Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa

July 21, 2016 updated by: AstraZeneca

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • 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
    • Florida
      • 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
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Macon, Georgia, United States
        • Research Site
    • Illinois
      • Skokie, Illinois, United States
        • Research Site
      • West Dundee, Illinois, United States
        • Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Maryland
      • Rockville, Maryland, United States
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Research Site
    • New York
      • Forest Hills, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • High Point, North Carolina, United States
        • Research Site
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Texas
      • Arlington, Texas, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Biological: Saline
SC injection at baseline, Week 4 and Week 8
Other Names:
  • Placebo
EXPERIMENTAL: MEDI8968
Biological: MEDI8968
SC injection at baseline, Week 4 and Week 8
Other Names:
  • Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
Time Frame: 12 weeks
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)
12 weeks
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Time Frame: 12 weeks

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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Covance
ICON plc
PHT Corporation

Investigators

  • Principal Investigator: Robert AK Lee, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (ESTIMATE)

April 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5440C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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