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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

Page last updated: August 23, 2015

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