Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
NCT06210945 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-04-15
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
Interventions
- DRUG
-
10 mg/kg CM-101
10 mg/kg CM-101
- DRUG
-
Placebo
Sponsors & Collaborators
-
ChemomAb Ltd.
lead INDUSTRY
Principal Investigators
-
Matthew Frankel, MD · ChemomAb Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
NCT01405820 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
NCT05214794 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
NCT02861014 ·Status: COMPLETED ·Phase: PHASE3
-
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
NCT00813969 ·Status: COMPLETED ·Phase: PHASE1
-
An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
NCT05663853 ·Status: COMPLETED
-
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
NCT06675955 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
NCT05064436 ·Status: TERMINATED ·Phase: PHASE1
-
Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
NCT02797015 ·Status: COMPLETED ·Phase: PHASE1
-
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01707992 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
NCT00027300 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
NCT05704361 ·Status: RECRUITING ·Phase: PHASE1
-
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
NCT06617793 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
NCT00484536 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
NCT00223301 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis
NCT02427776 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
NCT06058091 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
NCT05080270 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Natalizumab Subcutaneous Immunogenicity and Safety Study
NCT02142192 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
NCT00087529 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
NCT05232825 ·Status: COMPLETED ·Phase: PHASE3
-
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
NCT00292253 ·Status: COMPLETED ·Phase: PHASE3
-
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01808482 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
NCT06220201 ·Status: RECRUITING ·Phase: PHASE1
-
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
NCT02034188 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT06735248 ·Status: RECRUITING ·Phase: PHASE2