Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
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|ClinicalTrials.gov Identifier: NCT03587805|
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Tralokinumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials|
|Actual Study Start Date :||September 18, 2018|
|Estimated Primary Completion Date :||June 7, 2021|
|Estimated Study Completion Date :||September 13, 2021|
Experimental: Tralokinumab, all subjects
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 140*: SC injection of tralokinumab maintenance dose.
* The length of treatment for each subject will depend on when they enter the trial.
Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
- Number of adverse events from baseline through the last treatment visit (up to Week 142) [ Time Frame: From Week 0 up to Week 142 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587805
|Contact: LEO Pharma A/S||(+1) firstname.lastname@example.org|
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|Study Director:||Medical expert||LEO Pharma|