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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

Tracking Information
First Submitted Date  ICMJE April 19, 2013
First Posted Date  ICMJE April 24, 2013
Results First Submitted Date  ICMJE October 13, 2015
Results First Posted Date  ICMJE September 1, 2016
Last Update Posted Date September 1, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
1) Proportion 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 ]
Proportion 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
Change History Complete list of historical versions of study NCT01838499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
  • 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 ]
    Proportion of subjects achieving a clinically significant repsonse measured by the propotion of subjects who are "minimally improved", "much improved" or "very much improved" on the Patient's Global Impression of Change (PGIC)
  • 3) Change from baseline to 12 weeks in Numerical Assessment Scale (NRS) for pain [ Time Frame: 12 weeks ]
    Assessment of change in pain via NRS
  • 4) Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry and urinalysis [ Time Frame: 24 weeks ]
    AEs, vital signs, laboratory assessments, ECG
  • 5) Quality of life assessment using the Dermatology Life Quality Index (DLQI) [ Time Frame: 12 weeks ]
    Assessment of health related QoL via DLQI
  • 6) Change from baseline to 12 weeks in the average daily pain score [ Time Frame: 12 weeks ]
    Assessment of the proportion of patients achieving a reduction in average daily pain
  • 7) Pharmacokinetics (PK) of MEDI8968 [ Time Frame: 24 weeks ]
    Concentration of and exposure to MEDI8968 and development of anti-drug antibodies
  • 8) Percentage of subjects achieving a clinically significant reduction in HS by physician assessment [ Time Frame: 12 weeks ]
    Assessment of subjects achieving a clinically significant PGA response as measured by the proportion of subjects achieving at least a 2 step change in PGA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Biological: MEDI8968
    SC injection at baseline, Week 4 and Week 8
    Other Name: Investigational Product
  • Biological: Saline
    SC injection at baseline, Week 4 and Week 8
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: MEDI8968
    Intervention: Biological: MEDI8968
  • Placebo Comparator: Saline
    Intervention: Biological: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
224
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2013)
100
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01838499
Other Study ID Numbers  ICMJE D5440C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE
  • ICON plc
  • Covance
  • PHT Corporation
Investigators  ICMJE
Principal Investigator: Robert AK Lee, MD University of California, San Diego
PRS Account AstraZeneca
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP