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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05198557
Eligibility Criteria:
Inclusion Criteria:
Additional screening criteria check may apply for qualification:
1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
2. Skin thickening score based on the mRTSS between 10 and 22 inclusive.
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
1. Pulmonary hypertension associated with SSc.
2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
3. Finding of inadequate respiratory reserve capacity.
4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
5. Presence of a clinically significant active infection requiring antimicrobial therapy.
6. A past history of cancer.
7. Past history of a recurrent, clinically significant infection.
8. Past history of severe allergy or anaphylactic reaction to a biologic drug product.
9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT05198557
Study Brief:
Protocol Section:
NCT05198557