The SPRING Study
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis
IRAS ID
276391
Contact name
Douglas Thorburn
Contact email
Sponsor organisation
ChemomAb Ltd.
Eudract number
2019-002945-39
Clinicaltrials.gov Identifier
44492, NIHR
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
CM-101 is being developed by ChemomAb Ltd. for Primary Sclerosing Cholangitis (PSC). PSC is a rare, long-term, decrease in bile flow, liver disease characterised by progressive inflammation, thickening and scarring of connective tissue and destruction of the bile ducts inside and outside the liver with no identifiable cause. The decrease of bile to the intestines can lead to cirrhosis, liver failure, and other complications, including bile duct and liver cancer. Transplantation is the definitive treatment for PSC, though only those with advanced disease require a transplant. Experts believe PSC is a complex, multifactorial disorder that may encompass several liver, gallbladder, bile-ducts or bile diseases.
There is no known cure for PSC. Trials suggest that the natural bile acid, ursodeoxycholic acid, may inhibit progression of PSC by increasing bile flow and reducing liver inflammation.
ChemomAb evaluated levels of CCL24 (produced by cells of the immune system) in the blood sera of PSC patients. Increased levels of CCL24 were found in the liver of patients with PSC compared to healthy livers. Non-clinical data demonstrated that CM-101 binds and targets CCL24.
Patients will be randomly assigned to receive either CM-101 or placebo. Placebo is a dummy drug containing no medication. Two-thirds of patients will receive CM-101 and one-third receive placebo. Neither patient nor doctor will know which treatment the patient is getting. The study is designed to determine if CM-101 reduces the rate of progression of PCS compared to placebo.
Subjects will receive CM-101 or placebo 5 times intravenously once every 3 weeks over 12 weeks. There will be 8 study visits over 19 weeks followed by 2 follow-up calls. Subjects will be enrolled for approximately 12 months. At study visits, ultrasounds and other testing will be done.
Approximately 45 subjects will be enrolled at around 15 sites in the UK and Israel.REC name
London - South East Research Ethics Committee
REC reference
20/LO/0107
Date of REC Opinion
15 Apr 2020
REC opinion
Further Information Favourable Opinion