Phase
Condition
Neuropathy
Sarcopenia
Polymyositis (Inflammatory Muscle Disease)
Treatment
CNP-106
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who are willing and able to provide Institutional Review Board (IRB)approved written informed consent and privacy language as per national regulations.
Men and non-pregnant women, ages 18-75 years inclusive.
Female subjects of childbearing potential must agree not to become pregnant duringthe clinical study, have a negative pregnancy test at Screening Visit, and agree toone of the following:
Use two highly effective forms of birth control starting at initial screeningand continuing throughout the study duration.
Practice abstinence starting at initial screening and continuing throughout thestudy duration.
Subjects with a Myasthenia Gravis Foundation of America Clinical ClassificationClass II-IV.
Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (LabCorpCentral Laboratory Services Inc.).
Subjects with MG-ADL Score ≥6 at Screening and Baseline Visit with ≥50% of the scorederived from non-ocular symptoms.
Subjects with QMG Score ≥11 at Screening and Baseline Visit.
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 thestudy duration unless reviewed and approved by the medical monitor and the siteinvestigator.
Female subjects who agree to not breastfeed starting at initial screening andthroughout the study duration.
Female subjects who agree to not donate ova starting at initial screening andthroughout the study duration.
Male subjects with a spouse or partner of childbearing potential, who themselves andtheir spouse or partner agree to practice an effective form of birth control asdiscussed with the study doctor or study staff starting at Screening and throughoutthe study duration.
Exclusion
Exclusion Criteria:
Subjects with a Myasthenia Gravis Foundation of America Clinical ClassificationClass I or V.
Subjects with a history of cerebrovascular accident in the past 12 months.
Subjects with MG-ADL Score <6 at Screen or Subjects with MG-ADL Score ≥6 at Screenwith ˂50% of the score derived from non-ocular symptoms.
Subjects with QMG Score <11 at Screen.
Subjects may enter the study following the washout periods for medications asdescribed below prior to screening and refrain from usage throughout the study:
Tacrolimus within 6 months
Azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 90days
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 monitorand study site investigator.
Subjects who have used immunoglobulins given SC or IV (SCIg or IVIg) orplasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
Subjects who have had thymectomy or any other thymic surgery performed within 12months prior to Screening.
Subjects with untreated thymic malignancy, carcinoma, or thymoma.
Subjects with a history of untreated tuberculosis, a positive PPD skin test, or apositive QuantiFERON test.
• Subjects with documented evidence of satisfactory TB treatment can be consideredafter review with the medical monitor and documentation of treatment course.
Subjects who have received administration of any live vaccine (other than intranasalInfluenza) within 28 days or subunit vaccine within 14 days prior to Screening orare planning to receive any vaccination throughout the study duration.
Subjects who have received any COVID-19 vaccine within 14 days prior to Screening.Subjects who have received the first dose of any COVID-19 vaccine may not screen forthe study until 14 days following their last dose of the vaccine if applicable.
Subjects with laboratory test results at Screening or prior to study dosing that areoutside the normal limits and considered by the investigator to be clinicallysignificant. Note: Clinically significant laboratory test results at screening thatare related to the condition (MG) are acceptable if all inclusion and no otherexclusion criteria are met.
Subjects with positive test results for hepatitis B surface antigen (HbsAg),hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)antigen/antibody as determined at Screening.
Subjects with a history of or currently active immune disorders other than MG (including autoimmune disease) unless the condition, after discussion with themedical monitor and study site investigator, has been deemed to be acceptable forthe subject's participation in this clinical study.
Subjects with a history of or current active diseases other than myasthenia gravisrequiring immunosuppressive drugs (including azathioprine, prednisone, prednisolone,budesonide, cyclosporine, tacrolimus, methotrexate, or mycophenolate mofetil) unlessthe condition, after discussion with the medical monitor and site investigator, hasbeen deemed to be acceptable for the subject's participation in this clinical study.
Subjects with a clinical history of significant cardiovascular disease as determinedby the Investigator.
Subjects with a complication or medical history of malignancy within the past 5years which, in the investigator's opinion, makes the subject unsuitable for studyparticipation.
Subjects with a history of mast cell activation disease.
Subjects who, in the investigator's opinion, will be unable to adhere to studyprocedures.
Subjects who have received an investigational therapy other than CNP-106 within 28days or 5 half-lives, whichever is longer, prior to Screening.
Subjects with any known active condition which, in the investigator's opinion, makesthe subject unsuitable for study participation.
Known sensitivity to any components of CNP-106 (PLGA, sucrose, mannitol, or sodiumcitrate).
Study Design
Study Description
Connect with a study center
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
Neuromuscular Clinic and Research Center
Phoenix, Arizona 85028
United StatesSite Not Available
Infusion for Health
Brea, California 92835
United StatesSite Not Available
University of California, Irvine
Orange, California 92868
United StatesSite Not Available
University of California, Davis
Sacramento, California 95817
United StatesSite Not Available
Yale University
New Haven, Connecticut 06516
United StatesSite Not Available
Atlantis Research
Miami, Florida 33173
United StatesSite Not Available
Quantix Research, LLC
Miami, Florida 33173
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Insight Hospital and Medical Center
Chicago, Illinois 60608
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Insight Research Institute, Dearborn
Dearborn, Michigan 48126
United StatesSite Not Available
University of Missouri, NextGen Precision Health
Columbia, Missouri 65211
United StatesSite Not Available
Ohio State University Wexner Medical Center
Colombus, Ohio 43221
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available

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