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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2009-012098-36 | Other Identifier | EMEA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNK333 5 mg | Experimental |
| |
| Placebo to DNK333 5mg | Placebo Comparator |
| |
| DNK333 25 mg | Experimental |
| |
| Placebo to DNK333 25 mg | Placebo Comparator |
| |
| DNK333 100 mg | Experimental |
| |
| Placebo to DNK333 100 mg | Placebo Comparator |
| |
| Betamethasone 4 mg | Active Comparator |
| |
| DNK333 1 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNK333 5 mg | Drug | 5 mg oral |
| |
| Placebo to 5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP) | 2 weeks | |
| Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | Germany | ||||
| Novartis Investigative Site |
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|
| placebo 1mg | Placebo Comparator |
|
| Drug |
5 mg placebo oral |
|
| DNK333 25 mg | Drug | 25 mg oral |
|
| Placebo to 25 mg | Drug | 25 mg placebo oral |
|
| DNK333 100 mg | Drug | 100 mg oral |
|
| Placebo to 100 mg | Drug | 100 mg placebo oral |
|
| Betamethasone 4 mg | Drug | 4 mg oral |
|
| DNK333 1mg | Drug | 1 mg oral |
|
| Placebo to 1mg | Drug | 1 mg placebo oral |
|
| 2 weeks |
| Safety and tolerability of DNK333 in atopic dermatitis patients | 2 weeks |
| the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333. | 2 weeks |
| Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score. | 2 weeks |
| Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state. | 2 weeks |
| Frankfurt |
| Germany |
| Novartis Investigator Site | Hanover | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Münster | Germany |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D011537 | Pruritus |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| C448383 | DNK 333 |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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