Status:

TERMINATED

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

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

ICON plc

Covance

Conditions:

Hidradenitis Suppurativa

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2014

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT01838499

Start Date

May 1 2013

End Date

October 1 2014

Last Update

September 1 2016

Active Locations (27)

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Page 1 of 7 (27 locations)

1

Research Site

Phoenix, Arizona, United States

2

Research Site

Bakersfield, California, United States

3

Research Site

Fremont, California, United States

4

Research Site

Los Angeles, California, United States