Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

Browse trials for

• Dermatitis, Atopic 1,419
• Dermatitis 1,435
• Eczema 1,084

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 277 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Tralokinumab + TCS

  4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

  Drug: Tralokinumab

• Placebo comparator
  Placebo + TCS

  4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

  Other: Placebo

Interventions

• DrugTralokinumab

  Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.

• OtherPlacebo

  Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Primary outcomes

1. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16

   EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

   Time frame: Week 0 to Week 16

Secondary outcomes

1. Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16

   Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

   Time frame: Week 0 to Week 16

2. Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16

   SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

   Time frame: Week 0 to Week 16

3. Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16

   DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

   Time frame: Week 0 to Week 16

4. Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

   IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

   Time frame: Week 16

5. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26

   EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

   Time frame: Week 0 to Week 26

6. Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26

   Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

   Time frame: Week 0 to Week 26

7. Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26

   SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

   Time frame: Week 0 to Week 26

8. Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26

   DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

   Time frame: Week 0 to Week 26

9. Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26

   IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

   Time frame: Week 26

10. Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40

    Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.

    Time frame: Week 0 to Week 40

11. Number of Adverse Events From Week 0 to Week 40

    All adverse events are presented below under Adverse Events

    Time frame: Week 0 to Week 40

Baseline characteristics

6 further baseline measures are reported on the registry.

Study documents

• Study protocol · Jun 15, 2020
• Statistical analysis plan · Oct 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No