Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

Phase 2

Completed

• Conditions: Pruritus in Patients With Atopic Dermatitis
• Interventions: 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

• Registration Number: NCT01033097
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DNK333 5 mg	DNK333 5 mg	-
Placebo to DNK333 5mg	Placebo to 5 mg	-
DNK333 25 mg	DNK333 25 mg	-
Placebo to DNK333 25 mg	Placebo to 25 mg	-
DNK333 100 mg	DNK333 100 mg	-
Placebo to DNK333 100 mg	Placebo to 100 mg	-
Betamethasone 4 mg	Betamethasone 4 mg	-
DNK333 1 mg	DNK333 1mg	-
placebo 1mg	Placebo to 1mg	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.	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
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

Trial Locations

Locations (2)

Novartis Investigative Site; 🇩🇪 Munster, Germany

Novartis Investigator Site; 🇩🇪 Hannover, Germany