NCT04982289WithdrawnPhase 2
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 · Last updated 11 Feb 2022
Reason given: Sponsor decision to terminate program
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 21 Jun 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Jan 2023
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Diseases
- Myasthenia gravis
- NCT number
- NCT04982289
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening.
- 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).
Other illness
- Any untreated thymic malignancy, carcinoma, or thymoma.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.