Trials / Completed
CompletedNCT03052751
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | UCB7665 | 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) |
| OTHER | Placebo | Placebo will be administered in period 1 of dosage regimen 2. |
Timeline
- Start date
- 2017-05-15
- Primary completion
- 2018-05-31
- Completion
- 2018-08-06
- First posted
- 2017-02-14
- Last updated
- 2021-08-03
- Results posted
- 2021-08-03
Locations
20 sites across 7 countries: United States, Belgium, Canada, Czechia, Denmark, Germany, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03052751. Inclusion in this directory is not an endorsement.