A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
NCT ID: NCT00717769
Last Updated: 2021-04-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2008-07-16
2009-04-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis
NCT00703573
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
NCT01756898
A Trial of Antroquinonol in Patients With Atopic Dermatitis
NCT03622463
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169
Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT02277743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SUN13834
SUN13834
Low dose, orally 3 times a day (tid) for 28 days of SUN13834
Placebo
Placebo
Placebo, orally (tid) for 28 days of SUN13834
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SUN13834
Low dose, orally 3 times a day (tid) for 28 days of SUN13834
Placebo
Placebo, orally (tid) for 28 days of SUN13834
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research, Inc.
Birmingham, Alabama, United States
Pivotal Research Center
Mesa, Arizona, United States
Pivotal Research Center
Peoria, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Therapeutics Clinical Research
San Diego, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Miami Research Associates
Miami, Florida, United States
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
Deaconess Clinic Downtown Research Institute
Evansville, Indiana, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Academic Dermatology
Albuquerque, New Mexico, United States
Derm Research Center of New York, Inc.
Stony Brook, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Wake Forest University Health Sciences - Dermatology Studies
Winston-Salem, North Carolina, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Oklahoma University Health Sciences Center, Dermatology Dept
Oklahoma City, Oklahoma, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 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
Baylor Research Institute of Dermatology Department
Dallas, Texas, United States
Dermatology Associates of San Antonio
San Antonio, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASBI 404
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.