Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: December 15, 2009
Last updated: March 17, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Pruritus in Patients With Atopic Dermatitis
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI) [ Time Frame: 2 weeks ]
  • Safety and tolerability of DNK333 in atopic dermatitis patients [ Time Frame: 2 weeks ]
  • the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333. [ Time Frame: 2 weeks ]
  • Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score. [ Time Frame: 2 weeks ]
  • Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state. [ Time Frame: 2 weeks ]

Enrollment: 80
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01033097

Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigator Site
Hannover, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Munster, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01033097     History of Changes
Other Study ID Numbers: CDNK333B2103
EudraCT 2009-012098-36 ( Other Identifier: EMEA )
Study First Received: December 15, 2009
Last Updated: March 17, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
inflammatory skin disease

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents processed this record on May 25, 2017