Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.

Phase 1TerminatedNCT01447758

LEO Pharma58 enrolled

Overview

The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis of AD defined according to Hanifin and Rajka. 2. Investigator Global Assessment scored as mild (2) to severe (4) AD. 3. At screening, AD lesions amenable for treatment involving 10% to \< 25% (Cohort I), 25% to \< 50% (Cohort II), 50% to 100% (Cohort III) and 10% to \< 50% (Cohort IV) of the total BSA. 4. On Day -1, AD lesions amenable for treatment involving 10% to \< 28% (Cohort I), 25% to \< 55% (Cohort II), 50% to 100% (Cohort III) and 10% to \< 55% (Cohort IV) of the total BSA. 5. Adult male or female subjects, aged 18 to 65 years, inclusive.

Locations (8)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn

Bonn, Germany

Universitätshautklinik Essen

Essen, Germany

Department of Dermatology, Johann Wolfgang Goethe-University

Frankfurt am Main, Germany

SRH Wald-Klinikum Gera gGmbH

Gera, Germany

Clinical Trial Center North

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätshautklinik Münster

Münster, Germany

Outcomes

Primary Outcomes

PK profile - Cohort I, II, III

Cmax, AUC, Tmax

Time frame: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)

Tolerability and safety of LEO 29102 cream - Cohort I, II, III

Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination

Time frame: 14 Days

PK profile - Cohort IV

Cmax, AUC, Tmax

Time frame: Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42

Tolerability and safety of LEO 29102 cream - Cohort IV

Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.

Time frame: 49 Days

Secondary Outcomes

Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1)

Time frame: 10 Days for cohort II; 42 days for cohort IV, subgroup 1

Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)

Time frame: 10 Days for cohort I, 42 days for cohort IV, subgroup 2