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CM-101 for Primary Sclerosing Cholangitis
Study Summary
This trial will test a new drug to treat Primary Sclerosing Cholangitis, in 93 people at 75 sites, to see if it's safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not experienced harmful effects from alcohol or unexplained weight loss in the last 6 months.I have not had major surgery or an organ transplant in the last 60 days.I am a man who will use barrier contraception during and up to 90 days after the study if I am not vasectomized.I am not pregnant and will use birth control during and for 18 weeks after the study.I have been diagnosed with liver cirrhosis.I am planning to have or have had a liver transplant.You have had an allergic reaction to antibodies made from Chinese hamster ovary cells, a drug called CM-101, or any other ingredients in the medication.I am not taking any medications that are not allowed in the study.I have had or might have had a bile duct infection in the last 3 months.I have a history of severe liver problems, including cirrhosis or liver failure.I have or am suspected to have cholangiocarcinoma.I do not have autoimmune hepatitis as my main liver issue.Subjects with serum Alkaline phosphatase (ALP) levels exceeding 1.5 times the upper limit of normal in Screening blood tests.I have or had a biliary drain or stent within the last 3 months.You have significant health changes at the time of screening.I have Gilbert's syndrome or had high levels of indirect bilirubin.I have IBD and am in remission or have stable disease, with recent tests showing no cancer.I have severe liver issues with complications like varices or ascites.My medication doses have been stable for at least 12 weeks.You have lost a lot of weight in the last 24 weeks without any clear explanation, as determined by the investigator.I haven't been in a drug or device trial recently or enough time has passed since my last trial dose.I had gallbladder surgery over 6 weeks ago with no complications.My CA 19-9 levels were high but stable, with no signs of cholangiocarcinoma on recent tests.I have had a severe colitis flare-up needing more treatment or hospitalization in the last 3 months.I do not have any health conditions that would prevent me from following the study's requirements.My INR is over 1.5 and doesn't normalize with vitamin K, and I'm not on blood thinners.I have small duct primary sclerosing cholangitis without large duct involvement.My doctors do not suspect I have bile duct cancer based on tests.I have not received a live vaccine in the last 30 days.I currently have an active infection.I have had a stable biliary condition for at least 24 weeks without needing intervention.I am not taking fenofibrate or similar medications, or my dose has been stable for 24 weeks.I have chronic hepatitis B or C, or tested positive for hepatitis B.I am not pregnant or breastfeeding.I have another liver condition besides my current diagnosis.I haven't taken any biologic treatments like anti-TNF or anti-integrin antibodies in the last 24 weeks.I have been taking a consistent dose of UDCA for at least 12 weeks.I have been diagnosed with large duct PSC for more than 24 weeks.I have no active cancer except for certain skin cancers or treated cervical cancer without recurrence in the last year.
- Group 1: Anti-human CCL24 monoclonal antibody (CM-101)
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial offer participation for minors?
"The eligibility requirements for this clinical trial offer the opportunity to participate in it to those between 18 and 75 years of age. Additionally, there are separate trials dedicated specifically to younger patients below 18 as well as seniors above 65."
Is it possible to partake in this experiment?
"Eligibility criteria for this clinical trial necessitates that potential participants have a diagnosis of primary sclerosing cholangitis and are aged between 18-75. Presently, the research team is looking to enroll around 93 individuals."
Have you begun to accept candidates for this research project?
"As indicated by clinicaltrials.gov, this medical trial is currently recruiting patients to participate. It was first posted on October 1st 2020 and its most recent update occured on March 18th 2023."
What level of risk does the Anti-human CCL24 monoclonal antibody (CM-101) pose to those receiving treatment?
"Our team at Power has judged the safety of Anti-human CCL24 monoclonal antibody (CM-101) to be a 2 on our 1–3 scale. This is because, while there is some existing data demonstrating its safety, no evidence exists yet that supports its efficacy."
What is the sample size of this research project?
"This clinical trial necessitates 93 willing participants who meet the necessary requirements. Eligible patients may participate at sites such as Northwestern University - site P77 in Chicago, IL and Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) Liver Center - site P81 in Boston, MA."
How many venues are conducting this clinical research?
"This trial is being executed from Northwestern University's P77 site in Chicago, IL; Harvard Medical School and Beth Israel Deaconess Medical Center (BIDMC) Liver Centre -P81 in Boston, MA; New york-Presbyterian Hospital/Weill Cornell Medical Center's P80 location in NYC as well as 50 additional sites."
What ultimate goal does this clinical trial intend to accomplish?
"According to the study's sponsor, ChemomAb Ltd., their primary assessment of efficacy will be Alkaline Phosphatase Levels (ALP) over an interval of 48 weeks. Additionally, a number other markers such as Enhanced Liver Fibrosis (ELF), ALP Response Rates, and Percent Changes in liver enzymes levels will also be monitored."
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