Zilucoplan for Myasthenia Gravis
(RAISE-XT Trial)

Recruiting in Palo Alto (17 mi)

+144 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing zilucoplan, a medication for muscle weakness, in patients with generalized Myasthenia Gravis who were in previous studies. It aims to see if the drug is safe and effective over time by calming the immune system to prevent it from attacking muscles. Zilucoplan is currently being tested for its potential to improve disease control in generalized myasthenia gravis.

Eligibility Criteria

This trial is for individuals with generalized Myasthenia Gravis (gMG) who have already completed a qualifying study involving zilucoplan. They should not be part of any other clinical trials testing new treatments, although observational studies are okay.

Inclusion Criteria

You have participated in a previous study involving zilucoplan.

Exclusion Criteria

With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)

Treatment Details

Interventions

Zilucoplan (Monoclonal Antibodies)

Trial OverviewThe RAISE-XT study is testing the long-term effects of zilucoplan on people with gMG. It's an open-label extension, meaning everyone knows they're getting zilucoplan and there's no placebo comparison.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 0.3 mg/kg zilucoplan (RA101495)Experimental Treatment1 Intervention

Zilucoplan is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Zilbrysq for: