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
Recruiting
Apply to this trial

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

Start date
Jul 31, 2024
Status verified
May 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 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (21)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258
Kristy Osgood
[email protected]
Suraj Muley (PRINCIPAL_INVESTIGATOR)
Fullerton Neuro and Headache CtrFullertonCalifornia92835
Alexandra Vasquez
[email protected]
714-738-0800
Jack H Florin (PRINCIPAL_INVESTIGATOR)
SC3 Research PasadenaPasadenaCalifornia91105
Charles Krinel
[email protected]
M Lorraine Purino (PRINCIPAL_INVESTIGATOR)
California Pacific Medical CenterSacramentoCalifornia94115
415-600-3604
Liberty Jenkins (PRINCIPAL_INVESTIGATOR)
Neurology Offices Of South FloridaBoca RatonFlorida33428-
Superior Associates in Research LLCHialeahFlorida33012-
Augusta University GeorgiaAugustaGeorgia30912
Christian Ryan
[email protected]
706-721-6411
Benjamin Barnes (PRINCIPAL_INVESTIGATOR)
Hawaii Pacific Neuroscience LLCHonoluluHawaii96817-
University of Chicago Medical CentrChicagoIllinois60637
Deekshitha Turaka
[email protected]
773-702-6222
Kourosh Rezania (PRINCIPAL_INVESTIGATOR)
Prairie Heart InstituteSpringfieldIllinois62769
Megan Kaler
[email protected]
217-492-9100
Raghav Govindarajan (PRINCIPAL_INVESTIGATOR)
Mid Atlantic Epilepsy and Sleep CtrBethesdaMaryland20817-1807
Jonathan Ross (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amanda Guidon (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
313-916-6781
Kavita Grover (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Kinjal Patel
[email protected]
Shruti Raja (PRINCIPAL_INVESTIGATOR)
Neuroscience Research CtrCantonOhio44718-
Ohio State University Medical CenterColumbusOhio43210-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
Thomas Keenan
[email protected]
215-662-8570
Sami Khella (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterXNashvilleTennessee37221
Amanda Peltier (PRINCIPAL_INVESTIGATOR)
Nerve and Muscle Center of TexasHoustonTexas77030
Aziz Shaibani. (PRINCIPAL_INVESTIGATOR)
Central TX Neuro Consultants P ARound RockTexas78681-
Center for Neurological Disorders GGreenfieldWisconsin53228-1321
Emily Barraza
[email protected]
414-214-7275
Bhupendra Khatri (PRINCIPAL_INVESTIGATOR)

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