drugset / Trial / NCT04773600

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

Phase 3 Completed 683 enrolled Arcutis Biotherapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.

Timeline

Start: 2021-02-24
Primary completion: 2022-09-29
Completion: 2022-09-29

Outcome

Met primary endpoint

registry analysis (superiority test); Roflumilast Cream 0.15% vs Vehicle Cream; p <0.0001; Odds Ratio (OR) 3.19 (95% CI 1.962 to 5.183); Cochran-Mantel-Haenszel NCT04773600 ↗

paper Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). PMID 39292443 ↗

release “INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001” arcutis.com ↗

release “Both studies met the primary endpoint of IGA Success” arcutis.com ↗

release “both INTEGUMENT-1 and -2 studies met their primary endpoint of IGA Success” arcutis.com ↗

release “INTEGUMENT-2: 28.9% ZORYVE cream vs. 12.0% vehicle, P<0.0001” arcutis.com ↗

Publications

Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	0.15 %	Topical