Subcutaneous Zilucoplan for Myasthenia Gravis

Palo Alto (17 mi)

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?The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia gravis (gMG)

Eligibility Criteria

This trial is for people with generalized myasthenia gravis who were previously on IV C5 inhibitors and are willing to switch to subcutaneous Zilucoplan. They should have stable medication doses, be vaccinated against meningococcal disease, not pregnant or breastfeeding, agree to use contraception, and have no recent surgeries or certain medical conditions.

Inclusion Criteria

I have been diagnosed with Myasthenia Gravis, classified as Class II-IVa.

My immunosuppressive therapy has been stable and will remain so for the next 12 weeks.

My corticosteroid dose has been stable and will remain so for the next 12 weeks.

I am willing to change my current IV treatment to a subcutaneous injection.

Exclusion Criteria

My liver condition is stable and does not have serious complications.

I have been treated with rituximab recently or will be during the study.

I haven't taken any experimental drugs recently.

I have been treated with IVIG, SC immunoglobulin, or plasma exchange recently or am on a chronic regimen.

I have had meningococcal disease before.

Treatment Details

The study tests the safety of switching from intravenous C5 inhibitors to a new method using subcutaneous injections of Zilucoplan in patients with generalized myasthenia gravis. It aims to see if this change maintains their muscle strength without causing harm.

1Treatment groups

Experimental Treatment

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

Study participants will be treated with subcutaneous zilucoplan (0.3mg/kg/day)

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

🇺🇸 Approved in United States as Zilbrysq for: