Safety and efficacy of the selective tyrosine kinase 2/Janus kinase 1 inhibitor TLL-018 in moderate to severe chronic spontaneous urticaria patients with inadequate response to H1 antihistamines: a ph
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- #chronic spontaneous urticaria
- #TYK2/JAK1 inhibitor
- #clinical trial
- TLL-018, a TYK2/JAK1 inhibitor, was studied for treating moderate-to-severe chronic spontaneous urticaria (CSU) in patients unresponsive to antihistamines.
- The phase Ib study was randomized, double-blind, and placebo-controlled, involving 41 patients receiving 10 mg, 30 mg TLL-018, or placebo (later switched to 20 mg TLL-018).
- Primary endpoint was safety; secondary endpoints included efficacy measures like Urticaria Activity Score (UAS7) and Dermatology Life Quality Index.
- At week 4, UAS7 improvements were significant in both TLL-018 dose groups compared to placebo.
- By week 12, over 50% of patients in all TLL-018 groups achieved UAS7 ≤ 6 or UAS7 = 0, indicating symptom control.
- Common adverse events included elevated creatine kinase, blood lipids, hyperglycemia, and urinary occult blood.
- TLL-018 was well-tolerated and effective for antihistamine-resistant CSU.