Zilucoplan for Severe gMG Exacerbations

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Miriam Freimer
Study ID
NCT07215949
Phase
PHASE3
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zilucoplan® — DRUG
    Subcutaneous injections of zilucoplan will be administered daily. The dose is dependent on the body weight of the patient. Each patient will receive a kit with prefilled syringes.

Study Details

This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive subcutaneous zilucoplan injections daily for 12 weeks. Participation in the study will last for approximately 18 weeks.

Key Dates

Start date
Jan 20, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zilucoplan
    Subcutaneous zilucoplan

Primary Outcome Measure

Change from baseline to Week 2 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score [ Time Frame: From baseline to Week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Karim Kheniser, CCRP
[email protected]
614-293-6953
Julie Agriesti, MACPR, CCRC
[email protected]
614-293-4098
Miriam Freimer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Ohio State University· Columbus, OH

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