Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMVT-1402, IMVT-1402, Placebo, IMVT-1402.
- Who it may be relevant to
- Registry conditions: Generalized Myasthenia Gravis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Czechia, Denmark, Georgia +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Overview
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Interventions
- Drug IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1) - Drug IMVT-1402
* Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3) - Drug Placebo
• Placebo SC QW for 12 weeks (Period 1) - Drug IMVT-1402
* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
Primary outcome measures
- Change from Baseline in MG-ADL Score for Antibody-positive Participants [Time frame: Baseline to Week 12]
Secondary outcome measures (3)
- Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants [Time frame: Baseline to Week 12]
- Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1 [Time frame: Week 12]
- Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score [Time frame: Baseline to Week 12]
Eligibility criteria
Inclusion criteria
- Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit
- Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)
Additional inclusion criteria are defined in the protocol.
Exclusion criteria
- Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.
- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study
- Have any active or untreated malignant thymoma
Additional exclusion criteria are defined in the protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 48 centers
- Site Number - 1056 — Huntsville
- Site Number - 1041 — Mobile
- Site Number - 1017 — Phoenix
- Site Number - 1025 — Scottsdale
- Site Number - 1042 — Tucson
- Site Number - 1010 — Carlsbad
- Site Number - 1028 — Irvine
- Site Number - 1023 — Los Angeles
- … and 40 more centers
Poland · 7 centers
- Site Number - 3005 — Gdansk
- Site Number - 3001 — Katowice
- Site Number - 3006 — Krakow
- Site Number - 3002 — Krakow
- Site Number - 3003 — Krakow
- Site Number - 3004 — Lublin
- Site Number - 3007 — Warsaw
Germany · 4 centers
- Site Number - 6502 — Bochum
- Site Number - 6504 — Goettigen
- Site Number - 6505 — Magdeburg
- Site Number - 6503 — Würzburg
Greece · 4 centers
- Site Number - 3903 — Athens
- Site Number - 3902 — Athens
- Site Number - 3901 — Pátrai
- Site Number - 3904 — Thessaloniki
Italy · 4 centers
- Site Number - 6003 — Bergamo
- Site Number - 6002 — Milan
- Site Number - 6001 — Naples
- Site Number - 6004 — Rome
Georgia · 3 centers
- Site Number - 8002 — Tbilisi
- Site Number - 8003 — Tbilisi
- Site Number - 8001 — Tbilisi
Hungary · 3 centers
- Site Number - 7552 — Budapest
- Site Number - 7553 — Budapest
- Site Number - 7551 — Kistarcsa
Spain · 3 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Argentina · 2 centers
- Site Number - 5003 — Caba
- Site Number - 5002 — Rosario
Romania · 2 centers
- Site Number - 7502 — Constanța
- Site Number - 7501 — Târgu Mureş
Serbia · 2 centers
Center list to be confirmed — check the primary protocol.
Czechia · 1 center
- Site Number - 3201 — Brno
Denmark · 1 center
- Site Number - 3601 — Copenhagen
Mexico · 1 center
- Site Number - 2602 — Mexico City
Identifiers
NCT: NCT07039916 · IMVT-1402-3101 · 2024-515979-35-00