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

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.

Study Overview

• Status: Completed
• Conditions: Pruritus in Patients With Atopic Dermatitis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Novartis Investigative Site
  • Frankfurt, Germany
    • Novartis Investigative Site
  • Hannover, Germany
    • Novartis Investigator Site
  • Kiel, Germany
    • Novartis Investigative Site
  • Munster, Germany
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DNK333 5 mg	Drug: DNK333 5 mg; 5 mg oral
PLACEBO_COMPARATOR: Placebo to DNK333 5mg	Drug: Placebo to 5 mg; 5 mg placebo oral
EXPERIMENTAL: DNK333 25 mg	Drug: DNK333 25 mg; 25 mg oral
PLACEBO_COMPARATOR: Placebo to DNK333 25 mg	Drug: Placebo to 25 mg; 25 mg placebo oral
EXPERIMENTAL: DNK333 100 mg	Drug: DNK333 100 mg; 100 mg oral
PLACEBO_COMPARATOR: Placebo to DNK333 100 mg	Drug: Placebo to 100 mg; 100 mg placebo oral
ACTIVE_COMPARATOR: Betamethasone 4 mg	Drug: Betamethasone 4 mg; 4 mg oral
EXPERIMENTAL: DNK333 1 mg	Drug: DNK333 1mg; 1 mg oral
PLACEBO_COMPARATOR: placebo 1mg	Drug: Placebo to 1mg; 1 mg placebo oral

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (ESTIMATE): December 16, 2009

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: eczema; Dermatitis; itch; inflammatory skin disease
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: CDNK333B2103; EudraCT 2009-012098-36 (OTHER: EMEA)