CM-101 in PSC Patients -The SPRING Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

Key facts

Study ID

NCT04595825

Run by

ChemomAb Ltd.

People needed

77

Starts

2020-10-01

Expected to finish

2025-01-10

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with diagnosis of large duct PSC of more than 24 weeks' duration
• Subjects that have no significant clinical concern for cholangiocarcinoma based on clinical, laboratory or imaging findings
• Subjects with serum Alkaline phosphatase (ALP) greater than 1.5 × Upper limit of normal (ULN) in Screening blood tests.
• Subjects receiving Ursodeoxycholic acid (UDCA) must receive a stable dose for ≥12 weeks prior to Screening
• Subjects with concomitant inflammatory bowel disease (IBD) is allowed but not required, and must meet the following stability criteria.
• Subjects with ulcerative colitis: Must be either in remission or have mild disease. Must have recent colonoscopy with biopsy confirming no dysplasia or colorectal cancer or history of colectomy.
• Subjects with Crohn's Disease must be in remission as defined by a Crohn's Disease Activity Index (CDAI) < 150.
• Subjects receiving concomitant medication for IBD, dose must be stable ≥12 weeks prior to screening and dose should remain stable during DB portion of the study
• Subjects receiving concomitant medication for their PSC must be on stable therapy ≥12 weeks prior to randomization and plan to remain on that stable dose during the DB portion of the study
• Female subjects of childbearing potential, must have a negative serum pregnancy test prior to starting study treatment and must have agree to highly effective method of contraception from the Screening Visit throughout the study period including 18 weeks post last dose
• Male subjects, if not vasectomized, must agree to use barrier contraception from screening through to study completion and for 90 days from the last dose of study drug

You may not qualify if…

• Subjects with presence of documented secondary sclerosing cholangitis on prior clinical investigations
• Subjects with presence of competing etiology of liver disease.
• Subjects with possible overlap syndrome with autoimmune hepatitis are excluded if the Investigator considers autoimmune hepatitis as the predominant liver injury
• Subjects with small duct PSC in the absence of large duct disease
• Subjects with percutaneous biliary drain or bile duct stent or subjects who had required biliary drainage within 12 weeks of Screening
• Subjects that have undergone prior biliary surgery other than those who at the time of screening are more than 6 weeks after cholecystectomy without surgical complications
• Subjects with evidence of liver cirrhosis, as determined by local transient elastography values of ≥ 14.4 kPa obtained during the Screening period. In case of a fibrosis staging discrepancy between a recent (≤ 12 months) liver biopsy staging and the transient elastography results, eligibility will be based on the liver biopsy staging.
• History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C), and/or hepatic decompensation including ascites, encephalopathy, or variceal bleeding
• Subjects who have undergone or are planned for liver transplantation or with current model of end stage liver disease
• Subjects with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) values > 5 × ULN as determined at Screening
• Subjects who show 'clinically significant' lab changes at Screening
• Subjects with serum total bilirubin values > 3 × ULN at Screening
• Subjects with known Gilbert's syndrome or a history of elevations in unconjugated (indirect) bilirubin >ULN
• Subjects with international normalized ratio (INR) >1.5 which does not correct on vitamin K replacement, in the absence of anticoagulants
• Subjects with serum creatinine > 1.4 mg/dL (123 μmol/L) and/or a platelet count < 100 × 109 /L
• Subjects with history of cholangiocarcinoma or a high clinical suspicion for cholangiocarcinoma
• Subjects with elevated cancer antigen 19-9 (Ca 19-9) value (> 129 U/mL) within 12 months prior to Screening unless Ca 19-9 levels have been stable and clinical evaluation and repeated Magnetic resonance imaging (MRI) within the same time period has not provided evidence of cholangiocarcinoma
• Subjects with a prior biliary stricture necessitating intervention should be stable for ≥ 24 weeks prior to randomization without intervention, or episode of cholangitis, and should show a low level of clinical suspicion of cholangiocarcinoma
• Subjects with current known portal hypertension with complications, including known gastric or large esophageal varices, poorly controlled or diuretic resistant ascites, history of variceal bleeds, or related therapeutic or prophylactic interventions
• Subjects with active malignancy (diagnosed and/or treated within 3 years of randomization), other than:
• adequately treated non-metastatic basal cell skin cancer
• squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to randomization
• history of cervical carcinoma in situ that has been adequately treated and that has not recurred.
• Subjects with a 'clinically significant' (as judged by the Investigator) unexplained weight loss during the 24 weeks prior to randomization
• Subjects showing deleterious effects of alcohol abuse or that consume excessive amounts of alcohol

Where it is running

• Scripps Clinic Torrey Pines - site P83 — La Jolla, California, United States
• UC Davis Health System - Midtown Ambulatory Care Center - site P79 — Sacramento, California, United States
• Northwestern University - site P77 — Chicago, Illinois, United States
• Massachusetts General Hospital - site P95 — Boston, Massachusetts, United States
• Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - Liver Center - site P81 — Boston, Massachusetts, United States
• Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park - site P82 — Germantown, Tennessee, United States
• Methodist Dallas Medical Center - site P72 — Dallas, Texas, United States
• Virginia Commonwealth - site P94 — Richmond, Virginia, United States
• Klinikum der Johann Wolfgang Goethe-Universitaet - site P42 — Frankfurt am Main, Germany
• Universitätsklinikum Hamburg-Eppendorf (UKE) - site P47 — Hamburg, Germany
• Medizinische Hochschule Hannover (MHH) - site P41 — Hanover, Germany
• Soroka MC - site P23 — Beersheba, Israel
• Shamir Medical Center (Assaf Harofeh) - site P28 — Be’er Ya‘aqov, Israel
• Carmel - site P27 — Haifa, Israel
• Rambam MC - site P22 — Haifa, Israel
• Hadassah Ein Kereme - site P21 — Jerusalem, Israel
• Shaarei Tszedek Medical Center - site P29 — Jerusalem, Israel
• Galilee Medical Center - site P24 — Nahariya, Israel
• EMMS Holy Family Nazareth Hospital - site P26 — Nazareth, Israel
• Assuta Medical Center - site P31 — Tel Aviv, Israel
• Tel-Aviv Sourasky Medical Center - site P30 — Tel Aviv, Israel
• Hospital Clínic de Barcelona - site P67 — Barcelona, Spain
• Hospital Universitario Ramón y Cajal - site P61 — Madrid, Spain
• Hospital Universitari i Politècnic La Fe - site P64 — Valencia, Spain
• Hospital Universitario Miguel Servet - site P65 — Zaragoza, Spain

Full record on ClinicalTrials.gov

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