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CM-101 in PSC Patients -The SPRING Study

Sponsor
ChemomAb Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04595825
Collaborator
(none)
45
Enrollment
21
Locations
2
Arms
23
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: CM-101
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM-101

Biological: CM-101
CM-101, Monoclonal Ab blocking CCL24
Placebo Comparator: Placebo

Other: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Alkaline Phosphatase Levels (ALP) [15 weeks]

    Mean and percent change in ALP from baseline to Week 15

  2. Enhanced Liver Fibrosis (ELF) [15 weeks]

    Mean change from baseline to Week 15 in Enhanced Liver Fibrosis (ELF) score

Secondary Outcome Measures

  1. Change in liver enzymes [15 weeks]

    Percent change from baseline over time in liver enzymes (ALT, AST and GGT)

  2. Liver fibrosis markers [15 weeks]

    Change from baseline to Week 15 in liver fibrosis markers such as PRO-C3 and PRO-C5

  3. PK profile [15 weeks]

    Measurement of the serum CM-101 levels following repeated CM-101 administrations

  4. Anti-drug antibodies [up to 27 weeks]

    Evaluation of the development of anti-drug antibodies (ADA) following repeated CM-101 administrations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitaetsklinikum Bonn Bonn Germany
2 Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt am Main Germany
3 Medizinische Hochschule Hannover (MHH) Hannover Germany
4 University Hospital Jena Jena Germany
5 Medizinische Fakultät Mannheim der Universität Heidelberg Mannheim Germany
6 LMU - Klinikum der Universitaet Muenchen Munich Germany
7 Soroka MC - site P23 Be'er Sheva Israel
8 Rambam MC - site P22 Haifa Israel
9 Hadassah Ein Kereme - site P21 Jerusalem Israel 91120
10 Galilee Medical Center - site P24 Nahariya Israel
11 EMMS Nazareth Hospital - site P26 Nazareth Israel
12 Rabin MC - site P25 Petah Tikva Israel
13 University Hospitals Birmingham NHS Foundation Trust - site P05 Birmingham United Kingdom
14 Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital - site P09 Cambridge United Kingdom
15 NHS Greater Glasgow and Clyde - site P03 Glasgow United Kingdom
16 King's College Hospital NHS Foundation Trust - site P04 London United Kingdom
17 The Royal Free Hospital - site P01 London United Kingdom
18 Norfolk and Norwich University Hospital - site P06 Norwich United Kingdom
19 Nottingham Digestive Diseases Centre Biomedical Research Unit - site P02 Nottingham United Kingdom
20 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
21 Plymouth Hospitals NHS Trust - Derriford Hospital - site P07 Plymouth United Kingdom

Sponsors and Collaborators

  • ChemomAb Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ChemomAb Ltd.
ClinicalTrials.gov Identifier:
NCT04595825
Other Study ID Numbers:
  • CM-101-PSC-101
First Posted:
Oct 22, 2020
Last Update Posted:
Sep 2, 2021
Last Verified:
Sep 1, 2021
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:
Cholangitis
Cholangitis, Sclerosing

Study Results

No Results Posted as of Sep 2, 2021