Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

Study Overview
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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.

Official Title
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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

Conditions
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Pruritus in Patients With Atopic Dermatitis

Intervention / Treatment
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* Drug: DNK333 5 mg
* Drug: Placebo to 5 mg
* Drug: DNK333 25 mg
* Drug: Placebo to 25 mg
* Drug: DNK333 100 mg
* Drug: Placebo to 100 mg
* Drug: Betamethasone 4 mg
* Drug: DNK333 1mg
* Drug: Placebo to 1mg


Participation Criteria
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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. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DNK333 5 mg<br> | Drug: DNK333 5 mg<br>* 5 mg oral<br>|
| Placebo Comparator: Placebo to DNK333 5mg<br> | Drug: Placebo to 5 mg<br>* 5 mg placebo oral<br>|
| Experimental: DNK333 25 mg<br> | Drug: DNK333 25 mg<br>* 25 mg oral<br>|
| Placebo Comparator: Placebo to DNK333 25 mg<br> | Drug: Placebo to 25 mg<br>* 25 mg placebo oral<br>|
| Experimental: DNK333 100 mg<br> | Drug: DNK333 100 mg<br>* 100 mg oral<br>|
| Placebo Comparator: Placebo to DNK333 100 mg<br> | Drug: Placebo to 100 mg<br>* 100 mg placebo oral<br>|
| Active Comparator: Betamethasone 4 mg<br> | Drug: Betamethasone 4 mg<br>* 4 mg oral<br>|
| Experimental: DNK333 1 mg<br> | Drug: DNK333 1mg<br>* 1 mg oral<br>|
| Placebo Comparator: placebo 1mg<br> | Drug: Placebo to 1mg<br>* 1 mg placebo oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, inflammatory skin disease, itch, eczema