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NCT06517758RECRUITINGIRB Ready

A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 75 Years With gMG.

Sponsored by Novartis Pharmaceuticals

Quick Self-Assessment

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1 of 146 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Adult patients with generalized Myasthenia Gravis (age 18-75 years)
Positive serology testing for AChR+ antibody at screening
Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG and likely not in need v of a respirator for the duration of the study, as judged by the Investigator.
The confirmation of the diagnosis of gMG should be documented and supported by โ‰ฅ1 of the following 3 tests:
History of abnormal neuromuscular transmission demonstrated by single-fiber electromyography or repetitive nerve stimulation.
History of positive edrophonium chloride test
Patient has demonstrated improvement in MG signs on oral acetylcholinesterase inhibitors as assessed by the treating physician.
Baseline MG-ADL score โ‰ฅ6, with โ‰ฅ50% of the total score due to non-ocular symptoms
Participants not optimally controlled for โ‰ฅ 6 months on
just one NSIST; or
two or more NSISTs; or
on frequent (at least quarterly) plasmapheresis, plasma exchange, or intrav

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

146 participants

๐ŸŽ‚

Age Range

18 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Fullerton

California

Location available
View Fullerton location page
RECRUITING

Pasadena

California

Location available
View Pasadena location page
RECRUITING

Sacramento

California

Location available
View Sacramento location page
WITHDRAWN

Boca Raton

Florida

Location available
View Boca Raton location page
WITHDRAWN

Hialeah

Florida

Location available
View Hialeah location page
RECRUITING

Augusta

Georgia

Location available
View Augusta location page
WITHDRAWN

Honolulu

Hawaii

Location available
View Honolulu location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page

๐Ÿ“ And 10 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Myasthenia Gravis Treatment in Scottsdale?

Join others in Arizona exploring innovative treatment options through clinical research

Myasthenia Gravis Treatment Options in Scottsdale, Arizona

If you're searching for Myasthenia Gravis treatment in Scottsdale, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Scottsdale, Fullerton, Pasadena and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myasthenia Gravis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 146 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myasthenia Gravis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Myasthenia Gravis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Myasthenia Gravis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06517758. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.