CM-101 for Primary Sclerosing Cholangitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, CM-101, for individuals with Primary Sclerosing Cholangitis (PSC), a liver disease that causes bile duct inflammation and scarring. Researchers aim to determine the safety and effectiveness of CM-101 by comparing it to a placebo, a harmless substance with no active drug. Participants should have a PSC diagnosis for over 24 weeks and meet specific liver test criteria. This trial may suit those already on stable medication for PSC or inflammatory bowel disease (IBD). As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CM-101 is generally safe. In both human and animal studies, participants tolerated this treatment well, and no major safety issues emerged. CM-101 is a monoclonal antibody that targets specific proteins responsible for inflammation and scarring, helping to reduce these harmful effects. Overall, CM-101 appears to be a safe option for those considering participation in a clinical trial for Primary Sclerosing Cholangitis.12345
Why do researchers think this study treatment might be promising for PSC?
Most treatments for Primary Sclerosing Cholangitis focus on managing symptoms and complications, as there is currently no cure. However, CM-101 is unique because it targets a specific protein, CCL24, with an anti-human CCL24 monoclonal antibody. This new mechanism of action is exciting because it directly addresses inflammation and fibrosis, which are central to the disease's progression. By potentially slowing or reversing these processes, CM-101 offers a novel approach that could change the treatment landscape for this challenging condition.
What evidence suggests that CM-101 might be an effective treatment for Primary Sclerosing Cholangitis?
Research has shown that CM-101, a monoclonal antibody, holds potential for treating primary sclerosing cholangitis (PSC). In this trial, participants will receive either CM-101 or a placebo. Studies have found that after 15 weeks of treatment, CM-101 can reduce scarring, inflammation, and blockages in bile flow in people with PSC. The treatment has proven safe and well-tolerated, with improvements in key health markers related to inflammation and scarring. These findings suggest that CM-101 could offer a new and effective treatment option for PSC, addressing several aspects of the disease.12678
Who Is on the Research Team?
Matthew Frankel, MD
Principal Investigator
ChemomAb Ltd.
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- CM-101
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
ChemomAb Ltd.
Lead Sponsor