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Phase 2 N=98 Randomized Quadruple-blind Treatment

A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis

Atopic Dermatitis

Enrolled (actual)
98
Serious AEs
1.0%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) — 7.3; 7.26; 4.27; 4.6 score on a scale — p== 0.249

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ZPL-3893787 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ziarco Pharma Ltd
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)
7.3; 7.26; 4.27; 4.6; -3.03; -2.66 = 0.249
SECONDARY
Change From Baseline in Eczema Area and Severity Index (EASI) Score
21.39; 20.44; 10.67; 15.06; -10.72; -5.38 = 0.01 sig

Summary

This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

Eligibility Criteria

Inclusion Criteria

Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

Eczema Area and Severity Index (EASI) of ≥12 and 48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study

Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.

Have an active skin infection or any other clinically apparent infections.

Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.

Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.

Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.

Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02424253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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