Recruiting
Phase 3

Zilucoplan

Sponsor:

Miriam Freimer

Code:

NCT07215949

Conditions

Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zilucoplan®

Study Details

Brief summary:

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.

Conditions

Generalized Myasthenia Gravis (gMG)

Study ID

NCT07215949

Start date

Jan 20, 2026

Status verified date

Feb, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient determined to have severe MG exacerbation (e.g. bulbar and/or respiratory symptoms requiring hospitalization, neck extension weakness)
  • MGFA class II - IVb
  • Male or female aged ≥18
  • MG-ADL ≥6 in non-ocular domains
  • Serology - AChR antibody positive (or historically available data)
  • If female of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age > 51 years without menses for ≥ 2 years), negative serum pregnancy test at screening
  • Women of child-bearing potential or men with sexual partners of childbearing potential must be willing to use an acceptable method of birth control for the duration of the study and for 40 days after the last dose of study drug therapy. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, intra-uterine device, the contraceptive ring, and or barrier contraception such as condoms with spermicide.
  • Completed or updated meningococcal vaccination or initiated meningococcal vaccination with appropriate antibiotic prophylaxis according to current USPI and ACIP guidelines

Exclusion Criteria:

  • History of meningococcal disease
  • Participants requiring intubation prior to study start.
  • Recent significant infections which could have caused exacerbation e.g. sepsis and wound infections
  • Pregnancy or lactating
  • Recent surgery (<4 weeks). Minor procedures/surgeries allowed at the discretion of the site principal investigator
  • Current use or known failure of C5 inhibitors in the previous 3 months
  • Initiation of plasma exchange or IVIG in the past 4 weeks
  • Participation in concurrent clinical trial with a therapeutic medication
  • Rituximab use in the previous 9 months
  • Any clinically significant condition or illness, which, in the opinion of the PI, would pose a risk to the subject or might confound the study

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zilucoplan

Subcutaneous zilucoplan

Interventions

Zilucoplan®

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.

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 and Locations

Central contacts

Julie Agriesti, MACPR, CCRC

614-293-4098Julie.Agriesti@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Karim Kheniser, CCRP

614-293-6953Karim.Kheniser@osumc.edu

Julie Agriesti, MACPR, CCRC

614-293-4098Julie.Agriesti@osumc.edu

Principal Investigator:

Miriam Freimer, MD

More Information

Sponsor

Miriam Freimer

Last update posted

Aug 28, 2026

Last verified

Feb, 2026

Keywords

  • MG
  • exacerbation
  • zilucoplan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Miriam Freimer on 2026-08-28.