Clinical trial · Interventional
Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis
A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision to terminate program
Summary
Brief summary (as posted)
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (PD), immunogenicity, and efficacy of subcutaneous (SC) ALXN1830 in adults with generalized myasthenia gravis (gMG).
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 |
|---|---|---|---|
| ALXN1830 | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ALXN1830 Dosing Arm 1
- description
- Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks.
- interventionNames
- Drug: ALXN1830
- type
- EXPERIMENTAL
- label
- ALXN1830 Dosing Arm 2
- description
- Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks.
- interventionNames
- Drug: ALXN1830
- type
- EXPERIMENTAL
- label
- ALXN1830 Dosing Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of myasthenia gravis. * Positive serologic test for anti-acetylcholine receptor antibodies. * Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at Screening. * MG-ADL profile must be ≥ 5. * Participants receiving stable treatment with azathioprine; other immunosuppressive therapies. * Total IgG level at Screening ≥ 600 milligrams/deciliter. Key Exclusion Criteria: * History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening. * Any untreated thymic malignancy, carcinoma, or thymoma. * Intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (Day 1). * Use of rituximab within the 3 months (90 days) prior to Screening. * Participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer). * Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
References
Publications (0)
Data not yet available