Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

NCT04853992 ↗

Phase 2 Completed 20 enrolled JW Pharmaceutical LEO Pharma · collab

RandomizedCrossoverDouble-blindTreatment

Summary

Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria

Timeline

Start: 2021-05-10
Primary completion: 2022-07-08
Completion: 2022-07-11

Outcome

Missed primary endpoint

paper did not demonstrate significant improvements vs. placebo in the primary endpoint PMID 38308655 ↗

registry analysis (superiority test); Active vs Placebo; p = 0.277; Mean Difference (Net) -0.58 (95% CI -1.69 to 0.53); Mixed Models Analysis NCT04853992 ↗

Publications

Grekowitz E, Metz M, Altrichter S, Bauer A, Brockow K, Heine G, Lionnet L, Saday KK, Hultsch T, Soerensen OE, Maurer M. Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial. Br J Dermatol. 2024 May 17;190(6):825-835. doi: 10.1093/bjd/ljae038.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Izuforant	Small molecule	100 mg	Oral