The SPRING Study
Research type
Research Study
Full title
A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis
IRAS ID
256707
Contact name
Douglas Thorburn
Contact email
Sponsor organisation
ChemomAb Ltd.
Eudract number
2018-004258-77
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
The SPRING study is a phase II open label study to evaluate the safety, tolerability and efficacy of a new study drug called CM-101. The study will recruit adult patients with Primary Sclerosing Cholangitis (PSC) at NHS hospitals in the UK. The study patients will participate for up to 31 weeks and they will receive multiple doses of the study drug (CM-101) as an intravenous infusion. It is anticipated that the study results will provide the researchers with important information regarding how safe the drug is, how well tolerated the drug is and whether the drug shows signs of efficiacy in the intended PSC patient population.
REC name
HSC REC A
REC reference
18/NI/0236
Date of REC Opinion
5 Feb 2019
REC opinion
Further Information Favourable Opinion