A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: SUN13834; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research, Inc.
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Pivotal Research Center
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Florida
    • Miami, Florida, United States, 33143
      • Miami Research Associates
    • Ormond Beach, Florida, United States, 32174
      • Advanced Dermatology and Cosmetic Surgery
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Downtown Research Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology
  • New York
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York, Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences - Dermatology Studies
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • Toledo Center for Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Sciences Center, Dermatology Dept
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc.
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Radiant Research, Inc
  • Texas
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute of Dermatology Department
    • San Antonio, Texas, United States, 78258
      • Dermatology Associates of San Antonio
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23233
      • Commonwealth Clinical Research Specialists, Inc.
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo, orally (tid) for 28 days of SUN13834
EXPERIMENTAL: SUN13834	Drug: SUN13834; Low dose, orally 3 times a day (tid) for 28 days of SUN13834

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis	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.	Pre-dose
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	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.	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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	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.	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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	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).	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis	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.	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis	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.	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis	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.	Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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	Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.	Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis	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.	Baseline up to Week 8 post-dose, up to a total of 36 weeks.

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2008
• Primary Completion (ACTUAL): April 9, 2009
• Study Completion (ACTUAL): April 9, 2009

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (ESTIMATE): July 17, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; SUN13834
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ASBI 404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR