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NCT03971422 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT03971422: Completed Phase 3 study of Generalized Myasthenia Gravis, sponsored by UCB Biopharma SRL.
NCT03971422 is a Phase 3 study of Generalized Myasthenia Gravis that has completed, run by UCB Biopharma SRL. The registered enrollment target is 200 participants, above the 123-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (63% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971422, a Phase 3 study of Generalized Myasthenia Gravis, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
Primary Outcome
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or imp
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Rozanolixizumab
Study Locations (20)
California
- Mg0003 50072 - Los Angeles
- Mg0003 50092 - Orange
- Mg0003 50097 - San Francisco
- Mg0003 50099 - San Francisco
Florida
- Mg0003 50122 - Miami
- Mg0003 50120 - Miami
- Mg0003 50073 - Tampa
Arizona
- Mg0003 50081 - Phoenix
- Mg0003 50082 - Scottsdale
Michigan
- Mg0003 50110 - Ann Arbor
- Mg0003 50102 - Detroit
Colorado
- Mg0003 50101 - Aurora
District of Columbia
- Mg0003 50088 - Washington D.C.
Georgia
- Mg0003 50075 - Augusta
Hawaii
- Mg0003 50323 - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 3 |
What the finished NCT03971422 record still lists
NCT03971422 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (63% higher).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03971422 names 20 study sites across 13 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03971422 about?
NCT03971422 is a clinical study titled "A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis". The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
What is the current status of trial NCT03971422?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2019-06-03. Estimated completion is 2021-10-26.
What conditions does trial NCT03971422 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT03971422?
The interventions under investigation include: Placebo (OTHER), Rozanolixizumab (DRUG).
Who is sponsoring clinical trial NCT03971422?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03971422 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Generalized Myasthenia Gravis
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Where NCT03971422's enrollment target sits among peer trials
200 7th of 26 higher than 19 of 26 other Generalized Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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