CM-101 for Primary Sclerosing Cholangitis
Trial Summary
What is the purpose of this trial?
This trial tests a new antibody treatment for adults with Primary Sclerosing Cholangitis (PSC). The treatment aims to block a molecule that causes inflammation, potentially reducing liver damage.
Will I have to stop taking my current medications?
The trial requires that participants stay on a stable dose of their current medications for Primary Sclerosing Cholangitis (PSC) and inflammatory bowel disease (IBD) for at least 12 weeks before joining the study and continue on that stable dose during the study.
How does the drug CM-101 differ from other treatments for primary sclerosing cholangitis?
CM-101 is unique because it is being tested as a potential treatment for primary sclerosing cholangitis, a condition for which no effective medical therapy currently exists. Unlike existing treatments that focus on symptom management or complications, CM-101 may offer a novel approach to addressing the underlying disease.12345
Research Team
Matthew Frankel, MD
Principal Investigator
ChemomAb Ltd.
Eligibility Criteria
Adults with Primary Sclerosing Cholangitis (PSC) can join this trial. They must not have liver cirrhosis, plans for a liver transplant, or certain blood test abnormalities. Women of childbearing age need a negative pregnancy test and must use contraception. People with stable inflammatory bowel disease are eligible, but those with recent colitis flares or major surgeries aren't.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-Blind Treatment
Participants receive either CM-101 or placebo every 3 weeks for 5 doses
Open-Label Treatment
Participants may opt to continue receiving CM-101 every 3 weeks for 11 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CM-101
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
ChemomAb Ltd.
Lead Sponsor