Trial reportInternational journal of rheumatic diseases2026
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Firsekibart in Gout: A Phase Ib/II Clinical Trial.
Trial report in International journal of rheumatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05328531 (The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout), which is not on this map. Not yet cited in PubMed.
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The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout
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26 authors.
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Abstract
aimThis Phase Ib/II study aimed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Firsekibart in the treatment of gout flares.
methodsPhase 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.
resultsAs 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 T
conclusionA 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.
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