A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
- Registration Number
- NCT00717769
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- Male or female participants between 18 and 65 years of age.
- A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
- At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.
- Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
- Use of phototherapy or tanning beds within 6 weeks of screening
- History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
- Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SUN13834 SUN13834 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pre-dose Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales.
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
- Secondary Outcome Measures
Name Time Method Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose. Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose. Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Baseline up to Week 8 post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Trial Locations
- Locations (27)
Paddington Testing Co, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Dermatology Associates of San Antonio
🇺🇸San Antonio, Texas, United States
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Advanced Dermatology and Cosmetic Surgery
🇺🇸Ormond Beach, Florida, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Deaconess Clinic Downtown Research Institute
🇺🇸Evansville, Indiana, United States
Academic Dermatology
🇺🇸Albuquerque, New Mexico, United States
Michigan Center for Skin Care Research
🇺🇸Clinton Township, Michigan, United States
Derm Research Center of New York, Inc.
🇺🇸Stony Brook, New York, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Radiant Research, Inc
🇺🇸Greer, South Carolina, United States
J & S Studies, Inc
🇺🇸College Station, Texas, United States
Intermountain Clinical Research
🇺🇸Draper, Utah, United States
Commonwealth Clinical Research Specialists, Inc.
🇺🇸Richmond, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Baylor Research Institute of Dermatology Department
🇺🇸Dallas, Texas, United States
Wake Forest University Health Sciences - Dermatology Studies
🇺🇸Winston-Salem, North Carolina, United States
Radiant Research, Inc.
🇺🇸Birmingham, Alabama, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
Oklahoma University Health Sciences Center, Dermatology Dept
🇺🇸Oklahoma City, Oklahoma, United States