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

NCT01447758 | Terminated Phase 1

• 1 other identifier: LEO 29102-C26
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (2)

LEO 29102 2,5 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 Cream Vehicle

PLACEBO COMPARATOR

Drug: LEO 29102 Cream Vehicle

Interventions

LEO 29102 DRUG

Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV

LEO 29102 2,5 mg/g cream

LEO 29102 Cream Vehicle DRUG

Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV

LEO 29102 Cream Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of AD defined according to Hanifin and Rajka.
• Investigator Global Assessment scored as mild (2) to severe (4) AD.
• 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.
• 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.
• Adult male or female subjects, aged 18 to 65 years, inclusive.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (8)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn

Bonn, 53105, Germany

Location

Universitätshautklinik Essen

Essen, 45122, Germany

Location

Department of Dermatology, Johann Wolfgang Goethe-University

Frankfurt am Main, 60590, Germany

Location

SRH Wald-Klinikum Gera gGmbH

Gera, 07584, Germany

Location

Clinical Trial Center North

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30449, Germany

Location

Universitätshautklinik Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Diamant Thaci, MD

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2013-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)