Phase 2
Completed N=53
A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02795832 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Percent Change From Baseline in EASI Score in Cohort 3 — -34.24; -34.29; -34.04; -31.03 percent change from baseline in EASI — p=0.5016
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in EASI Score in Cohort 3 |
-34.24; -34.29; -34.04; -31.03; -34.04; -15.77 | 0.5016 |
| PRIMARY Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case |
-16.68; -4.96; -27.36; -21.41; -32.50; -26.49 | 0.1284 |
| SECONDARY Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3 |
7; 3; 13; 7; 3; 0 | 0.4789 |
| SECONDARY Percentage of Responders on Investigators Global Assessment in Cohort 3 |
5.0; 10.0 | 0.500 |
| SECONDARY Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3 |
-2.46; -2.54 | 0.5233 |
| SECONDARY Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3 |
4; 1; 5; 1; 7; 4 | 0.2455 |
| SECONDARY Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3 |
-6.26; -3.61 | 0.2812 |
Eligibility Criteria
Inclusion Criteria
- Healthy males or females, aged between 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
or
Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
For Atopic Dermatitis Patients:
Eczema Area and Severity Index (EASI) of ≥9 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 concomitant skin disease or infection (e.g. acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
- Have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g. immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the study. All other biologics should not have been used within 3 months of the start of study.
- Have received systemic corticosteroids (e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the study. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
- Patients treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting study; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
Data sourced from ClinicalTrials.gov (NCT02795832). 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. Informational only — not medical advice.