What side effects are associated with this type of intervention?

Common treatments for Primary Sclerosing Cholangitis (PSC) include ursodeoxycholic acid (UDCA), which can cause side effects such as weight gain, diarrhea, and hair thinning. Monoclonal antibodies like CM-101, which target and inhibit CCL24 to reduce inflammation and fibrosis, are being studied for their potential benefits. Known side effects of monoclonal antibody treatments can include infusion reactions (fever, chills, rash), increased risk of infections, and potential liver enzyme abnormalities. Other treatments for PSC, such as immunosuppressants, may lead to side effects like increased susceptibility to infections, gastrointestinal disturbances, and bone marrow suppression.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Primary Sclerosing Cholangitis (PSC). Current management primarily focuses on symptom relief and managing complications. Ursodeoxycholic acid (UDCA) has been used off-label to improve liver enzyme levels, but its efficacy in altering disease progression is unclear. CM-101, an anti-human CCL24 monoclonal antibody, is being studied for its potential to reduce inflammation and fibrosis in PSC, representing a novel therapeutic approach targeting the underlying pathophysiology of the disease.

What other types of research exist?

Promising novel alternatives to CM-101 for PSC patients include: 1) Nivolumab, an immune checkpoint inhibitor that has shown efficacy in advanced biliary tract cancers, potentially applicable to PSC due to its anti-inflammatory properties. 2) Pemigatinib, a fibroblast growth factor receptor (FGFR) inhibitor, which has demonstrated activity in cholangiocarcinoma and may offer benefits in PSC by targeting fibrosis pathways. 3) Lenvatinib, a multi-kinase inhibitor, combined with transarterial chemoembolization, has shown promise in hepatocellular carcinoma and could be considered for its anti-fibrotic effects in PSC.

← Back to Search

Monoclonal Antibodies

CM-101 for Primary Sclerosing Cholangitis

Phase 2

Waitlist Available

Research Sponsored by ChemomAb Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects receiving concomitant medications must be stable ≥12 weeks prior to randomization (including stable dose)

Subjects receiving Ursodeoxycholic acid (UDCA) must receive a stable dose for ≥12 weeks prior to Screening

Must not have

Subjects showing deleterious effects of alcohol abuse or unexplained weight loss during the 24 weeks prior to randomization

Subjects who have gone through major surgical procedure within 60 days of randomization or have had prior organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the introduction of antibodies into the body; however, specific side effects for CM-101 are not detailed here and would be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My medication doses have been stable for at least 12 weeks.

Select...

I have been taking a consistent dose of UDCA for at least 12 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have been diagnosed with liver cirrhosis.

Select...

I am planning to have or have had a liver transplant.

Select...

I am not taking any medications that are not allowed in the study.

Select...

I have a history of severe liver problems, including cirrhosis or liver failure.

Select...

I have or am suspected to have cholangiocarcinoma.

Select...

I have Gilbert's syndrome or had high levels of indirect bilirubin.

Select...

I have severe liver issues with complications like varices or ascites.

Select...

I have had a severe colitis flare-up needing more treatment or hospitalization in the last 3 months.

Select...

My INR is over 1.5 and doesn't normalize with vitamin K, and I'm not on blood thinners.

Select...

I have small duct primary sclerosing cholangitis without large duct involvement.

Select...

I have not received a live vaccine in the last 30 days.

Select...

I currently have an active infection.

Select...

I have had a stable biliary condition for at least 24 weeks without needing intervention.

Select...

I have chronic hepatitis B or C, or tested positive for hepatitis B.

Select...

I am not pregnant or breastfeeding.

Select...

I have another liver condition besides my current diagnosis.

Select...

I haven't taken any biologic treatments like anti-TNF or anti-integrin antibodies in the last 24 weeks.

Select...

I have no active cancer except for certain skin cancers or treated cervical cancer without recurrence in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety-related endpoints - number of participants with treatment-emergent adverse events (TEAEs)

Secondary study objectives

ALP response rates

Alkaline phosphate (ALP) levels

Assessment of Pharmacodynamic (PD) parameters - IgG1 levels

+19 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Anti-human CCL24 monoclonal antibody (CM-101)Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Placebo - intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-human CCL24 monoclonal antibody (CM-101)

2017

Completed Phase 1

~40

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Primary Sclerosing Cholangitis (PSC) treatments often aim to reduce inflammation and fibrosis in the bile ducts. CM-101, an anti-human CCL24 monoclonal antibody, targets and inhibits CCL24, a chemokine involved in the recruitment of inflammatory cells and the promotion of fibrosis. By blocking CCL24, CM-101 reduces inflammation and fibrosis, potentially slowing disease progression. Other treatments, such as ursodeoxycholic acid (UDCA), work by improving bile flow and reducing liver enzyme levels, although their efficacy in altering disease progression is limited. These treatments are crucial for PSC patients as they address the underlying inflammatory and fibrotic processes, aiming to preserve liver function and improve quality of life.

Effects of human amnion-derived mesenchymal stem cells and conditioned medium in rats with sclerosing cholangitis.