CM-101 for Primary Sclerosing Cholangitis

Not currently recruiting at 54 trial locations

Overseen By Chemomab Patient Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ChemomAb Ltd.

Must be taking: Ursodeoxycholic acid

Must not be taking: Fenofibrate, Fibrates

Disqualifiers: Cirrhosis, Hepatitis B/C, Alcohol abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CM-101, for individuals with Primary Sclerosing Cholangitis (PSC), a liver disease that causes bile duct inflammation and scarring. Researchers aim to determine the safety and effectiveness of CM-101 by comparing it to a placebo, a harmless substance with no active drug. Participants should have a PSC diagnosis for over 24 weeks and meet specific liver test criteria. This trial may suit those already on stable medication for PSC or inflammatory bowel disease (IBD). As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that participants stay on a stable dose of their current medications for Primary Sclerosing Cholangitis (PSC) and inflammatory bowel disease (IBD) for at least 12 weeks before joining the study and continue on that stable dose during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CM-101 is generally safe. In both human and animal studies, participants tolerated this treatment well, and no major safety issues emerged. CM-101 is a monoclonal antibody that targets specific proteins responsible for inflammation and scarring, helping to reduce these harmful effects. Overall, CM-101 appears to be a safe option for those considering participation in a clinical trial for Primary Sclerosing Cholangitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PSC?

Most treatments for Primary Sclerosing Cholangitis focus on managing symptoms and complications, as there is currently no cure. However, CM-101 is unique because it targets a specific protein, CCL24, with an anti-human CCL24 monoclonal antibody. This new mechanism of action is exciting because it directly addresses inflammation and fibrosis, which are central to the disease's progression. By potentially slowing or reversing these processes, CM-101 offers a novel approach that could change the treatment landscape for this challenging condition.

What evidence suggests that CM-101 might be an effective treatment for Primary Sclerosing Cholangitis?

Research has shown that CM-101, a monoclonal antibody, holds potential for treating primary sclerosing cholangitis (PSC). In this trial, participants will receive either CM-101 or a placebo. Studies have found that after 15 weeks of treatment, CM-101 can reduce scarring, inflammation, and blockages in bile flow in people with PSC. The treatment has proven safe and well-tolerated, with improvements in key health markers related to inflammation and scarring. These findings suggest that CM-101 could offer a new and effective treatment option for PSC, addressing several aspects of the disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew Frankel, MD

Principal Investigator

ChemomAb Ltd.

Are You a Good Fit for This Trial?

Adults with Primary Sclerosing Cholangitis (PSC) can join this trial. They must not have liver cirrhosis, plans for a liver transplant, or certain blood test abnormalities. Women of childbearing age need a negative pregnancy test and must use contraception. People with stable inflammatory bowel disease are eligible, but those with recent colitis flares or major surgeries aren't.

Inclusion Criteria

I am a man who will use barrier contraception during and up to 90 days after the study if I am not vasectomized.

I am not pregnant and will use birth control during and for 18 weeks after the study.

Subjects with serum Alkaline phosphatase (ALP) levels exceeding 1.5 times the upper limit of normal in Screening blood tests.

Exclusion Criteria

I have not experienced harmful effects from alcohol or unexplained weight loss in the last 6 months.

I have not had major surgery or an organ transplant in the last 60 days.

Subjects with any identified congenital or acquired immune-deficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive either CM-101 or placebo every 3 weeks for 5 doses

15 weeks

5 visits (in-person)

Open-Label Treatment

Participants may opt to continue receiving CM-101 every 3 weeks for 11 doses

33 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person), 1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CM-101
• Placebo

Trial Overview

The SPRING Study is testing the safety and effectiveness of CM-101, an anti-human CCL24 monoclonal antibody, in treating PSC. Participants will be randomly assigned to receive either CM-101 at two different doses or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Anti-human CCL24 monoclonal antibody (CM-101) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Placebo - intravenous infusion

Who Is Running the Clinical Trial?

ChemomAb Ltd.

Lead Sponsor

Trials

6

Recruited

190+

Published Research Related to This Trial

In a study of 22 patients with primary sclerosing cholangitis (PSC), common symptoms included fatigue, dark urine, and weight loss, with significant biochemical abnormalities observed at admission, such as elevated alkaline phosphatase and bilirubin levels.

Treatment with ursodeoxycholic acid (UDCA) did not show a statistically significant improvement in patient outcomes compared to those not receiving UDCA, indicating that while some patients improved, the therapy may not enhance prognosis overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical and pathological analysis of 22 cases of primary sclerosing cholangitis]. Liu, HH., Fu, JL., Luo, SQ., et al.[2018]

Primary sclerosing cholangitis (PSC) is a progressive liver disease with no effective treatments currently available, and it often leads to serious complications like cirrhosis and bile duct cancer over a long period, typically a decade or more.

Management of PSC focuses on symptom relief and addressing complications, with options like balloon dilatation for strictures and liver transplantation for advanced cases, while experimental therapies such as immunosuppressive and choleretic agents are being tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fifth Carlos E. Rubio Memorial Lecture. Sclerosing cholangitis: pathogenesis, pathology, and practice. Larusso, NF.[2018]

Citations

1.

gut.bmj.com

gut.bmj.com/content/74/Suppl_1/A22.2

O33 CM101, a novel monoclonal antibody targeting ...

CM-101 exhibited anti-fibrotic, anti-inflammatory and anti-cholestatic activity in patients with PSC after 15 weeks of treatment.

2.

investors.chemomab.com

investors.chemomab.com/2024-07-25-Chemomab-Therapeutics-Announces-Positive-Phase-2-Trial-Results-CM-101-Achieves-Primary-and-Secondary-Endpoints-Demonstrating-Anti-Fibrotic,-Anti-Inflammatory-and-Anti-Cholestatic-Effects-in-Patients-with-Primary-Sclerosing-Cholangitis

Chemomab Investor Relations - News

Chemomab has reported positive results from four clinical trials of CM-101, including a Phase 2 trial in patients with primary sclerosing ...

3.

touchimmunology.com

touchimmunology.com/insight/findings-from-the-spring-study-cm-101-for-primary-sclerosing-cholangitis-paul-pockros-ddw-2025/

Findings from the Spring Study – CM-101 for Primary ...

CM-101, a novel monoclonal antibody targeting CCL24, was safe, well-tolerated and showed improvements of biomarkers associated with inflammation, fibrosis and ...

4.

investors.chemomab.com

investors.chemomab.com/2025-04-28-Chemomab-Reports-New-Positive-Clinical-Data-at-EASL-2025-Supporting-Nebokitugs-Impact-in-Primary-Sclerosing-Cholangitis-and-Related-Diseases

Chemomab Reports New Positive Clinical Data at EASL 2025 ...

This new clinical data further confirms the potential of nebokitug (CM-101) as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other ...

5.

pscsupport.org.uk

pscsupport.org.uk/find-psc-research-studies/cm-101-psc-clinical-trial-spring/

CM-101 PSC Clinical Trial SPRING

CM-101 is a monoclonal antibody, created by Chemomab, that can block the actions of CCL24 and thus its role in the development of inflammation and fibrosis.

6.

investors.chemomab.com

investors.chemomab.com/About-Nebokitug-CM-101

About Nebokitug (CM-101) - Chemomab Investor Relations

In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to ...

7.

gut.bmj.com

gut.bmj.com/content/74/Suppl_1/A22.2.full

O33 CM101, a novel monoclonal antibody targeting ...

The objective of this phase 2 study is to evaluate the safety, tolerability, and biological activities of CM-101 in patients with primary sclerosing cholangitis ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38822943/

Rationale and Results from Three CM-101 Phase 1 Studies

CM-101 is a humanized monoclonal antibody that neutralizes CCL24 to attenuate inflammation and fibrosis in preclinical models.