Back to resultsSafety and Efficacy of DNK333 in Atopic Dermatitis Patients
Primary Purpose
Pruritus in Patients With Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
DNK333 5 mg
Placebo to 5 mg
DNK333 25 mg
Placebo to 25 mg
DNK333 100 mg
Placebo to 100 mg
Betamethasone 4 mg
DNK333 1mg
Placebo to 1mg
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus in Patients With Atopic Dermatitis focused on measuring Dermatitis, inflammatory skin disease, itch, eczema
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigator Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Active Comparator
Experimental
Placebo Comparator
Arm Label
DNK333 5 mg
Placebo to DNK333 5mg
DNK333 25 mg
Placebo to DNK333 25 mg
DNK333 100 mg
Placebo to DNK333 100 mg
Betamethasone 4 mg
DNK333 1 mg
placebo 1mg
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
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)
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.
Full Information
NCT ID
NCT01033097
First Posted
December 15, 2009
Last Updated
March 17, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01033097
Brief Title
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus in Patients With Atopic Dermatitis
Keywords
Dermatitis, inflammatory skin disease, itch, eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DNK333 5 mg
Arm Type
Experimental
Arm Title
Placebo to DNK333 5mg
Arm Type
Placebo Comparator
Arm Title
DNK333 25 mg
Arm Type
Experimental
Arm Title
Placebo to DNK333 25 mg
Arm Type
Placebo Comparator
Arm Title
DNK333 100 mg
Arm Type
Experimental
Arm Title
Placebo to DNK333 100 mg
Arm Type
Placebo Comparator
Arm Title
Betamethasone 4 mg
Arm Type
Active Comparator
Arm Title
DNK333 1 mg
Arm Type
Experimental
Arm Title
placebo 1mg
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DNK333 5 mg
Intervention Description
5 mg oral
Intervention Type
Drug
Intervention Name(s)
Placebo to 5 mg
Intervention Description
5 mg placebo oral
Intervention Type
Drug
Intervention Name(s)
DNK333 25 mg
Intervention Description
25 mg oral
Intervention Type
Drug
Intervention Name(s)
Placebo to 25 mg
Intervention Description
25 mg placebo oral
Intervention Type
Drug
Intervention Name(s)
DNK333 100 mg
Intervention Description
100 mg oral
Intervention Type
Drug
Intervention Name(s)
Placebo to 100 mg
Intervention Description
100 mg placebo oral
Intervention Type
Drug
Intervention Name(s)
Betamethasone 4 mg
Intervention Description
4 mg oral
Intervention Type
Drug
Intervention Name(s)
DNK333 1mg
Intervention Description
1 mg oral
Intervention Type
Drug
Intervention Name(s)
Placebo to 1mg
Intervention Description
1 mg placebo oral
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
Time Frame
2 weeks
Title
Safety and tolerability of DNK333 in atopic dermatitis patients
Time Frame
2 weeks
Title
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.
Time Frame
2 weeks
Title
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.
Time Frame
2 weeks
Title
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
City
Munster
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
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