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Completed

NCT Number: NCT01033097

Safety and Efficacy 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.

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Key information

Conditions

Pruritus in Patients With Atopic Dermatitis Dermatitis Eczema Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNK333 5 mg

Drug

5 mg oral

Placebo to 5 mg

Drug

5 mg placebo oral

DNK333 25 mg

Drug

25 mg oral

Placebo to 25 mg

Drug

25 mg placebo oral

DNK333 100 mg

Drug

100 mg oral

Placebo to 100 mg

Drug

100 mg placebo oral

Betamethasone 4 mg

Drug

4 mg oral

DNK333 1mg

Drug

1 mg oral

Placebo to 1mg

Drug

1 mg placebo oral

Primary outcomes

  1. Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)

    Time frame: 2 weeks

Secondary outcomes

  1. Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)

    Time frame: 2 weeks

  2. Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)

    Time frame: 2 weeks

  3. Safety and tolerability of DNK333 in atopic dermatitis patients

    Time frame: 2 weeks

  4. the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.

    Time frame: 2 weeks

  5. Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.

    Time frame: 2 weeks

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2009
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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