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Monoclonal Antibodies
CNP-106 for Myasthenia Gravis
Phase 1 & 2
Waitlist Available
Research Sponsored by COUR Pharmaceutical Development Company, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of non-childbearing potential (ex. Surgical sterilization, no menses for a year)
Men and non-pregnant women, ages 18-75 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study day 180
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe, effective, and how it works in people for the first time.
Who is the study for?
Adults aged 18-75 with Myasthenia Gravis (MG), experiencing muscle weakness, who have not had certain treatments or surgeries recently. They must have specific MG symptom scores, stable medication doses for 3 months, and agree to use effective birth control. Excludes those with mild or very severe MG, recent strokes, other immune disorders requiring immunosuppressants, significant cardiovascular disease, or a history of certain cancers.Check my eligibility
What is being tested?
The trial is testing CNP-106's safety and effectiveness in treating Myasthenia Gravis compared to a placebo. It's the first time this drug is being given to humans (First-in-Human) and will involve increasing doses to see how patients respond (multiple ascending doses).See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions typical of new medications such as allergic responses, issues at the injection site, general discomfort or changes in blood tests that monitor organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot become pregnant (e.g., due to surgery or menopause).
Select...
I am between 18 and 75 years old and not pregnant.
Select...
My tests show I have anti-AChR antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Change from baseline in activated antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180.
Change from baseline in antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CNP-106Experimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: CNP-106
Group II: PlaceboPlacebo Group2 Interventions
CNP-106 Placebo
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Who is running the clinical trial?
COUR Pharmaceutical Development Company, Inc.Lead Sponsor
4 Previous Clinical Trials
89 Total Patients Enrolled
Roy First, MDStudy ChairCOUR Pharmaceutical
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can subjects aged twenty and older participate in this research trial?
"This research is in search of individuals aged 18 to 75."
Answered by AI
Who is eligible to participate in this research endeavor?
"In order to be eligible for the myasthenia gravis trial, potential participants must fall between 18-75 years of age. The target recruitment size is 54 individuals."
Answered by AI
Are researchers still recruiting participants for this investigation?
"According to clinicaltrials.gov, the recruitment period for this trial closed on October 24th 2023; thus, it is no longer searching for participants. However, there are 89 other medical studies that are still actively looking for more patients."
Answered by AI
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