A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
Rozanolixizumab: Rozanolixizumab will be administered by subcutaneous infusion.
Placebo: Placebo will be administered by subcutaneous infusion.
Study summary
The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.
Eligibility
Primary outcome measure(s)
- Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome (PRO) part) — At Day 43
MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week" ie, the last 7 days.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Mg0038 10104 | Scottsdale | Arizona | Recruiting |
| Mg0038 10105 | O'Fallon | Illinois | Recruiting |
| Mg0038 10106 | Amherst | New York | Recruiting |
| Mg0038 10102 | Cincinnati | Ohio | Recruiting |
| Mg0038 10103 | Columbus | Ohio | Recruiting |
| Mg0038 10108 | Greenfield | Wisconsin | Recruiting |
| Mg0038 10201 | Montreal | Canada | Recruiting |
| Mg0038 31901 | Beijing | China | Recruiting |
| Mg0038 31911 | Beijing | China | Recruiting |
| Mg0038 31912 | Beijing | China | Recruiting |
| Mg0038 31906 | Chengdu | China | Recruiting |
| Mg0038 31908 | Chongqing | China | Recruiting |
| Mg0038 31907 | Nanchang | China | Recruiting |
| Mg0038 31902 | Suzhou | China | Recruiting |
| Mg0038 20303 | Dijon | France | Recruiting |
| Mg0038 20304 | Nantes | France | Recruiting |
| Mg0038 20301 | Nice | France | Recruiting |
| Mg0038 20302 | Paris | France | Recruiting |
| Mg0038 20305 | Paris | France | Recruiting |
| Mg0038 21403 | Sarajishvili | Georgia | Recruiting |
| Mg0038 21402 | Tbilisi | Georgia | Recruiting |
| Mg0038 20405 | Rüdersdorf | Germany | Recruiting |
| Mg0038 31802 | Kobe | Japan | Recruiting |
| Mg0038 31804 | Minatoku | Japan | Recruiting |
| Mg0038 31805 | Sendai | Japan | Recruiting |
| Mg0038 21204 | Katowice | Poland | Recruiting |
| Mg0038 21203 | Krakow | Poland | Recruiting |
| Mg0038 21206 | Lublin | Poland | Recruiting |
| Mg0038 21202 | Warsaw | Poland | Recruiting |
| Mg0038 20605 | Alicante | Spain | Recruiting |
| Mg0038 20604 | Barcelona | Spain | Recruiting |
| Mg0038 20607 | Barcelona | Spain | Recruiting |
| Mg0038 20611 | Madrid | Spain | Recruiting |
| Mg0038 20606 | Málaga | Spain | Recruiting |
| Mg0038 20602 | Murcia | Spain | Recruiting |
| Mg0038 20603 | Seville | Spain | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07463521 on ClinicalTrials.gov ↗ ← All trials in the USA