A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis

Summary

A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis

Timeline

Start

2016-06

Primary completion

2017-03-01

Completion

2017-03-01

Outcome

Mixed primary results

registry analysis (superiority test); Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo; p = 0.0275; Mean Difference (Net) -37.60 (90% CI -69.53 to -5.66); ANCOVA; NCT02795832 ↗

registry analysis (superiority test); Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo; p = 0.1284; Mean Difference (Net) -11.72 (90% CI -28.85 to 5.51); ANCOVA; NCT02795832 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-5212372	Small molecule	1 %	Topical

Indications