Clinical Trial

Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis (PSC) is a chronic progressive cholestatic disease of the liver characterized by inflammation and strictures of the biliary tree inside and/or outside the liver. The pathological hallmarks of PSC include injury to the integrity of the biliary ducts, retention of bile acids and intrahepatic inflammation and progressive liver fibrosis.

Chemomab is Testing the Novel Biologic Drug, CM-101, Which it has Developed for Treating PSC:

  • CM-101 targets the soluble protein CCL24, which was found to play a pivotal role in promoting fibrotic and inflammatory activities in the liver through its receptor, CCR3
  • Chemomab has demonstrated that CCL24 is strongly expressed in PSC patients’ liver samples (biopsies), while its levels in the blood correlate with the state of liver fibrosis

Chemomab conducted pre-clinical tests of CM-101 in multiple PSC animal models, and found that CM-101 was effective and significantly attenuated disease severity.

Chemomab also tested CM-101 in healthy volunteers and patients with non-alcoholic fatty liver disease (NAFLD) and found CM-101 to be safe and well tolerated in all tested doses. In the current study, for the first time, Chemomab will evaluate CM-101 for treating PSC patients. The SPRING study will test CM-101 activity, safety and tolerability in adult PSC patients.

This is a phase 2a study, administering 5 intravenous infusions once every 3 weeks over 12 weeks of either the tested drug (CM-101) or placebo.

Key Eligibility Criteria

  • Males and females, 18 to 75 years of age

  • Patient has been diagnosed via MRCP/ERCP with large-duct PSC (intrahepatic and/or extrahepatic) and has had the condition for at least 24 weeks

  • ALP level must be > 1.5 ULN

  • Patients with a diagnosis of concomitant IBD are eligible to participate, however, their IBD must be in remission

  • UDCA treatment is allowed at doses below 23 mg/kg/day and stable for at least 12 weeks

  • Patients with biliary drain or bile duct stents are not eligible

  • Patients’ concomitant medications must be stable for at least 12 weeks

SPRING Study Procedures

Participants will sign an informed consent form and will be screened to make sure they are eligible to join the study.

If eligible, participants will be randomly assigned to receive IV infusions of the study drug or a placebo. Participants will visit the study site once every 3 weeks for 12 weeks of treatment. An additional interim safety visit will take place 7 days after the first treatment. After the last treatment participants will enter 15 weeks of study follow up. This study does not involve liver biopsies.

In total, each study participant will visit the testing site 8 times over 6 months.

This Study is Open for Recruitment

NIH number: NCT04595825

Screening

4 weeks

Treatment Period

12 weeks: Drug administration once every 3 weeks, for a total of 5 treatments

Safety Follow-up

15 weeks after last treatment

Locations

UK

The Royal Free Hospital
Pond Street, Hampstead, London, NW3 2QG

NHS Greater Glasgow and Clyde
10-16 Alexandra Parade, Glasgow ,G31 2ER

Oxford University Hospitals NHS Foundation Trust
Headley Way, Oxford, OX3 9DU

The Royal Free Hospital
Pond Street, Hampstead, London, NW3 2QG

The University of Nottingham
Derby Road, Nottingham, NG7 2UH

King’s College Hospital NHS Foundation Trust
Denmark Hill, London, SE5 9RS

Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH

Cambridge University Hospitals NHS Foundation Trust
Hills Road, Cambridge, CB2 0QQ

Israel

Hadassah Medical Center
Kiryat Hadassah, Ein Kerem, Jerusalem

Soroka University Medical Center
Ben Gurion Avenue, Beer-Sheva

Galilee Medical Center
Nahariya 22100

Carmel Medical Center
2 Horev St. Haifa

Hadassah Medical Center
Kiryat Hadassah, Ein Kerem, Jerusalem

Rambam Medical Center
8th HaAliya HaShniya St., Haifa

EMMS Nazareth Hospital
Nazareth

Shamir Medical Center (Assaf Harofeh)
Beer Yaakov , Zerifin

Download Patient Leaflet