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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ICON plc
Covance
PHT Corporation
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01838499
First received: April 19, 2013
Last updated: September 30, 2014
Last verified: September 2014
  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) 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 ] [ Designated as safety issue: No ]
    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


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 ]
    Proportion 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)

  • 3) Change from baseline to 12 weeks in Numerical Assessment Scale (NRS) for pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    AEs, vital signs, laboratory assessments, ECG

  • 5) Quality of life assessment using the Dermatology Life Quality Index (DLQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of health related QoL via DLQI

  • 6) Change from baseline to 12 weeks in the average daily pain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of the proportion of patients achieving a reduction in average daily pain

  • 7) Pharmacokinetics (PK) of MEDI8968 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated 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
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01838499     History of Changes
Other Study ID Numbers: D5440C00001
Study First Received: April 19, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014