eligibility_summary
Adults ≥18, HLA‑B27+, r‑ or nr‑axSpA per ASAS/modified NY, active disease (ASDAS‑CRP ≥2.1 and back pain NRS ≥4), objective inflammation: nr needs MRI sacroiliitis and/or hsCRP >1.5×ULN, r needs hsCRP >1.5×ULN, back pain ≥3 mo, onset <45, inadequate/contra/intolerant to NSAIDs, prior b/tsDMARD failure allowed, stable meds, contraception. Exclude: major infections (TB/HIV/HBV/HCV), recent vaccines/prohibited meds, abnormal labs, IBD flare/acute uveitis, serious comorbidity, other autoimmune arthritis, psych/substance issues, malignancy <5y, pregnancy/breastfeeding, MRI contraindication, drug allergy, recent major surgery, recent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study drug: BCD-180, an intravenous biologic (monoclonal antibody) that binds TRBV9 (T-cell receptor beta variable 9) to selectively target TRBV9-expressing T lymphocytes, aiming to modulate or deplete these cells and dampen TCR-driven pathogenic T-cell responses in axial spondyloarthritis. Comparators: placebo and adalimumab, a subcutaneous fully human monoclonal antibody anti–TNF-alpha that neutralizes TNF-alpha signaling to reduce inflammatory cascades. Cells/pathways targeted: TRBV9+ T cells and TCR signaling (BCD-180), TNF-alpha pathway impacting inflammatory cells (e.g., T cells, macrophages) and enthesis/synovial inflammation (adalimumab). Phase 3, double-blind, all switch to BCD-180 after primary endpoint.