Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07472166
Eligibility Criteria:
Inclusion Criteria:
* 1\. Diagnosed with systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria 2. Classified as having diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy and Medsger 3. Disease duration of ≤ 36 months, calculated from the onset of the first non-Raynaud's phenomenon manifestation.
4\. Modified Rodnan Skin Score (mRSS) between 10 and 45 at the time of screening.
5\. Concurrent use of calcium channel blockers and phosphodiesterase-5 inhibitors for the treatment of Raynaud's phenomenon or digital ulcers was permitted.
6\. Subjects were aged 18 years and older
Exclusion Criteria:
* 1\. Presence of a rheumatic disease other than systemic sclerosis, except for fibromyalgia or scleroderma-associated myopathy.
2\. Evidence of any active infection, including active tuberculosis 3. Abnormal laboratory values at screening, including:
* Hemoglobin \<9 g/dL
* White blood cell count \<3.0 × 10⁹/L
* Absolute neutrophil count \<1.2 × 10⁹/L
* Platelet count \<100 × 10⁹/L
* Absolute lymphocyte count \<0.75 × 10⁹/L
* ALT or AST \>3× the upper limit of normal (ULN)
* Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m²
4\. Pulmonary function showing forced vital capacity (FVC) ≤ 50% predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% predicted.
5\. History of major surgery (including joint surgery) within 8 weeks prior to the screening visit.
6\. Use of oral corticosteroids 7. Diagnosis of latent TB at or within 30 days of screening. 8. Positive hepatitis B surface antigen or anti HCV test at or within 30 days of screening.
9\. Pregnant or breastfeeding women, females of childbearing potential who were unwilling or unable to use highly effective contraception during the study 10. History or evidence of malignancy 11. Receipt of a live or attenuated vaccine within 6 weeks prior to baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07472166
Study Brief:
Protocol Section:
NCT07472166