Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

Phase 2 Completed 104 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.

Timeline

Start: 2020-12-21
Primary completion: 2021-08-18
Completion: 2021-08-18

Outcome

Met primary endpoint

registry analysis (superiority test); AD Vehicle Once Daily (QD) vs AD PF-07038124 0.01% QD; p = 0.0004; Mean Difference (Final Values) -39.4 (90% CI -58.76 to -20.12); t-test, 1 sided NCT04664153 ↗

registry analysis (superiority test); Psoriasis Vehicle QD vs Psoriasis PF-07038124 0.01% QD; p <0.0001; Mean Difference (Final Values) -4.9 (90% CI -7.02 to -2.77); t-test, 1 sided NCT04664153 ↗

Publications

Eichenfield LF, Tarabar S, Forman S, Garcia-Bello A, Feng G, Fetterly G, Mahling P, Peeva E, Vincent MS, Chandra DE. Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Feb 1;160(2):156-163. doi: 10.1001/jamadermatol.2023.4990.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IDREBORMILAST	Small molecule	0.01 %	Topical