Clinical trial NCT01756898: Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
eczema
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 370
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 this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Adult subjects ages 18 to 65 years
* A diagnosis of atopic dermatitis (AD)
* An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
* Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
* Subjects must be practicing acceptable birth control methods

Exclusion Criteria:

* Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
* Use of phototherapy or tanning beds within 6 weeks of screening
* Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
* Female subjects who are pregnant or breastfeeding

Primary outcomes:
measure: Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
timeFrame: Baseline up to 29 days after initial dose.
measure: Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
timeFrame: Baseline up to 29 days after initial dose.
Secondary outcomes:
measure: Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
timeFrame: Baseline up to 29 days after initial dose.
measure: Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
timeFrame: Baseline up to 29 days after initial dose.
measure: Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
timeFrame: Baseline up to 29 days after initial dose.
measure: Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
timeFrame: Baseline up to 29 days after initial dose.
measure: Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
timeFrame: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
measure: Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
timeFrame: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
measure: Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
timeFrame: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
measure: Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
timeFrame: Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
timeFrame: Baseline up to Day 57 follow-up visit post dose.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Rogers
country: United States
state: Arkansas
city: Encino
country: United States
state: California
city: Fremont
country: United States
state: California
city: San Diego
country: United States
state: California
city: Temecula
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Saint Augustine
country: United States
state: Florida
city: South Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Overland Park
country: United States
state: Kansas
city: Crowley
country: United States
state: Louisiana
city: Bay City
country: United States
state: Michigan
city: Clinton Township
country: United States
state: Michigan
city: Fort Gratiot
country: United States
state: Michigan
city: Berlin
country: United States
state: New Jersey
city: Verona
country: United States
state: New Jersey
city: Stony Brook
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Sylvania
country: United States
state: Ohio
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Arlington
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Pflugerville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Draper
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Henrico
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: