Safety and Efficacy of DNK333 in Atopic Dermatitis Patients - Full Text View

Purpose

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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Eczema Itching Skin Conditions

Drug Information available for: Betamethasone sodium phosphate Betamethasone Betamethasone valerate Betamethasone dipropionate

U.S. FDA Resources

Further study details as provided by Novartis:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of DNK333 in atopic dermatitis patients [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033097

Locations

Germany
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

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01033097 History of Changes
Other Study ID Numbers:	CDNK333B2103, EudraCT 2009-012098-36
Study First Received:	December 15, 2009
Last Updated:	July 25, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Dermatitis
inflammatory skin disease
itch
eczema

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms

Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013