Clinical trial NCT01033097: Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
Official title: A Multicenter, Randomized, Double-blinded, Placebo and Positive Controlled Study to Evaluate the Anti-pruritic Effect, Safety and Tolerability, Systemic and Skin Exposure, After 2 Weeks of Treatment With a Microemulsion Formulation of DNK333 in Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus in Patients With Atopic Dermatitis
Keywords: Dermatitis
inflammatory skin disease
itch
eczema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.


Eligibility criteria: Inclusion Criteria:

* Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
* Requirement of systemic therapy
* Itch VAS score higher than 50 mm
* EASI score higher than 8

Exclusion Criteria:

* Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
* Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
* Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)
timeFrame: 2 weeks
measure: Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
timeFrame: 2 weeks
measure: Safety and tolerability of DNK333 in atopic dermatitis patients
timeFrame: 2 weeks
measure: the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.
timeFrame: 2 weeks
measure: Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.
timeFrame: 2 weeks
measure: Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigator Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Munster
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: