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CM-101 in PSC Patients -The SPRING Study

NCT04595825 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

BIOLOGICAL

Anti-human CCL24 monoclonal antibody (CM-101)

Anti-human CCL24 monoclonal antibody (CM-101) 100 mg Intravenous Infusion over 60 minutes (±5 minutes)

OTHER

Placebo

Placebo - intravenous infusion

Sponsors & Collaborators

  • ChemomAb Ltd.

    lead INDUSTRY

Principal Investigators

  • Matthew Frankel, MD · ChemomAb Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595825 on ClinicalTrials.gov