Atopic Dermatitis
Conditions
Sponsors
LEO Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or -1346. - Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial). - Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
Exclusion criteria
Exclusion criteria: - Any condition that required permanent discontinuation of trial treatment in the parent trial. - More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline). - Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. - Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. - Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 5 half-lives prior to baseline. - Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline. - Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational biologic agents - Clinically significant infection within 4 weeks prior to baseline. - A helminth parasitic infection within 6 months prior to the date when informed consent is obtained. - Tuberculosis requiring treatment within 12 months prior to screening. - Known primary immunodeficiency disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of adverse events during the treatment period from baseline up to Week 268 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ] The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). - At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial, at Weeks 16, 56, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ] The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. | — |
Countries
Europe, Japan, North America
Outcome results
None listed