Clinical trial · Interventional
Myasthenia Gravis Inebilizumab Trial
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
NCT04524273CI-TRIAL-00111761MINTactive not recruitingPhase 3Results postedClinicalTrials.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)
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
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 |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inebilizumab | Drug | — | UNRESOLVED |
| IV Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Inebilizumab, (AChR-Ab+) MG
- description
- Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
- interventionNames
- Drug: inebilizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo, (AChR-Ab+) MG
- description
- Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
- interventionNames
- Drug: IV Placebo
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of MG with anti-AChR or anti-MuSK antibody. 2. MGFA Clinical Classification Class II, III, or IV. 3. MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. 4. QMG score of 11 or greater. 5. Participants must be on: 1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or 2. One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or 3. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid. Exclusion Criteria: 1. Receipt of the following medications within the 4 weeks prior to Day 1: 1. Cyclosporine (except eye drops) 2. Tacrolimus (except topical) 3. Methotrexate 2. Current use of: 1. Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids). 2. Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1. 3. Azathioprine \> 3 mg/kilogram (kg)/day 4. Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day 5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
References
Publications (2)
- DERIVEDNowak RJ, Utsugisawa K, Benatar M, Ciafaloni E, Leite MI, Vissing J, Tang F, Wu Y, Najem C, Cheng S, Howard JF Jr; MINT investigators. Management of Exacerbations and Rescue Therapy: A Prespecified Analysis of the Phase 3 Myasthenia Gravis Inebilizumab Randomized Clinical Trial. JAMA Neurol. 2026 Aug 10. doi: 10.1001/jamaneurol.2026.2558. Online ahead of print. PMID 42573995
- DERIVEDNowak RJ, Benatar M, Ciafaloni E, Howard JF Jr, Leite MI, Utsugisawa K, Vissing J, Rojavin M, Li Q, Tang F, Wu Y, Rampal N, Cheng S; MINT Investigators. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Jun 19;392(23):2309-2320. doi: 10.1056/NEJMoa2501561. Epub 2025 Apr 8. PMID 40202593