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

Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)

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 Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: LEO 29102; Drug: LEO 29102 Cream Vehicle

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Bonn, Germany, 53105
    • Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
  • Essen, Germany, 45122
    • Universitätshautklinik Essen
  • Frankfurt/Main, Germany, 60590
    • Department of Dermatology, Johann Wolfgang Goethe-University
  • Gera, Germany, 07584
    • SRH Wald-Klinikum Gera gGmbH
  • Hamburg, Germany, 20246
    • Clinical Trial Center North
  • Hannover, Germany, 30449
    • Medizinische Hochschule Hannover
  • Münster, Germany, 48149
    • Universitätshautklinik Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 29102 2,5 mg/g cream	Drug: LEO 29102; Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV
Placebo Comparator: LEO 29102 Cream Vehicle	Drug: LEO 29102 Cream Vehicle; Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK profile - Cohort I, II, III	Cmax, AUC, Tmax	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	14 Days
PK profile - Cohort IV	Cmax, AUC, Tmax	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.	49 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	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)	10 Days for cohort I, 42 days for cohort IV, subgroup 2

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Diamant Thaci, MD, Goethe University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimated): October 6, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: LEO 29102-C26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO