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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
Sponsor:
Information provided by (Responsible Party):
ChemomAb Ltd.

Study Description
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Brief Summary:
This study is designed to assess the safety, tolerability and activity of CM-101 in patients with Primary Sclerosing Cholangitis (PSC).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Biological: CM-101 Other: Placebo Phase 2

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CM-101 Biological: CM-101
CM-101, Monoclonal Ab blocking CCL24
Placebo Comparator: Placebo Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Alkaline Phosphatase Levels (ALP) [ Time Frame: 15 weeks ]
    Mean and percent change in ALP from baseline to Week 15

  2. Enhanced Liver Fibrosis (ELF) [ Time Frame: 15 weeks ]
    Mean change from baseline to Week 15 in Enhanced Liver Fibrosis (ELF) score


Secondary Outcome Measures :
  1. Change in liver enzymes [ Time Frame: 15 weeks ]
    Percent change from baseline over time in liver enzymes (ALT, AST and GGT)

  2. Liver fibrosis markers [ Time Frame: 15 weeks ]
    Change from baseline to Week 15 in liver fibrosis markers such as PRO-C3 and PRO-C5

  3. PK profile [ Time Frame: 15 weeks ]
    Measurement of the serum CM-101 levels following repeated CM-101 administrations

  4. Anti-drug antibodies [ Time Frame: up to 27 weeks ]
    Evaluation of the development of anti-drug antibodies (ADA) following repeated CM-101 administrations


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
ChemomAb Ltd.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ChemomAb Ltd.:
Anti-fibrotic
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases