A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06517758
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Iptacopan — DRUG
    Hard gelatin capsule
  • Matching Placebo — OTHER
    Hard gelatin capsule

Study Details

The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region.

Key Dates

First listed
Jul 24, 2024
Start date
Jul 31, 2024
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
May 27, 2032

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan
    Iptacopan orally for 6 months (double-blind) followed by open-label iptacopan for up to 60 months
  • Placebo Comparator: Matching Placebo
    Placebo orally for 6 months (double-blind) followed by open-label iptacopan for up to 60 months

Primary Outcome Measure

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score [ Time Frame: Baseline to Month 6 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
Fullerton Neuro and Headache CtrFullertonCalifornia92835-
California Pacific Medical CenterSacramentoCalifornia94115-
Augusta University GeorgiaAugustaGeorgia30912-
University of Chicago Medical CentrChicagoIllinois60637-
Prairie Heart InstituteSpringfieldIllinois62769-
Mid Atlantic Epilepsy and Sleep CtrBethesdaMaryland20817-1807-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Duke University Medical CenterDurhamNorth Carolina27710-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
Vanderbilt University Medical CenterXNashvilleTennessee37221-
Nerve and Muscle Center of TexasHoustonTexas77030-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZFullerton Neuro and Headache Ctr· Fullerton, CACalifornia Pacific Medical Center· Sacramento, CAAugusta University Georgia· Augusta, GAUniversity of Chicago Medical Centr· Chicago, ILPrairie Heart Institute· Springfield, IL

Related Studies