia GravisPhase 2NCT03863080
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
A Phase 2 study testing RVT-1401 in people with Myasthenia Gravis, run by Immunovant Sciences GmbH at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- RVT-1401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 21 May 2019to 21 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States15 sites
Dent Institute
Amherst, New York, 14221
Rare Disease Research
Atlanta, Georgia, 30318
University of Buffalo
Buffalo, New York, 14260-1660
The Neurology Center of Southern California
Carlsbad, California, 92011
CSNA
Colorado Springs, Colorado, 80907
UTSW James W. Aston Ambulatory Care Center - Neurology Clinic
Dallas, Texas, 75390
University of Minnesota - Department of Neurology
Minneapolis, Minnesota, 55455
IMC/Diagnostic and Medical Clinic
Mobile, Alabama, 36604
Yale School of Medicine Department of Neurology
New Haven, Connecticut, 06510
Hospital for Special Surgery
New York, New York, 10021
UC Irvine - MDA ALS and Neuromuscular Center
Orange, California, 92868
Neurological Services of Orlando
Orlando, Florida, 32806
Care Access Research
Pasadena, California, 91101
Phoenix Neurological Associates
Phoenix, Arizona, 85018
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212
Canada5 sites
University of Alberta Hospitals - Division of Pulmonary Medicine
Edmonton, Alberta, T6G 2G3
London Health Sciences Centre
London, Ontario, N6G 2V4
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
University Health Network Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
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.
- Conditions
- Myasthenia Gravis
- Being tested
- RVT-1401, Placebo
- Keywords
- IMVT-1401
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-1401Drug
Subcutaneous administration of RVT-1401
PlaceboDrug
Subcutaneous administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) Receives: Drug: RVT-1401 |
| Regimen B | Experimental | RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) Receives: Drug: RVT-1401 |
| Placebo | Placebo comparator | Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) Receives: Drug: RVT-1401; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Measured: Up to Week 18
Open-Label Extension Period: Number of Participants Reporting AEs and SAEs
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Measured: Up to Week 18
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Measured: Up to Week 7
Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs including SBP, DBP, pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Measured: Up to Week 18
Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Measured: Up to Week 7
Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Measured: Up to Week 18
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Measured: Up to Week 7
Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Measured: Up to Week 18
Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG)
Serum samples were collected for the analysis of total immunoglobulin G. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Measured: Baseline (Day 1) and Up to Week 7
Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
Serum samples were collected for the analysis of IgG 1, 2, 3 and 4 levels. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Measured: Baseline (Day 1) and Up to Week 7
Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7
Serum samples were collected for the analysis of Anti-AChR-IgG. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Measured: Baseline (Day 1) and Week 7
Secondary outcomes (15)
Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401
Blood samples were collected for the analysis of Pharmacokinetic parameter AUC (0-168h).
Measured: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8
Open-label Extension Period: AUC0-168h of RVT-1401
Pharmacokinetic parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters.
Measured: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14
Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401
Blood samples were collected for the analysis of Pharmacokinetic parameter Cmax.
Measured: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8
Open-label Extension Period: Cmax of RVT-1401
Blood samples were collected for the analysis of Pharmacokinetic parameter Cmax.
Measured: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14
Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401
Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic RVT-1401.
Measured: Pre-dose
Open-label Extension Period: Ctrough of RVT-1401
Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic RVT-1401.
Measured: Pre-dose
Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score
The QMG score is a physician-reported outcome measure was used to assess MG disease severity and pattern of deficits based on quantitative testing of affected muscle groups. The scale comprised of 13 test items that were graded on a scale of 0 (no myasthenic findings) to 3 (maximal myasthenic deficits). The total sum across all 13 items represents the QMG score. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36) and Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline
The response is defined as improvement from Baseline on the QMG score by => 3 points. The QMG score is a physician-reported outcome measure was used to assess MG disease severity and pattern of deficits based on quantitative testing of affected muscle groups. The scale comprised of 13 test items that were graded on a scale of 0 (no myasthenic findings) to 3 (maximal myasthenic deficits). The total sum across all 13 items represents the QMG score. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
The MG-ADL is an 8-item, participant-reported outcome measure that assessed Myasthenia Gravis symptoms and their effects on activities of daily living, with each response graded from 0 (normal) to 3 (most severe). The MG-ADL score was calculated by totaling the rating for each of the 8 items. Total MG-ADL scores range from 0 to 24 with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the MG-ADL Score
The response was defined as improvement (decrease) from Baseline on the MG-ADL score by => 2 points. The MG-ADL is an 8-item, participant-reported outcome measure that assessed Myasthenia Gravis symptoms and their effects on activities of daily living, with each response graded from 0 (normal) to 3 (most severe). The MG-ADL score was calculated by totaling the rating for each of the 8 items. Total MG-ADL scores range from 0 to 24 with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug.
Measured: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Composite Score (MGC) Score
The MGC was developed by selecting the best performing items from 3 commonly used Myasthenia Gravis specific scales (QMG, Myasthenia Gravis manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and 2 limb items. The total score ranges from 0 (no myasthenic findings) to 50 (maximal myasthenic deficits). The scale measures symptoms and signs of MG in these domains incorporating both physician and participant-reported test items. Higher scores correlate with clinical worsening of the disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement on the MGC Score
The response was defined as improvement (decrease) from Baseline on the MGC score by => 3 points. The MGC was developed by selecting the best performing items from 3 commonly used Myasthenia Gravis specific scales (QMG, Myasthenia Gravis manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and 2 limb items. The total score ranges from 0 (no myasthenic findings) to 50 (maximal myasthenic deficits). The scale measures symptoms and signs of MG in these domains incorporating both physician and participant-reported test items. Higher scores correlate with clinical worsening of the disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug.
Measured: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Quality of Life 15 Revised Score (MG-QOL 15r) Score
The MG-QOL15r is a participant-reported questionnaire designed to assess how a participant's Myasthenia Gravis affects different aspects related to their quality of life. The scale includes 15 items that are graded on a scale of 0 to2; the total across is the sum of all 15 items and represents the MG-QOL15r score. The range of the MG-QOL15r score is 0 - 30. Higher scores indicate worse outcomes. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1) and at Week 4 and Week 7
Double-Blind Treatment Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies
The serum levels of anti-RVT-1401 antibodies were determined. All samples that were potentially positive were analyzed with the confirmation assay where presence of anti-RVT-1401 was confirmed; the therapeutic antibody was used to compete with the analytical responses of anti-drug antibody (ADA) to assess specificity of screened positive samples.
Measured: Up to Week 7
Open-Label Extension Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies
The serum levels of anti-RVT-1401 antibodies were determined. All samples that were potentially positive were analyzed with the confirmation assay where presence of anti-RVT-1401 was confirmed; the therapeutic antibody was used to compete with the analytical responses of ADA to assess specificity of screened positive samples.
Measured: Up to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start21 May 2019
- Primary completion7 Oct 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863080
- Sponsor's protocol ID
- RVT-1401-2002
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2019
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
- ClinicalTrials.gov ID
- NCT03863080
- Acronym / sponsor ID
- RVT-1401-2002
- Conditions
- Myasthenia Gravis
- Keywords
- IMVT-1401
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: RVT-1401RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Regimen B | Experimental | Drug: RVT-1401RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Placebo | Placebo comparator | Drug: RVT-1401, Drug: PlaceboPlacebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVT-1401Subcutaneous administration of RVT-1401 | Drug | Placebo, Regimen A, Regimen B |
| PlaceboSubcutaneous administration of Placebo | Drug | Placebo |
Primary outcome
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 18
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Open-Label Extension Period: Number of Participants Reporting AEs and SAEs
Time frame: Up to Week 18
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to Week 7
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to Week 18
Vital signs including SBP, DBP, pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to Week 7
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to Week 18
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Time frame: Up to Week 7
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG
Time frame: Up to Week 18
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG)
Time frame: Baseline (Day 1) and Up to Week 7
Serum samples were collected for the analysis of total immunoglobulin G. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
Time frame: Baseline (Day 1) and Up to Week 7
Serum samples were collected for the analysis of IgG 1, 2, 3 and 4 levels. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7
Time frame: Baseline (Day 1) and Week 7
Serum samples were collected for the analysis of Anti-AChR-IgG. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
15 secondary outcomes
Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401
Time frame: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8
Open-label Extension Period: AUC0-168h of RVT-1401
Time frame: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14
Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401
Time frame: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8
Open-label Extension Period: Cmax of RVT-1401
Time frame: Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14
Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401
Time frame: Pre-dose
Open-label Extension Period: Ctrough of RVT-1401
Time frame: Pre-dose
Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score
Time frame: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36) and Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline
Time frame: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
Time frame: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the MG-ADL Score
Time frame: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Composite Score (MGC) Score
Time frame: Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7
Double-Blind Treatment Period: Percentage of Participants With an Improvement on the MGC Score
Time frame: Baseline (Day 1) to Week 7
Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Quality of Life 15 Revised Score (MG-QOL 15r) Score
Time frame: Baseline (Day 1) and at Week 4 and Week 7
Double-Blind Treatment Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies
Time frame: Up to Week 7
Open-Label Extension Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies
Time frame: Up to Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVT-1401 in people with Myasthenia Gravis, run by Immunovant Sciences GmbH at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Week 18). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.