Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

• ClinicalTrials.gov Identifier: NCT03587805
• Recruitment Status: Enrolling by invitation
• First Posted: July 16, 2018
• Last Update Posted: May 6, 2021
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Tracking Information

• First Submitted Date: July 3, 2018
• First Posted Date: July 16, 2018
• Last Update Posted Date: May 6, 2021
• Actual Study Start Date: September 18, 2018
• Estimated Primary Completion Date: June 14, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2020): Number of adverse events from baseline through the last treatment visit (up to Week 268) [ Time Frame: From Week 0 up to Week 268 ]
• Original Primary Outcome Measures (submitted: July 3, 2018): Number of adverse events from baseline through the last treatment visit (up to Week 142) [ Time Frame: From Week 0 up to Week 142 ]

Current Secondary Outcome Measures (submitted: December 18, 2020)

• 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: July 3, 2018)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
• 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
• Brief Summary: The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

Drug: Tralokinumab

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.

Study Arms

Experimental: Tralokinumab, all subjects

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.

Intervention: Drug: Tralokinumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: December 18, 2020): 1600
• Original Estimated Enrollment (submitted: July 3, 2018): 1125
• Estimated Study Completion Date: June 28, 2024
• Estimated Primary Completion Date: June 14, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Czechia, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03587805
• Other Study ID Numbers: LP0162-1337
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• URL: http://leopharmatrials.com/for-professionals

• Responsible Party: LEO Pharma
• Study Sponsor: LEO Pharma
• Collaborators: Not Provided

Investigators

• Study Director: Medical expert; LEO Pharma

• PRS Account: LEO Pharma
• Verification Date: May 2021