Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Conditions
Brief summary
Mean change from Baseline to Week 24 on the modified Rodnan skin score (mRSS) in each study arm.
Detailed description
Incidence, seriousness, and severity of AEs, TEAEs, SAEs, and treatment-related adverse events (TRAEs), Clinically significant findings on physical examination, vital signs, and clinical laboratory tests., Proportion of participants in each arm with a gene signature response on skin biopsy at Week 12., Sparse and serial PK profiles after MTX-474 administration to participants will be evaluated by population PK, based on drug concentrations in serum over time. For a subset of participants with serial PK sampling, noncompartmental PK parameters (CL, t1/2, and AUCs) will be reported.
Interventions
Sponsors
Mediar Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from Baseline to Week 24 on the modified Rodnan skin score (mRSS) in each study arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, seriousness, and severity of AEs, TEAEs, SAEs, and treatment-related adverse events (TRAEs), Clinically significant findings on physical examination, vital signs, and clinical laboratory tests., Proportion of participants in each arm with a gene signature response on skin biopsy at Week 12., Sparse and serial PK profiles after MTX-474 administration to participants will be evaluated by population PK, based on drug concentrations in serum over time. For a subset of participants with serial PK sampling, noncompartmental PK parameters (CL, t1/2, and AUCs) will be reported. | — |
Outcome results
None listed