Brief Summary

This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment groups: 5 mg/kg CM-101 or placebo.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

February 24, 2021

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed

10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed

8 months until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed

Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

December 6, 2021

Last Update Submit

April 11, 2023

Conditions

Nonalcoholic Steatohepatitis

Keywords

Anti-fibrotic

Outcome Measures

Primary Outcomes (1)

Safety-related endpoints - Treatment emergent adverse events (TEAEs)
The safety and tolerability will be assessed by monitoring treatment emergent adverse events (TEAEs)
14-week treatment period

Secondary Outcomes (20)

Serum biomarkers for pharmacodynamic parameters - Enhanced liver function (ELF™) Blood Test
Change from baseline to week 16
Serum biomarkers for pharmacodynamic parameters - Pro-C3
Change from baseline to week 16
Serum biomarkers for pharmacodynamic parameters - PRO-C4
Change from baseline to week 16
Serum biomarkers for pharmacodynamic parameters - C3M
Change from baseline to week 16
Serum biomarkers for pharmacodynamic parameters - Cytokeratin-18 (cCK-18) (full length and fragments; M65, M30)
Change from baseline to week 16
+15 more secondary outcomes

Study Arms (2)

5 mg/kg CM-101

EXPERIMENTAL

Subcutaneous injection CM-101 every 2 weeks

Biological: 5 mg/kg CM-101

Placebo

PLACEBO COMPARATOR

Subcutaneous Injection Placebo every 2 weeks

Other: Placebo

Interventions

5 mg/kg CM-101BIOLOGICAL

CM-101, Monoclonal Ab blocking CCL24

5 mg/kg CM-101

PlaceboOTHER

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological confirmation of steatohepatitis and fibrosis without cirrhosis on a diagnostic liver biopsy obtained within the 18 months prior to the start of treatment, and/or during the screening period with:
a. NAS ≥ 4 with a score of at least 1 for each component (steatosis, ballooning degeneration and lobular inflammation) and b. Hepatic fibrosis stage F1c, 2 or 3 as defined by the NASH CRN scoring scale. F1c subjectspatients must have either: PRO-C3 \>14 ng/ml or Liver stiffness value of \>8.0 kPa measured by transient elastography
Patients with presence of greater than or equals to (≥) 10 percent (%) steatosis on MRI-derived proton-density fat-fraction (PDFF) performed as part of the screening procedure or within 12 weeks prior to randomization
Confirmation of disease status from time of biopsy by Transient Elastography performed during the screening period with liver stiffness value of 7-12 kPa.
Patients with presence of ≥1 of the following risk factors:
Obesity (BMI ≥30 kg/m2),
Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria,
HTN per 2017 AHA Guidelines for Hypertension,
ALT \>1.5× upper limit of normal (ULN)
Patients with a stable body mass index (BMI) between 25- 45 kg/m², both inclusive. Body weight is required to be stable (i.e., not varying by \> 5% for at least 12 weeks) prior to study entry;
Patients on chronic medication must be on a stable regimen for ≥ 12 weeks prior to Randomization and should attempt to maintain a stable dosing regimen during the study period;
Patients must have the following laboratory parameters at screening:
Total bilirubin \< 1.5 mg/dL (26 micromol/L)
AST \< 5 x ULN
INR \< 1.3
+5 more criteria

You may not qualify if:

Patients with medical/surgical history of bariatric surgery procedures or bariatric device insertion or patients that are planned for such interventions;
Patients taking weight loss medications;
Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis;
History or presence of cirrhosis (compensated or decompensated) determined by histology or relevant medical complications and laboratory parameters;
Model for End-stage Liver Disease (MELD) score \>12;
History of liver transplant, or current evaluation for or placement on a liver transplant waiting list;
Abnormal laboratory screening values:
Hemoglobin \< 12.0 g/dL in males and \< 11.0 g/dL in females
Platelet count \< 140,000/mm3
Total white blood cells (WBC) \< 3,000 cells/mm3
Absolute neutrophil count (ANC) \< 1,500 cells/mm3
Serum albumin \< 3.5 g/dL
Screening ECG demonstrating prolongation of QT interval corrected by Fredericia Correction Formula (QTcF) of \> 500 msec, or a history of clinically significant arrythmias
History of other chronic liver diseases including:
Alcoholic liver disease
+29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ChemomAb Ltd.lead

Study Sites (9)

Soroka Medical Center - site 203

Beersheba, Israel

Location

Carmel Medical Center - site 207

Haifa, Israel

Location

Rambam Medical Center - site 202

Haifa, Israel

Location

Hadassah Ein Kereme - site 201

Jerusalem, 91120, Israel

Location

Shaare Zedek Medical Center - site 208

Jerusalem, Israel

Location

Galilee Medical Center - site 204

Nahariya, Israel

Location

Holy Family Nazareth Hospital - site 206

Nazareth, Israel

Location

Rabin Medical Center - site 205

Petah Tikva, Israel

Location

The Haim Sheba Medical Center - site 209

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

streptococcal polysaccharide type III group B

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

Matthew Frankel, MD
ChemomAb Ltd.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

April 21, 2023

Study Start

February 24, 2021

Primary Completion

August 15, 2022

Study Completion

August 25, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing: Will not share

Locations

IL(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (2)

5 mg/kg CM-101

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations