eligibility_summary
Eligibility: Adults (≥18) with diffuse cutaneous systemic sclerosis from BV201708 at St. Joseph’s, ≥4-point mRSS worsening from week-48 EOT, able to consent. Exclusions: FVC<40%/DLCO<30%, pregnancy/no contraception, significant pulmonary hypertension or cardiac disease, active infection (HIV, TB, HBV/HCV), uncontrolled comorbidities/cancer, ≥grade 2 neuropathy, hypersensitivity, poor compliance, labs (ANC<2.0, Hgb<85, Plt<100, AST/ALT>2×ULN), recent trial, rituximab (<4 mo), live vaccine (<4 wk), or PML.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Brentuximab vedotin (ADCETRIS, SGN‑35), a CD30‑directed antibody‑drug conjugate (anti‑CD30 IgG1 linked to the microtubule inhibitor MMAE), IV 0.6 mg/kg every 3 weeks for up to 48 weeks (open‑label extension in relapsed early dcSSc). Mechanism: binds CD30 on activated lymphocytes, internalizes, and releases MMAE in lysosomes to disrupt microtubules and induce apoptosis, depleting CD30+ inflammatory cells and dampening immune‑driven inflammation to reduce/limit fibrosis. Targets/cells/pathways: CD30 (TNFRSF8) pathway, CD30+ T cells (activated effector/memory, some B/NK cells), cutaneous CD30+ infiltrates (skin IHC). Exploratory biomarkers: ESR/CRP, CRISS, HAQ‑DI, aim is immunomodulation to indirectly curb fibroblast activation and tissue fibrosis. Standard SSc immunosuppressants may continue.