Clinical trial · Interventional
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
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
NCT07039916CI-TRIAL-00119989recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMVT-1402 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1: IMVT-1402 Dose 1
- interventionNames
- Drug: IMVT-1402
- type
- EXPERIMENTAL
- label
- Group 2: IMVT-1402 Dose 2
- interventionNames
- Drug: IMVT-1402
- type
- PLACEBO_COMPARATOR
- label
- Placebo/ IMVT-1402
- interventionNames
- Drug: Placebo
- Drug: IMVT-1402
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.