CM-101 in PSC Patients -The SPRING Study
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ClinicalTrials.gov Identifier: NCT04595825 |
Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Sclerosing Cholangitis | Biological: CM-101 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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- The SPRING Study |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: CM-101 |
Biological: CM-101
CM-101, Monoclonal Ab blocking CCL24 |
Placebo Comparator: Placebo |
Other: Placebo
Placebo |
- Alkaline Phosphatase Levels (ALP) [ Time Frame: 15 weeks ]Mean and percent change in ALP from baseline to Week 15
- Enhanced Liver Fibrosis (ELF) [ Time Frame: 15 weeks ]Mean change from baseline to Week 15 in Enhanced Liver Fibrosis (ELF) score
- Change in liver enzymes [ Time Frame: 15 weeks ]Percent change from baseline over time in liver enzymes (ALT, AST and GGT)
- Liver fibrosis markers [ Time Frame: 15 weeks ]Change from baseline to Week 15 in liver fibrosis markers such as PRO-C3 and PRO-C5
- PK profile [ Time Frame: 15 weeks ]Measurement of the serum CM-101 levels following repeated CM-101 administrations
- Anti-drug antibodies [ Time Frame: up to 27 weeks ]Evaluation of the development of anti-drug antibodies (ADA) following repeated CM-101 administrations

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of large duct PSC of > 24 weeks' duration
- No significant clinical concern for cholangiocarcinoma based on clinical, laboratory or imaging findings
- Subjects with concomitant IBD must have recent colonoscopy with biopsy confirming no dysplasia or cancer.
- Subjects with IBD must be in remission and have stable disease
- ConMed stable ≥12 weeks prior to randomization (including stable dose)
- Female subjects of childbearing potential, effective method of contraception from the Screening visit to 18 weeks post last dose
- Able to understand and sign ICF
Exclusion Criteria:
- Clinically significant causes or manifestations of sclerosing cholangitis other than PSC
- Patient that are planned for or post liver transplantation
- Patients with evidence of liver cirrhosis
- History of cholangiocarcinoma or a high clinical suspicion for cholangiocarcinoma
- Pregnant or breast feeding women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595825

Responsible Party: | ChemomAb Ltd. |
ClinicalTrials.gov Identifier: | NCT04595825 |
Other Study ID Numbers: |
CM-101-PSC-101 |
First Posted: | October 22, 2020 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anti-fibrotic |
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |