Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pruritus in Patients With Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DNK333 5 mg

Group Type EXPERIMENTAL

DNK333 5 mg

Intervention Type DRUG

5 mg oral

Placebo to DNK333 5mg

Group Type PLACEBO_COMPARATOR

Placebo to 5 mg

Intervention Type DRUG

5 mg placebo oral

DNK333 25 mg

Group Type EXPERIMENTAL

DNK333 25 mg

Intervention Type DRUG

25 mg oral

Placebo to DNK333 25 mg

Group Type PLACEBO_COMPARATOR

Placebo to 25 mg

Intervention Type DRUG

25 mg placebo oral

DNK333 100 mg

Group Type EXPERIMENTAL

DNK333 100 mg

Intervention Type DRUG

100 mg oral

Placebo to DNK333 100 mg

Group Type PLACEBO_COMPARATOR

Placebo to 100 mg

Intervention Type DRUG

100 mg placebo oral

Betamethasone 4 mg

Group Type ACTIVE_COMPARATOR

Betamethasone 4 mg

Intervention Type DRUG

4 mg oral

DNK333 1 mg

Group Type EXPERIMENTAL

DNK333 1mg

Intervention Type DRUG

1 mg oral

placebo 1mg

Group Type PLACEBO_COMPARATOR

Placebo to 1mg

Intervention Type DRUG

1 mg placebo oral

Interventions

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DNK333 5 mg

5 mg oral

Intervention Type DRUG

Placebo to 5 mg

5 mg placebo oral

Intervention Type DRUG

DNK333 25 mg

25 mg oral

Intervention Type DRUG

Placebo to 25 mg

25 mg placebo oral

Intervention Type DRUG

DNK333 100 mg

100 mg oral

Intervention Type DRUG

Placebo to 100 mg

100 mg placebo oral

Intervention Type DRUG

Betamethasone 4 mg

4 mg oral

Intervention Type DRUG

DNK333 1mg

1 mg oral

Intervention Type DRUG

Placebo to 1mg

1 mg placebo oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No