eligibility_summary
Adults 18–70 (KPS ≥60, survival >6 mo) post-allo HSCT with NIH moderate–severe cGVHD, 2–5 prior systemic lines, stable steroids/immunosuppressants ≥2 wks, adequate organ function, start protocol control drug Day 1, contraception, consent. Exclude: malignancy ≤3 yrs, active aGVHD, serious lung disease or infection, PTLD or relapse, graft failure <6 mo or ≥2 allo-HSCTs, recent JAK/BTK, cannot take oral meds, substance/psychiatric issues, severe illness/allergy, recent trial, PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized, open-label trial in moderate–severe chronic GVHD (≥3rd line) compares rovadicitinib vs investigator’s choice. Rovadicitinib: small-molecule dual JAK1/2 and ROCK2 inhibitor, blocks JAK-STAT cytokine signaling (e.g., IL-2, IL-6, IFN) to reduce inflammatory effector activity, and inhibits ROCK2 to modulate Th17/Tfh differentiation and profibrotic signaling. Comparator options: imatinib (small-molecule TKI inhibiting BCR-ABL, PDGFR, c-KIT, antifibrotic via PDGF blockade), methotrexate (antifolate antimetabolite/DHFR inhibitor, immunosuppressant), mycophenolate mofetil (IMPDH inhibitor, blocks guanine synthesis in T/B lymphocytes), rituximab (anti-CD20 monoclonal antibody, B-cell depletion via ADCC/CDC). Targets: T cells (Th1/Th17/Tfh), B cells (CD20+), NK cells, fibroblasts/stromal PDGFR, JAK-STAT and ROCK2 fibrogenic pathways. Primary aim: superior ORR at week 24.