Clinical trial NCT01838499: Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase IIa Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
name: Covance
name: PHT Corporation
First posted: 2013-04-24
Enrollment: 224
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 study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa


Eligibility criteria: Inclusion Criteria:

* Hidradenitis suppurativa (HS) (moderate to severe)
* Diagnosis of HS for at least 1 year
* At least 5 active inflammatory lesions in at least 2 locations
* On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already taking these medications)
* Average pain score of 3-9.

Exclusion Criteria:

* History of cyclic neutropenia
* Laboratory assessment abnormalities
* Underlying disorder considered unsuitable for inclusion
* Other skin diseases that may interfere with HS assessment
* Pregnancy or planning for pregnancy

Primary outcomes:
measure: 1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: 2) Subject's Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 "Very Much Improved" to 7 "Very Much Worse")
timeFrame: 12 weeks
measure: Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Fremont
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orange Park
country: United States
facility: Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: West Dundee
country: United States
facility: Research Site
state: Illinois
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Forest Hills
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: University of California, San Diego
name: Robert AK Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: