At a glance
ClinicalIndex Comparison Record- ✓Confirmed myasthenia gravis diagnosis with documented history
- ✓Candidate for immunological therapy (IVIG or plasma exchange) per investigator
- ✓Seropositive: documented anti-AChR or anti-MuSK autoantibodies prior to screening
- ✕Ocular myasthenia gravis only (generalized disease required)
- ✕Severe oropharyngeal or respiratory weakness, myasthenic crisis, or impending crisis
- ✕QMG score <11 at baseline (indicates mild disease)
- ✕Serum total IgG ≤6 g/L at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
In Brief
A Phase 2 clinical trial evaluating UCB7665 and Placebo for Myasthenia Gravis. Completed, enrolled 43 participants across 20 sites in 7 countries.
Detailed Summary
The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.
Study Details
Timeline
Interventions
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)
Placebo will be administered in period 1 of dosage regimen 2.