A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis

Last updated: February 14, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

Zilucoplan

Clinical Study ID

NCT06471361
DV0013
U1111-1302-4369
2023-508287-30
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participant is male or female and must be at least 18 years of age at the timeof signing the informed consent form (ICF).

  • Study participant must have a documented diagnosis of gMG, based on studyparticipant's history and supported by previous evaluations.

  • Study participant is currently participating in ZLP (zilucoplan) studyRA101495-02.302 (NCT04225871) or is administering commercial ZLP on a stable dosingregimen for at least 1 month prior to Screening.

  • Study participants on commercial ZLP need to receive ZLP per the approved locallabeling.

  • Study participant is considered reliable and capable of adhering to the studyprotocol (eg, able to understand and complete questionnaires and able to adhere tothe visit schedule) according to the judgement of the Investigator.

  • Study participant is willing and capable of self-administering ZLP using thezilucoplan-auto-injector (ZLP AI) according to the instructions for use (IFU), ie,does not have any visual, physical, or other disability or impairment thatinterferes with his/her capacity to self-administer; if the participant has acaregiver, he/she may assist the participant with the injection.

  • Vaccination with a quadrivalent meningococcal vaccine and, where available,meningococcal serotype B vaccine at least 14 days prior to investigational medicinalproduct (IMP) administration, if not vaccinated within 3 years prior to the start oftreatment. Booster vaccination(s) should also be administered as clinicallyindicated, according to the local standard of care, for participants who have beenpreviously vaccinated against Neisseria meningitidis.

  • Female participants of childbearing potential must have a negative urine pregnancytest prior to the first dose of study drug.

  • Male and/or female study participants

  1. A male participant must agree to use contraception during the Treatment Periodand for 40 days after the last dose of study medication, and refrain fromdonating sperm during this period.

  2. A female participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies:

  • Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow thecontraceptive guidance the Treatment Period and for 40 days after the last dose ofstudy medication.

  • Capable of giving signed informed which includes compliance with the requirementsand restrictions listed in the ICF and in this protocol.

Exclusion

Exclusion Criteria:

  • Study participant has any medical or psychiatric condition that, in the opinion ofthe Investigator, could jeopardize or would compromise the study participant'sability to participate in this study.

  • Female participants who are breastfeeding, pregnant, or plan to become pregnantduring the study.

  • Study participant has a known hypersensitivity to any components of the studymedication (and/or an investigational device) as stated in this protocol.

  • Study participant has a clinically relevant active infection or a history of seriousinfection (resulting in hospitalization or requiring intravenous antibiotictreatment) within 6 weeks before Visit 1.

  • Study participant has a history of meningococcal disease.

  • Participant has previously participated in this study or participant has previouslybeen assigned to treatment in a study of the medication under investigation in thisstudy (except studies RA101495-02.201 (NCT03315130), RA101495-02.301 (NCT04115293),or RA101495-02.302 (NCT04225871), which are not excluded, unless the participant wasrequired to withdraw from said studies for a safety reason which could reasonablyrecur).

  • Participant has participated in another study of an IMP (and/or an investigationaldevice) different from ZLP within the previous 3 months or 5 half-lives, whicheveris longer, or is currently participating in another study of an IMP (and/or aninvestigational device).

  • Current unstable liver or biliary disease at Screening (Visit 1), per Investigatorassessment, defined by the presence of ascites, encephalopathy, coagulopathy,hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.NOTE: with exception of stable hepatobiliary conditions (including Gilbert'ssyndrome, asymptomatic gallstones).

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Zilucoplan
Phase: 3
Study Start date:
August 27, 2024
Estimated Completion Date:
February 03, 2025

Connect with a study center

  • Dv0013 40609

    Katowice,
    Poland

    Site Not Available

  • Dv0013 40759

    Kraków,
    Poland

    Site Not Available

  • Dv0013 40605

    Poznan,
    Poland

    Site Not Available

  • Dv0013 40760

    Oxford,
    United Kingdom

    Site Not Available

  • Dv0013 50628

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Dv0013 50634

    Tampa, Florida 33612
    United States

    Site Not Available

  • Dv0013 50648

    Columbia, Missouri 64212
    United States

    Site Not Available

  • Dv0013 50556

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Dv0013 50635

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Dv0013 50555

    Austin, Texas 78759
    United States

    Site Not Available

  • Dv0013 50636

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

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