Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT04587453
- Lead Sponsor
- LEO Pharma
- Brief Summary
Primary objective:
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tralokinumab+TCS Topical corticosteroids (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. Placebo+TCS Placebo 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. Placebo+TCS Topical corticosteroids (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. Tralokinumab+TCS Tralokinumab 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.
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 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).
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 Week 0 to 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.
- Secondary Outcome Measures
Name Time Method Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16 Week 0 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.Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. Week 0 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.
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject Week 0 to Week 16 Number of events divided by patient years of exposure (= rate).
At Least 90% Reduction in EASI (EASI90) at Week 16 Week 0 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.
Percentage Change in EASI Score From Baseline to Week 16 Week 0 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.
Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16 Week 0 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'.
Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16 Week 0 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').
Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 Week 0 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.
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16 Week 0 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'.
At Least 50% Reduction in EASI (EASI50) at Week 16 Week 0 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.
Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16 Week 0 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.
Trial Locations
- Locations (1)
LEO Investigational Site
🇯🇵Fukuoka, Japan