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Primary Sclerosing CholangitisPhase 2NCT04595825

CM-101 in PSC Patients -The SPRING Study

A Phase 2 study testing Anti-human CCL24 monoclonal antibody (CM-101) in people with Primary Sclerosing Cholangitis, run by ChemomAb Ltd. at 33 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Sclerosing Cholangitis
What is being tested?
Anti-human CCL24 monoclonal antibody (CM-101)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
33 sitesin 5 countries
Study dates
1 Oct 2020to 10 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with diagnosis of large duct PSC of more than 24 weeks' duration
  • Subjects that have no significant clinical concern for cholangiocarcinoma based on clinical, laboratory or imaging findings
  • Subjects with serum Alkaline phosphatase (ALP) greater than 1.5 × Upper limit of normal (ULN) in Screening blood tests.
  • Subjects receiving Ursodeoxycholic acid (UDCA) must receive a stable dose for ≥12 weeks prior to Screening
  • Subjects with concomitant inflammatory bowel disease (IBD) is allowed but not required, and must meet the following stability criteria.
  • Subjects with ulcerative colitis: Must be either in remission or have mild disease. Must have recent colonoscopy with biopsy confirming no dysplasia or colorectal cancer or history of colectomy.
Show all 11Show fewer
  • Subjects with Crohn's Disease must be in remission as defined by a Crohn's Disease Activity Index (CDAI) < 150.
  • Subjects receiving concomitant medication for IBD, dose must be stable ≥12 weeks prior to screening and dose should remain stable during DB portion of the study
  • Subjects receiving concomitant medication for their PSC must be on stable therapy ≥12 weeks prior to randomization and plan to remain on that stable dose during the DB portion of the study
  • Female subjects of childbearing potential, must have a negative serum pregnancy test prior to starting study treatment and must have agree to highly effective method of contraception from the Screening Visit throughout the study period including 18 weeks post last dose
  • Male subjects, if not vasectomized, must agree to use barrier contraception from screening through to study completion and for 90 days from the last dose of study drug

Who cannot join

  • Subjects with presence of documented secondary sclerosing cholangitis on prior clinical investigations
  • Subjects with presence of competing etiology of liver disease.
  • Subjects with possible overlap syndrome with autoimmune hepatitis are excluded if the Investigator considers autoimmune hepatitis as the predominant liver injury
  • Subjects with small duct PSC in the absence of large duct disease
  • Subjects with percutaneous biliary drain or bile duct stent or subjects who had required biliary drainage within 12 weeks of Screening
  • Subjects that have undergone prior biliary surgery other than those who at the time of screening are more than 6 weeks after cholecystectomy without surgical complications
Show all 38Show fewer
  • Subjects with evidence of liver cirrhosis, as determined by local transient elastography values of ≥ 14.4 kPa obtained during the Screening period. In case of a fibrosis staging discrepancy between a recent (≤ 12 months) liver biopsy staging and the transient elastography results, eligibility will be based on the liver biopsy staging.
  • History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C), and/or hepatic decompensation including ascites, encephalopathy, or variceal bleeding
  • Subjects who have undergone or are planned for liver transplantation or with current model of end stage liver disease
  • Subjects with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) values > 5 × ULN as determined at Screening
  • Subjects who show 'clinically significant' lab changes at Screening
  • Subjects with serum total bilirubin values > 3 × ULN at Screening
  • Subjects with known Gilbert's syndrome or a history of elevations in unconjugated (indirect) bilirubin >ULN
  • Subjects with international normalized ratio (INR) >1.5 which does not correct on vitamin K replacement, in the absence of anticoagulants
  • Subjects with serum creatinine > 1.4 mg/dL (123 μmol/L) and/or a platelet count < 100 × 109 /L
  • Subjects with history of cholangiocarcinoma or a high clinical suspicion for cholangiocarcinoma
  • Subjects with elevated cancer antigen 19-9 (Ca 19-9) value (> 129 U/mL) within 12 months prior to Screening unless Ca 19-9 levels have been stable and clinical evaluation and repeated Magnetic resonance imaging (MRI) within the same time period has not provided evidence of cholangiocarcinoma
  • Subjects with a prior biliary stricture necessitating intervention should be stable for ≥ 24 weeks prior to randomization without intervention, or episode of cholangitis, and should show a low level of clinical suspicion of cholangiocarcinoma
  • Subjects with current known portal hypertension with complications, including known gastric or large esophageal varices, poorly controlled or diuretic resistant ascites, history of variceal bleeds, or related therapeutic or prophylactic interventions
  • Subjects with active malignancy (diagnosed and/or treated within 3 years of randomization), other than:
  • adequately treated non-metastatic basal cell skin cancer
  • squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to randomization
  • history of cervical carcinoma in situ that has been adequately treated and that has not recurred.
  • Subjects with a 'clinically significant' (as judged by the Investigator) unexplained weight loss during the 24 weeks prior to randomization
  • Subjects showing deleterious effects of alcohol abuse or that consume excessive amounts of alcohol
  • Subjects with known or suspected acute cholangitis in the 90 days prior to randomization, including cholangitis treated with antibiotics within the 90 days
  • Subjects experiencing flare in colitis activity within 90 days of randomization requiring intensification of therapy beyond baseline maintenance treatment or use of oral prednisone > 10 mg/day (or equivalent), start or dose change of biologics ≤ 12 weeks before screening and or hospitalization for colitis within 90 days of randomization
  • Subjects treated with or who are expected to begin treatment with fenofibrate or other fibrates or subjects who had a change in dose within 24 weeks of Screening, or subjects who are not planned to remain on a stable dose throughout the DB portion of the study
  • Subjects that use any prohibited medication
  • Subjects who have a known history of hypersensitivity reaction to CHO-derived antibodies, CM-101, or any of the formulation excipients
  • Subjects with known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or that have positive hepatitis B surface antigen (HBSAg) at Screening
  • Subjects with evidence of an active infection during the Screening period
  • Subjects with any identified congenital or acquired immune-deficiency
  • Subjects who have gone through major surgical procedure within 60 days of randomization or have had prior organ transplantation
  • Subjects who have received a live/attenuated vaccine within 30 days of study randomization
  • Female subjects who are pregnant or breast- feeding
  • Subjects that have participated in an investigational trial of a drug or device either within 60 days of randomization; or where the study drug half-life is greater than 12 days, at least 5 half-lives need to have passed from the last dose of investigational drug prior to randomization
  • Subjects with any other conditions, clinically significant disorders, or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing and study requirements

Trial locations and contacts

33 sites in 5 countries.

33 sites in 5 countries

Israel10 sites

  • Shamir Medical Center (Assaf Harofeh) - site P28

    Be’er Ya‘aqov

  • Soroka MC - site P23

    Beersheba

  • Carmel - site P27

    Haifa

  • Rambam MC - site P22

    Haifa

  • Hadassah Ein Kereme - site P21

    Jerusalem, 91120

  • Shaarei Tszedek Medical Center - site P29

    Jerusalem

  • Galilee Medical Center - site P24

    Nahariya

  • EMMS Holy Family Nazareth Hospital - site P26

    Nazareth

  • Assuta Medical Center - site P31

    Tel Aviv

  • Tel-Aviv Sourasky Medical Center - site P30

    Tel Aviv

Other trials in Israel

United States8 sites

  • Massachusetts General Hospital - site P95

    Boston, Massachusetts, 02114

  • Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - Liver Center - site P81

    Boston, Massachusetts, 02215

  • Northwestern University - site P77

    Chicago, Illinois, 60611

  • Methodist Dallas Medical Center - site P72

    Dallas, Texas, 75203

  • Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park - site P82

    Germantown, Tennessee, 38138-1741

  • Scripps Clinic Torrey Pines - site P83

    La Jolla, California, 92037

  • Virginia Commonwealth - site P94

    Richmond, Virginia, 23284

  • UC Davis Health System - Midtown Ambulatory Care Center - site P79

    Sacramento, California, 95816-5202

Other trials in United States

United Kingdom8 sites

  • University Hospitals Birmingham NHS Foundation Trust - site P05

    Birmingham

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital - site P09

    Cambridge

  • NHS Greater Glasgow and Clyde - site P03

    Glasgow

  • Leeds Teaching Hospitals NHS Trust - site P08

    Leeds, WYK, LS9 7TF

  • King's College Hospital NHS Foundation Trust - site P04

    London

  • The Royal Free Hospital - site P01

    London

  • Oxford University Hospitals NHS Foundation Trust- site P11

    Oxford

  • Plymouth Hospitals NHS Trust - Derriford Hospital - site P07

    Plymouth

Other trials in United Kingdom

Spain4 sites

  • Hospital Clínic de Barcelona - site P67

    Barcelona, 8036

  • Hospital Universitario Ramón y Cajal - site P61

    Madrid, 28034

  • Hospital Universitari i Politècnic La Fe - site P64

    Valencia, 46026

  • Hospital Universitario Miguel Servet - site P65

    Zaragoza, 50009

Other trials in Spain

Germany3 sites

  • Klinikum der Johann Wolfgang Goethe-Universitaet - site P42

    Frankfurt am Main

  • Universitätsklinikum Hamburg-Eppendorf (UKE) - site P47

    Hamburg, 20246

  • Medizinische Hochschule Hannover (MHH) - site P41

    Hanover

Other trials in Germany

About this study

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)

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

Read the detailed description

This study will consist of a screening period, double-blind (DB) treatment period, open-label (OL) treatment period, and safety follow-up period. During the DB treatment period, subjects will receive 5 total dose administrations of study drug (investigational product - IP or placebo) once every 3 weeks (Q3W) for a coverage of 15 weeks. After completing the DB treatment period, subjects may elect to enroll in an OL treatment period. In the OL treatment period, subjects will receive a dose of IP Q3W for 11 administrations for a coverage of 33 weeks, resulting in a combined total coverage of up to 48 weeks.

Subjects who do not elect to continue treatment in the OL dosing period will undergo an End of Treatment (EOT)-DB visit at Week 15 (Day 105), a Safety Follow-up Call at Week 21 (Day 147), and an End of Study (EOS) visit at Week 27. Eligible subjects who continue treatment in the OL treatment period will receive CM-101 at either a 10 mg/kg or 20 mg/kg dose commencing at Week 15 (OL Treatment 1), and the subjects will undergo an EOT-OL visit at Week 48 (Day 336), a Safety Follow-up Call at Week 54 (Day 378), and an EOS visit at Week 60 (Day 420).

Being tested
Anti-human CCL24 monoclonal antibody (CM-101), Placebo
Keywords
Anti-fibrotic
Medical subject headings
Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-human CCL24 monoclonal antibody (CM-101)Biological

    Anti-human CCL24 monoclonal antibody (CM-101) 100 mg Intravenous Infusion over 60 minutes (±5 minutes)

  • PlaceboOther

    Placebo - intravenous infusion

Study groups in NCT04595825
Study groupRoleWhat they receive
Anti-human CCL24 monoclonal antibody (CM-101)ExperimentalAnti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
Receives: Biological: Anti-human CCL24 monoclonal antibody (CM-101)
PlaceboPlacebo comparatorPlacebo - intravenous infusion
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind)

    Number of subjects with treatment-emergent adverse events (any, related, serious, and severe) - Safety-related endpoint

    Measured: 15 week double-blind (DB) treatment period

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Open-label)

    Number of subjects with treatment-emergent adverse events (any, related, serious, and severe) - Safety-related endpoints

    Measured: 33 week open-label (OL) treatment period

Secondary outcomes (15)

  1. Number of Participants With Abnormal Vital Sign Changes (Double-blind)

    Number of subjects with Abnormal Vital Sign Changes - Safety-related endpoints

    Measured: 15 week double-blind (DB) treatment period

  2. Number of Participants With Abnormal Vital Sign Changes (Open-label)

    Number of subjects with abnormal vital sign changes - Safety-related endpoints

    Measured: 33 week open-label (OL) treatment period

  3. Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)

    Number of subjects with abnormal changes in Hematology, Clinical Chemistry, Coagulation Test, Lipid Test, and Urinalysis - Safety-related endpoints

    Measured: 15 week double-blind (DB) treatment period

  4. Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)

    Number of subjects with abnormal changes in Hematology, Clinical Chemistry, Coagulation Test, Lipid Test, and Urinalysis - Safety-related endpoints

    Measured: 33 week open-label (OL) treatment period

  5. Number of Participants With Infusion Site Reactions (Double-blind)

    Number of subjects with Infusion Site Reactions TEAEs - Safety-related endpoints

    Measured: 15 week double-blind (DB) treatment period

  6. Number of Participants With Infusion Site Reactions (Open-label)

    Number of subjects with Infusion Site Reactions TEAEs - Safety-related endpoints

    Measured: 33 week open-label (OL) treatment period

  7. Percent Change in Serum ALP Levels (Baseline Pop. Fibroscan <= 8.7 kPa)

    In subjects with baseline Fibroscan levels <= 8.7 kPa, the percentage change of serum ALP levels at 15 weeks

    Measured: Percent change from baseline to Week 15

  8. Percent Change in Serum ALP Levels (Baseline Pop. Fibroscan > 8.7 kPa)

    In subjects with baseline Fibroscan levels > 8.7 kPa, the percentage change of serum ALP levels at 15 weeks

    Measured: Percent change from baseline to Week 15

  9. Enhanced Liver Fibrosis (ELF) by Treatment Group (MiTT)

    The ELF™ test is a non-invasive blood test designed to evaluate liver fibrosis severity and predict the risk of progression to cirrhosis and liver-related events. The ELF score was validated in healthy control population and is only being evaluated in PSC as part of this clinical study.

    ELF measures 3 markers of liver fibrosis: 1) Hyaluronic Acid, 2) Type III Procollagen Amino-Terminal Peptide (PIIINP), 3) Tissue Inhibitor of Matrix Metalloproteinase 1 (TIMP-1). These markers combine to a unitless numeric ELF score using a validated algorithm, which reflects both fibrogenesis and fibrosis regression.

    The ELF score was interpreted using risk cut-offs established in other diseases to estimate the likelihood of progression to cirrhosis. There is no theoretical min or max for ELF score in PSC, but higher scores indicate greater fibrosis severity. Scores < 9.8 indicate mild to moderate fibrosis while scores >=9.8 suggest more severe fibrosis or cirrhosis.

    Measured: Change from Baseline through Week 15

  10. ALP Response Rates (<1.5 x ULN)

    Subjects with ALP response rates, defined as reduction of ALP to 1.5 x upper limit of normal (ULN)

    Measured: Change from baseline through Week 15

  11. ALP Response Rates (>= 20% Reduction)

    Subjects with ALP response rates, defined as reduction of ALP by greater than or equal to 20%

    Measured: Change from baseline through Week 15

  12. Percent Change in Liver Enzymes Levels (ALT)

    The percentage change at 15 weeks in liver enzyme (alanine aminotransferase [ALT]))

    Measured: Percent change from baseline through Week 15

  13. Percent Change in Liver Enzymes Levels (AST)

    The percentage change at 15 weeks in liver enzyme (aspartate aminotransferase [AST])

    Measured: Percent change from baseline through Week 15

  14. Percent Change in Liver Enzymes Levels (GGT)

    The percentage change at 15 weeks in liver enzyme (gamma glutamyl transferase [GGT])

    Measured: Percent change from baseline through Week 15

  15. Change in Liver Fibrosis Markers (PRO-C3)

    The mean change at 15 weeks in liver enzyme (pro-peptide of type collagen [PRO-C3])

    Measured: Change from baseline through Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start1 Oct 2020
  3. Primary completion10 Jan 2025
  4. Study completion10 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595825
Sponsor's protocol ID
CM-101-PSC-101
Status last verified
Jun 2026
First submitted
7 Oct 2020
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-human CCL24 monoclonal antibody (CM-101) in people with Primary Sclerosing Cholangitis, run by ChemomAb Ltd. at 33 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Israel, United States, United Kingdom, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind) (time frame: 15 week double-blind (DB) treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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