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CNP-106 for Myasthenia Gravis

This study is testing a new treatment called CNP-106 for people with Myasthenia Gravis (MG), a condition that causes muscle weakness. Researchers want to see if CNP-106 is safe, how well your body tolerates it, and if it helps improve MG symptoms. They are also looking at how the drug works in your body. CNP-106 is made of tiny particles containing parts of a protein called AChR, which is involved in MG. Some participants will receive CNP-106, while others will receive a placebo (an inactive substance). The main goal is to track any side effects. You may be able to join if you are 18 to 75 years old and have generalized MG. The study is currently unclear on its recruitment status and plans to enroll 54 participants.

Study design
This is a Phase 1b/2a study, which means it's an early-stage trial looking at safety and initial effectiveness. It will involve about 54 participants.
What's involved
You would be screened for up to 42 days before potentially joining the study, which then lasts for 180 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored through study day 180.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06106672

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
COUR Pharmaceutical Development Company, Inc.
~54 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:CNP-106Placebo

At a glance

Recruiting sites
0 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs),
Measured over Through study day 180

Conditions

Myasthenia Gravis
Generalized Myasthenia
AChR Myasthenia Gravis
MuSK MG

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Where it's being run

17 sites across 12 states
California3
Florida3
Texas2
Arizona1
Connecticut1
Illinois1
Kansas1
Michigan1

Study leadership

  • Paul Peloso, MD · STUDY_CHAIR · COUR Pharmaceutical

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Use two highly effective forms of birth control starting at initial screening and continuing throughout the study duration.
Practice abstinence starting at initial screening and continuing throughout the study duration. 4. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class II-IV. 5. Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (LabCorp Central Laboratory Services Inc.). 6. Subjects with MG-ADL Score ≥6 at Screening and Baseline Visit with ≥50% of the score derived from non-ocular symptoms. 7. Subjects with QMG Score ≥11 at Screening and Baseline Visit. 8. For subjects on any medication used to treat the symptoms of MG (e.g. Corticosteroids, pyridostigmine), subjects must be on a stable dose for a minimum of 90 days prior to enrollment and must agree not to increase their dose throughout the study duration unless reviewed and approved by the medical monitor and the site investigator. 9. Female subjects who agree to not breastfeed starting at initial screening and throughout the study duration. 10. Female subjects who agree to not donate ova starting at initial screening and throughout the study duration. 11. Male subjects with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the study duration.

Exclusion

Tacrolimus within 6 months
Azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 90 days
Anti-FcRn therapies:
Cyclic Anti-FcRns (e.g., efgartigimod alfa, rozanolixizumab) within 50 days
Chronic Anti-FcRns (e.g., nipocalimab) within 80 days;
C5 complement inhibitor (e.g., eculizumab) within 90 days
Anti-CD20 (e.g., rituximab) within 6 months;
Other immunomodulatory drugs will be at the discretion of the medical monitor and study site investigator. 6. Subjects who have used immunoglobulins given SC or IV (SCIg or IVIg) or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening. 7. Subjects who have had thymectomy or any other thymic surgery performed within 12 months prior to Screening. 8. Subjects with untreated thymic malignancy, carcinoma, or thymoma. 9. Subjects with a history of untreated tuberculosis, a positive PPD skin test, or a positive QuantiFERON test.

What this trial measures

  • Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs),Through study day 180

    Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to COUR Pharmaceuticals Development Company, Inc. Confidential CNP-106-5.001 Protocol; IND 28774 Page 53 of 65 discontinuation from IP and study, by severity, and by causality. No formal statistical testing will be done.