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

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ClinicalTrials.gov Identifier: NCT01838499
Recruitment Status : 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.)
First Posted : April 24, 2013
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Collaborators:
ICON plc
Covance
PHT Corporation
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: MEDI8968 Biological: Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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)

  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838499


  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
ICON plc
Covance
PHT Corporation
Investigators
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Principal Investigator: Robert AK Lee, MD University of California, San Diego
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01838499     History of Changes
Other Study ID Numbers: D5440C00001
First Posted: April 24, 2013    Key Record Dates
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration