Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Scle… (NCT06210945) | Clinical Trial Compass
SuspendedPhase 2
Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
Stopped: pending financial resources
United States45 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Endothelin receptor antagonist, such as macitentan, bosentan, ambrisentan
✓. Phosphodiesterase type 5 inhibitors, such as sildenafil and tadalafil.
Exclusion criteria
✕. 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.
What they're measuring
1
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)
. 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.