Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis

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 106 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

  Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

  Drug: Tralokinumab · Other: Topical corticosteroids (TCS)

• Placebo comparator
  Placebo+TCS

  Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

  Drug: Placebo · Other: Topical corticosteroids (TCS)

Interventions

• DrugTralokinumab

  Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.

• DrugPlacebo

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

• OtherTopical corticosteroids (TCS)

  TCS administered as needed.

Primary outcomes

1. 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 participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

   Time frame: Week 16

2. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

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

   Time frame: Week 0 to Week 16

Secondary outcomes

1. Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16

   SCORAD is a validated tool to evaluate the AD disease based on 3 components: * A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%). * B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18). * C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20). The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease.

   Time frame: Week 0 to Week 16

2. Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.

   DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past 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 (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life.

   Time frame: Week 0 to Week 16

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

   Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

   Time frame: Week 0 to Week 16

4. At Least 90% Reduction in EASI (EASI90) at Week 16

   EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

   Time frame: Week 0 to Week 16

5. At Least 50% Reduction in EASI (EASI50) at Week 16

   EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

   Time frame: Week 0 to Week 16

6. Percentage Change in EASI Score From Baseline to Week 16

   EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

   Time frame: Week 0 to Week 16

7. Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16

   Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

   Time frame: Week 0 to Week 16

8. Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16

   Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered').

   Time frame: Week 0 to Week 16

9. Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16

   POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease.

   Time frame: Week 0 to Week 16

10. Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject

    Number of events divided by patient years of exposure (= rate).

    Time frame: Week 0 to Week 16

11. Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16

    Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative.

    Time frame: Week 0 to Week 16

Baseline characteristics

6 further baseline measures are reported on the registry.

Study documents

• Study protocol · Jul 20, 2020
• Statistical analysis plan · Jun 15, 2021

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

Individual participant data

Plan to share: No