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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 : October 23, 2020
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 : September 2021
Estimated Study Completion Date : December 2021

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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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Israel
Soroka MC - site P23 Not yet recruiting
Be'er Sheva, Israel
Contact: Anat Nevo-Shor, MD    +972-52-4382066    KantorIr@clalit.org.il   
Rambam MC - site P22 Not yet recruiting
Haifa, Israel
Contact: Ella Veitsman, MD    +972-50-2063155    v_ben-hakoon@rambam.health.gov.il   
Hadassah Ein Kereme - site P21 Recruiting
Jerusalem, Israel, 91120
Contact: Rifaat Safadi, Prof. MD    +972-(0)2-6778539    reemk@hadassah.org.il   
Galilee Medical Center - site P24 Not yet recruiting
Nahariya, Israel
Contact: Assi Nimar, Prof. MD.    +972-4-9107748    NellyB@gmc.gov.il   
EMMS Nazareth Hospital - site P26 Not yet recruiting
Nazareth, Israel
Contact: Rifat Safadi, Prof. MD.    +972-2-6778539    ramighantous@yahoo.com   
Rabin MC - site P25 Recruiting
Petah Tikva, Israel
Contact: Amir Shlomai, MD    +972-50-7930305    rivkaha1@clalit.org.il   
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital - site P09 Not yet recruiting
Cambridge, United Kingdom
Contact: George Mells, MD    44-0-1223-245-151    abigail.ford@addenbrookes.nhs.uk   
NHS Greater Glasgow and Clyde - site P03 Recruiting
Glasgow, United Kingdom
Contact: Stephen Barclay, MD    +44-141-211-4000    susanne.cathcart@ggc.scot.nhs.uk   
King's College Hospital NHS Foundation Trust - site P04 Recruiting
London, United Kingdom
Contact: Deepak Joshi, MD    +44-0-203299-2504    adam.hossen-mamode@nhs.net   
The Royal Free Hospital - site P01 Not yet recruiting
London, United Kingdom
Contact: Douglas Thorburn, Prof. MD    + 44-20-3758-2000    wassy.fofana@nhs.net   
Norfolk and Norwich University Hospital - site P06 Recruiting
Norwich, United Kingdom
Contact: Simon Rushbrook, MD    +44-0-1603-286286    vanessa.martin@nnuh.nhs.uk   
Nottingham Digestive Diseases Centre Biomedical Research Unit - site P02 Not yet recruiting
Nottingham, United Kingdom
Contact: Stephen Ryder, MD    +44-115-924-9924    Nicola.Benetti@nuh.nhs.uk   
Plymouth Hospitals NHS Trust - Derriford Hospital - site P07 Not yet recruiting
Plymouth, United Kingdom
Contact: Matthew Cramp, MD    +44-1752792725    susan.inniss@nhs.net   
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: October 23, 2020
Last Verified: October 2020

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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
Streptococcal polysaccharide type III group B
Antineoplastic Agents