Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01033097

Enrollment

Registered

2009-12-16

Start date

2009-11-30

Completion date

2011-07-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus in Patients With Atopic Dermatitis

Keywords

Dermatitis, inflammatory skin disease, itch, eczema

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.

Interventions

DRUGDNK333 5 mg

5 mg oral

DRUGPlacebo to 5 mg

5 mg placebo oral

DRUGDNK333 25 mg

25 mg oral

DRUGPlacebo to 25 mg

25 mg placebo oral

DRUGDNK333 100 mg

100 mg oral

DRUGPlacebo to 100 mg

100 mg placebo oral

DRUGBetamethasone 4 mg

4 mg oral

DRUGDNK333 1mg

1 mg oral

DRUGPlacebo to 1mg

1 mg placebo oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)	2 weeks

Secondary

Measure	Time frame
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)	2 weeks
Safety and tolerability of DNK333 in atopic dermatitis patients	2 weeks
Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)	2 weeks
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.	2 weeks
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.	2 weeks
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.	2 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026