Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEDI8968
Saline
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MEDI8968
Saline
Arm Description
Outcomes
Primary Outcome Measures
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
Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12
Secondary Outcome Measures
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")
Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are "minimally improved", "much improved" or "very much improved" on the Patient's Global Impression of Change (PGIC)
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.
Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit.
Full Information
NCT ID
NCT01838499
First Posted
April 19, 2013
Last Updated
July 21, 2016
Sponsor
AstraZeneca
Collaborators
ICON plc, Covance, PHT Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01838499
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
At the planned IA for decision making, no evidence was demonstrated of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
ICON plc, Covance, PHT Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI8968
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MEDI8968
Other Intervention Name(s)
Investigational Product
Intervention Description
SC injection at baseline, Week 4 and Week 8
Intervention Type
Biological
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
SC injection at baseline, Week 4 and Week 8
Primary Outcome Measure Information:
Title
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
Description
Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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")
Description
Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are "minimally improved", "much improved" or "very much improved" on the Patient's Global Impression of Change (PGIC)
Time Frame
12 weeks
Title
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Description
Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.
Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert AK Lee, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Research Site
City
Fremont
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
West Dundee
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Forest Hills
State/Province
New York
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
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