Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
Led by COUR Pharmaceutical Development Company, Inc. · Updated on 2025-02-13
54
Participants Needed
17
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Men and non-pregnant women aged 18 to 75 years
- Female subjects of childbearing potential must agree to effective birth control or abstinence during the study
- Diagnosed with Myasthenia Gravis Foundation of America Clinical Classification Class III-IV (Cohort 1) or Class II-IV (Cohort 2)
- Positive for anti-AChR antibodies by radioimmunoassay
- MG-ADL Score of 6 or higher at screening and baseline with at least 50% from non-ocular symptoms
- QMG Score of 11 or higher at screening and baseline
- Stable dose of MG symptom medications for at least 90 days prior to enrollment
- Female subjects agree not to breastfeed during the study
- Female subjects agree not to donate ova during the study
- Male subjects with partners of childbearing potential agree to use birth control during the study
You will not qualify if you...
- Myasthenia Gravis Foundation of America Clinical Classification Class I or V
- History of stroke in the past 12 months
- MG-ADL Score below 6 at screening or less than 50% non-ocular symptoms if 6 or higher
- QMG Score below 11 at screening
- Use of certain immunosuppressive or immunomodulatory medications recently (e.g., Tacrolimus, Methotrexate, Anti-FcRn inhibitors, C5 complement inhibitors, Anti-CD20 agents)
- Use of immunoglobulins or plasmapheresis within 4 weeks before screening
- Thymectomy or thymic surgery within 12 months before screening
- Untreated thymic malignancy or thymoma
- History of tuberculosis or positive PPD skin test
- Recent live or subunit vaccines or COVID-19 vaccination within specified time frames
- Clinically significant abnormal lab tests not related to MG
- Positive tests for hepatitis B, hepatitis C, or HIV
- Other active immune disorders or diseases requiring immunosuppressive drugs unless approved
- Significant cardiovascular disease
- History or current malignancy within past 5 years making participation unsuitable
- History of mast cell activation disease
- Unable to adhere to study procedures
- Recent investigational therapy other than CNP-106
- Any other active condition making participation unsuitable
- Known sensitivity to CNP-106 components (PLGA, sucrose, mannitol, sodium citrate)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Neuromuscular Clinic and Research Center
Phoenix, Arizona, United States, 85028
Not Yet Recruiting
3
Infusion for Health
Brea, California, United States, 92835
Actively Recruiting
4
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06516
Actively Recruiting
6
Atlantis Research
Miami, Florida, United States, 33173
Actively Recruiting
7
Quantix Research, LLC
Miami, Florida, United States, 33173
Actively Recruiting
8
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
9
Insight Hospital and Medical Center
Chicago, Illinois, United States, 60608
Actively Recruiting
10
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
11
Insight Research Institute, Dearborn
Dearborn, Michigan, United States, 48126
Actively Recruiting
12
University of Missouri, NextGen Precision Health
Columbia, Missouri, United States, 65211
Actively Recruiting
13
Ohio State University Wexner Medical Center
Colombus, Ohio, United States, 43221
Not Yet Recruiting
14
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
15
Nerve and Muscle Center of Texas
Houston, Texas, United States, 77030
Actively Recruiting
16
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
17
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Not Yet Recruiting
Research Team
J
Joseph Mide
CONTACT
H
Harold Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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