A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

Phase 3 Completed 351 enrolled Almirall, S.A. Athenex, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

Timeline

Start: 2017-09-18
Primary completion: 2018-05-03
Completion: 2019-04-24

Outcome

Met primary endpoint

registry NUMBER KX2-391 Ointment 1%: 44 percentage of participants NCT03285477 ↗

registry Placebo vs KX2-391 Ointment 1%; p <0.0001 NCT03285477 ↗

paper difference, 40 percentage points; 95% confidence interval [CI], 32 to 47; P<0.001 PMID 33567191 ↗

paper tirbanibulin 1% ointment applied once daily for 5 days was superior to vehicle for the treatment of actinic keratosis at 2 months PMID 33567191 ↗

release “Both Phase III studies, KX01-AK-003 and KX01-AK-004, achieved their primary endpoint” almirall.com ↗

Publications

Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tirbanibulin	Small molecule	1 %	Topical