Study 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.
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
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
1 other identifier
interventional
224
1 country
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
September 1, 2016
CompletedSeptember 1, 2016
July 1, 2016
1.4 years
April 19, 2013
October 13, 2015
July 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Secondary Outcomes (2)
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")
12 weeks
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
12 weeks
Study Arms (2)
MEDI8968
EXPERIMENTALSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of cyclic neutropenia
- Laboratory assessment abnormalities
- Other skin diseases that may interfere with HS assessment
- Pregnancy or planning for pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- ICON plccollaborator
- Covancecollaborator
- PHT Corporationcollaborator
Study Sites (27)
Research Site
Phoenix, Arizona, United States
Research Site
Bakersfield, California, United States
Research Site
Fremont, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Miami, Florida, United States
Research Site
Orange Park, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Macon, Georgia, United States
Research Site
Skokie, Illinois, United States
Research Site
West Dundee, Illinois, United States
Research Site
Evansville, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Rockville, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Forest Hills, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
High Point, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Arlington, Texas, United States
Research Site
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial terminated early due to lack of efficacy. An interim analysis was conducted after the first 61 subjects at 12 weeks and showed no evidence of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.
Results Point of Contact
- Title
- Humphrey Gardner MD FCAP
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Robert AK Lee, MD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2013
First Posted
April 24, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 1, 2016
Results First Posted
September 1, 2016
Record last verified: 2016-07