Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pruritus in Patients With Atopic Dermatitis
Intervention: 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 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
Secondary outcome: Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI) Safety and tolerability of DNK333 in atopic dermatitis patients the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333. Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score. Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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
Additional Information
Starting date: November 2009
Last updated: July 25, 2012
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