Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
- Registration Number
- NCT03587805
- Lead Sponsor
- LEO Pharma
- Brief Summary
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1672
Inclusion Criteria
- Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
- Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- 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
- 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 corticosteroid within 4 weeks prior to baseline.
- Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tralokinumab, all subjects Tralokinumab Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
- Primary Outcome Measures
Name Time Method Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) From Week 0 up to Week 268
- Secondary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 From Week 16 up to Week 248 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, 88, 104, 136, 152, 184, 216, and 248 From Week 16 up to Week 248 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.
Trial Locations
- Locations (3)
LEO Pharma Investigational Site 1
🇯🇵Osaka, Japan
LEO Pharma Investigational Site 2
🇯🇵Osaka, Japan
LEO Pharma Investigational Site
🇬🇧Walsall, United Kingdom