Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01033097 | Safety and Efficacy of DNK333 in Atopic Dermatitis Patients | PHASE2 | COMPLETED | 80 | — | — | Nov 1, 2009 | Jul 1, 2011 | Mar 21, 2017 | 5 | Germany |
| Arm | Type | Description |
|---|---|---|
| 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 | EXPERIMENTAL | - |
| placebo 1mg | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DNK333 5 mg | DRUG | 5 mg oral |
| Placebo to 5 mg | 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 |
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 ...