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

This study has been terminated.
(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.)
Sponsor:
Collaborators:
ICON plc
Covance
PHT Corporation
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01838499
First received: April 19, 2013
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
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

Condition Intervention Phase
Hidradenitis Suppurativa
Biological: MEDI8968
Biological: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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") [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 224
Study Start Date: May 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI8968 Biological: MEDI8968
SC injection at baseline, Week 4 and Week 8
Other Name: Investigational Product
Placebo Comparator: Saline Biological: Saline
SC injection at baseline, Week 4 and Week 8
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838499

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
ICON plc
Covance
PHT Corporation
Investigators
Principal Investigator: Robert AK Lee, MD University of California, San Diego
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01838499     History of Changes
Other Study ID Numbers: D5440C00001 
Study First Received: April 19, 2013
Results First Received: October 13, 2015
Last Updated: July 21, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration

ClinicalTrials.gov processed this record on September 23, 2016