Clinical trial NCT00717769: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
SUN13834
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Pre-dose
measure: 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
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: 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
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Secondary outcomes:
measure: 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
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: 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
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
measure: Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
measure: Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
measure: Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Baseline up to Week 8 post-dose, up to a total of 36 weeks.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Evansville
country: United States
facility: Deaconess Clinic Downtown Research Institute
state: Indiana
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology
state: New Mexico
city: Stony Brook
country: United States
facility: Derm Research Center of New York, Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences - Dermatology Studies
state: North Carolina
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center, Dermatology Dept
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: College Station
country: United States
facility: J & S Studies, Inc
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute of Dermatology Department
state: Texas
city: San Antonio
country: United States
facility: Dermatology Associates of San Antonio
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Richmond
country: United States
facility: Commonwealth Clinical Research Specialists, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: