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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01447758
First received: July 13, 2011
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: LEO 29102
Drug: LEO 29102 Cream Vehicle
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • PK profile - Cohort I, II, III [ 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) ] [ Designated as safety issue: No ]
    Cmax, AUC, Tmax

  • Tolerability and safety of LEO 29102 cream - Cohort I, II, III [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    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

  • PK profile - Cohort IV [ 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 ] [ Designated as safety issue: No ]
    Cmax, AUC, Tmax

  • Tolerability and safety of LEO 29102 cream - Cohort IV [ Time Frame: 49 Days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447758

Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
Bonn, Germany, 53105
Universitätshautklinik Essen
Essen, Germany, 45122
Department of Dermatology, Johann Wolfgang Goethe-University
Frankfurt/Main, Germany, 60590
SRH Wald-Klinikum Gera gGmbH
Gera, Germany, 07584
Clinical Trial Center North
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30449
Universitätshautklinik Münster
Münster, Germany, 48149
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Diamant Thaci, MD Goethe University
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01447758     History of Changes
Other Study ID Numbers: LEO 29102-C26
Study First Received: July 13, 2011
Last Updated: April 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014