CM-101 for Primary Sclerosing Cholangitis

Recruiting at 51 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

68 Participants Needed

Trial Summary

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.

How does the drug CM-101 differ from other treatments for primary sclerosing cholangitis?

CM-101 is unique because it is being tested as a potential treatment for primary sclerosing cholangitis, a condition for which no effective medical therapy currently exists. Unlike existing treatments that focus on symptom management or complications, CM-101 may offer a novel approach to addressing the underlying disease. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a new antibody treatment for adults with Primary Sclerosing Cholangitis (PSC). The treatment aims to block a molecule that causes inflammation, potentially reducing liver damage.

Research Team

Matthew Frankel, MD

Principal Investigator

ChemomAb Ltd.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combined therapy with azathioprine, prednisolone, and ursodiol in patients with primary sclerosing cholangitis. A case series. [2019]

2. Puerto Rico pubmed.ncbi.nlm.nih.gov

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Endpoints in the design of clinical trials for primary sclerosing cholangitis. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[A clinical and pathological analysis of 22 cases of primary sclerosing cholangitis]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Primary sclerosing cholangitis. [2019]