Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

NCT06210945 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: CM-101-SSC-203
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)

  Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)

  24-weeks

Secondary Outcomes (12)

• To evaluate change from Baseline in serum biological markers - growth factors and cytokines

  24 weeks

• To evaluate change from Baseline in serum biological markers - adhesion molecules

  24 weeks

• To evaluate change from Baseline in serum biological markers - vascular

  24 weeks

• To evaluate change from Baseline in serum biological markers - lung injury

  24 weeks

• To evaluate change from Baseline in serum biological markers - surfactant protein D

  24 weeks

Study Arms (2)

CM-101

EXPERIMENTAL

CM-101 will be administered

Drug: 10 mg/kg CM-101

Placebo

PLACEBO COMPARATOR

Placebo will be administered

Drug: Placebo

Interventions

10 mg/kg CM-101 DRUG

10 mg/kg CM-101

CM-101

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of systemic sclerosis based on the 2013 ACR-EULAR Classification Criteria for SSc with a disease duration of ≤7 years as defined by the date of onset of the first non-Raynaud's symptom. Systemic sclerosis may be of limited or diffuse type.
• A serum level of CCL24 ≥400 pg/mL at Screening
• Presence of one of the below confirming active disease at Screening:
• a. Skin involvement with mRSS ≥15 b. Presence of interstitial lung disease at Screening, evidenced by \>10% involvement at HRCT (historic HRCT performed within 12 weeks of Screening may be used if the images are available to be sent to the central reader) and at least one of the following at Screening: i. C-reactive protein (CRP) ≥6 mg/L, or ii. Erythrocyte sedimentation rate (ESR) ≥28 mm/hr, or iii. Platelet count ≥(330,000/microliter), or iv. Serum level of CCL24 ≥1,000 pg/mL c. Current digital ulcer and at least one of the following at Screening: i. CRP ≥6 mg/L, or ii. ESR ≥28 mm/hr, or iii. Platelet count ≥330,000/μL), or iv. Serum level of CCL24 ≥1,000 pg/mL
• If under active immunosuppressive treatment for SSc, treatment must be stable
• ≥12 weeks before Screening with intention to continue with no change in dose from Screening through the end of study. Hydroxychloroquine (or similar antimalarial such as chloroquine) use is allowed and may be combined with up to one of the following:
• Methotrexate (maximum dose 25 mg/week),
• Azathioprine (maximum dose 200 mg/day),
• Mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (maximum dose 2 g/dayMMF or equivalent).
• Oral corticosteroids of prednisone (or equivalent) ≤10 mg/day are allowed but not required and if present, must be stable for 30 days prior to Screening.
• If under treatment with the following, treatment must be stable for ≥8 weeks before Screening with the intention to continue with no change in dose from Screening through the end of study:
• Endothelin receptor antagonist, such as macitentan, bosentan, ambrisentan
• Phosphodiesterase type 5 inhibitors, such as sildenafil and tadalafil.
• Negative serum pregnancy test for biologically female patients of childbearing potential
• Men and women with reproductive potential are required to use a highly effective means of contraception through the course of the study

You may not qualify if:

• Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.
• Rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, undifferentiated connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren's syndrome, and eosinophilic myalgia syndrome when classification or diagnostic criteria for those diseases are met.
• Systemic sclerosis with end-stage organ involvement at Screening, including:
• Currently or anticipating placement on an organ transplantation list, or has received an organ transplant
• Renal crisis within 6 months before Screening
• Interstitial lung disease with FVC% \< 45 or requiring constant oxygen therapy. Oxygen used to aid sleep or exercise is allowed.
• Pulmonary hypertension requiring constant oxygen therapy or continuous intravenous treatment with prostaglandins. Oxygen used to aid sleep or exercise is allowed.
• Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Screening.
• Use of following treatment(s) during the study or within the times noted:
• Within 26 weeks prior to Screening: cyclophosphamide, rituximab
• Within 12 weeks prior to Screening: tocilizumab, thalidomide, cyclosporine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib)
• Within 6 weeks prior to Screening: ultraviolet (UV) phototherapy
• Within 30 days prior to Screening: systemic corticosteroids at doses greater than 10mg/day prednisone or equivalent
• Other monoclonal antibodies not listed, please consult with the Medical Monitor regarding appropriate discontinuation period
• Anticipated to require the following treatments during the study: cell depleting therapy, chlorambucil, total lymphoid radiation, anti-thymocyte globulin, plasmapheresis, extra-corporeal photopheresis or bone marrow transplant. If prior use, consult Medical Monitor.

Sponsors & Collaborators

• ChemomAb Ltd.: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

streptococcal polysaccharide type III group B

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin 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: August 22, 2023
• First Posted: January 18, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)