Evaluating The Safety And Efficacy Of CM-101 in Patients with PSC
The SPRING Study
Thinking of taking part?
- Check how suitable you are by looking at the information below.
- Check our map to see if you can get to a study site.
- Contact the research team for more details if you think you are suitable. Check back regularly as we are adding more contact info every day.
- Got a question? Our Clinical Trials Pack has lots of information about how to join clinical trials, switching hospitals for trials and what's involved.
- Contact us if you need any help.
CCL24 is a small protein involved in cell “communication” that helps regulate inflammation and is involved in the development of fibrosis (scarring). CCL24 is found in higher concentrations in PSC patients than the general population.
CM-101 is a monoclonal antibody, created by ChemomAb, that can block the actions of CCL24 and thus its role in the development of inflammation and fibrosis. CM-101 was tested in several animal models, including the MDR2 knockout mice (mice that have severe fibrosis in the bile ducts and liver, eventually developing cirrhosis). These tests showed that CM-101 significantly reduced liver fibrosis, and markers that indicate the presence of inflammation in the bile ducts.
|Trial Name||The SPRING Study|
|Phase||Phase 2a trial|
|Intervention||CM-101 intravenous infusions over an hour - once every three weeks for 5 administrations|
|Participating Centres||See PSC Support map, the current sites list on Clinicaltrials.gov and UK-PSC for up-to-date status for each centre.|
|Liver disease diagnosis||You must have a diagnosis of large duct PSC (combination of large and small duct PSC is allowed).
Note autoimmune hepatitis is allowed as long as it isn’t considered to be more active than PSC.
|Age||You must be an adult (18 years and above)|
|Females: can I be pregnant?||No|
|Is IBD allowed?||Yes - if it is mild and in remission - no colitis flare within the previous 90 days|
|Is there an ALP (alkaline phosphatase) requirement?||ALP should be at least 1.5 times the upper limit of the normal range (ULN), in 2 separate tests (once during screening and one during randomisation)|
|Can I take UDCA (Urso)?||Yes - UDCA is allowed if you are on a stable dose (dose must not exceed 23mg/kg/day) or off UDCA for at least 12 weeks|
|Can I take part if I have a stent?||No|
|Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed?||No cholangitis attack within 90 days of randomisation|
|Can I take part if I have had a liver transplant?||No|
|Is cirrhosis allowed?||No|
|Previous studies and information||
|Are travel expenses covered?||Yes, and snacks.
If an overnight stay is needed, it will be reimbursed.
|Procedures and tests include:||Blood sample, Fibroscan, ultrasound scans, urine sample (+pregnancy testing), patient questionnaires.|
|How many study visits will there be? How long will each study visit be?||The study includes a treatment, once every 3 weeks for 12 weeks. There will then be 15 weeks of safety follow-up including 2 visits and 1 phone calls.
(2 long visits of about 6-7 hours and 5 shorter visits of about 2-3 hours).
|Duration of study||Treatment period of 12 weeks and follow up period of 15 weeks.|
|Basic design of study||Randomised, Double Blind, Placebo Controlled Study
Volunteers will be randomised to receive the study drug (CM-101) or placebo in a 2:1 ratio. (This means two out over every three participants will receive the study drug, and one out of three will receive the placebo).
|Link to Sponsor||ChemomAb|