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

NCT00717769 | Completed Phase 2 Results

• 1 other identifier: ASBI 404
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; SUN13834

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

SUN13834

EXPERIMENTAL

Drug: SUN13834

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SUN13834 DRUG

Low dose, orally 3 times a day (tid) for 28 days of SUN13834

SUN13834

Placebo DRUG

Placebo, orally (tid) for 28 days of SUN13834

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (28)

Radiant Research, Inc.

Birmingham, Alabama, 35209, United States

Location

Pivotal Research Center

Mesa, Arizona, 85210, United States

Location

Pivotal Research Center

Peoria, Arizona, 85381, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, 32174, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Deaconess Clinic Downtown Research Institute

Evansville, Indiana, 47713, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Academic Dermatology

Albuquerque, New Mexico, 87106, United States

Location

Derm Research Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Wake Forest University Health Sciences - Dermatology Studies

Winston-Salem, North Carolina, 27157, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Oklahoma University Health Sciences Center, Dermatology Dept

Oklahoma City, Oklahoma, 73104, United States

Location

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Radiant Research, Inc

Greer, South Carolina, 29651, United States

Location

J & S Studies, Inc

College Station, Texas, 77845, United States

Location

Baylor Research Institute of Dermatology Department

Dallas, Texas, 75246, United States

Location

Dermatology Associates of San Antonio

San Antonio, Texas, 78258, United States

Location

Intermountain Clinical Research

Draper, Utah, 84020, United States

Location

Commonwealth Clinical Research Specialists, Inc.

Richmond, Virginia, 23233, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

6-(5-chloro-2-methoxybenzyl)-4-alarkylaminocarbonyl-1,4-diazepane-2,5-dione

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: July 16, 2008
• Primary Completion: April 9, 2009
• Study Completion: April 9, 2009
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

US (28)