Int J Rheum Dis. 2026 Jul;29(7):e70785. doi: 10.1111/1756-185x.70785.
ABSTRACT
AIM: This Phase Ib/II study aimed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Firsekibart in the treatment of gout flares.
METHODS: Phase Ib part utilized an open-label, single-dose, dose-escalation design. Patients were enrolled and received a single subcutaneous injection of Firsekibart at a dose of 50, 100, or 195 mg. Phase II part was a multicenter, randomized, double-blind, parallel, positive-controlled study. Patients were assigned to receive either Firsekibart (100 or 195 mg) or Diprospan.
RESULTS: As of June 9, 2022, a total of 120 patients (Phase Ib N = 29, Phase II N = 91) received the study drugs. In Phase Ib, Firsekibart demonstrated dose-dependent efficacy. Firsekibart 50 mg treatment provided less pain relief compared to the 100 mg and 195 mg. In Phase II, the visual analogue scale (VAS) score decreased by 5.51 ± 1.56, 4.72 ± 1.56 and 4.94 ± 2.44 cm after 72 h in Firsekibart 195 mg, 100 mg and Diprospan groups, respectively. Firsekibart 195 mg treatment showed a more effective pain relief trend. The pharmacokinetic (PK) profile of serum Firsekibart exhibits typical characteristics of monoclonal antibodies, featuring slow absorption (median Tmax approximately 5.9-6.9 days), limited distribution (distributed volume approximately 8.0-12.1 L) and slow elimination (clearance approximately 9.2-11.5 mL/h). Safety of Firsekibart was favorable and comparable across doses and relative to Diprospan.
CONCLUSION: A single subcutaneous injection of Firsekibart is safe and well tolerated in the treatment of gout flares. It provides dose-dependent pain relief with favorable pharmacokinetic properties and potential for reducing the risk of gout flare recurrence.
TRAIL REGISTRATION: Trial Registration: ClinicalTrials.gov NCT05328531.
PMID:42498684 | DOI:10.1111/1756-185x.70785
