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

Phase 2

Terminated

• Conditions: Hidradenitis Suppurativa

• Registration Number: NCT01838499
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Study Start: 2013-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-13
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Results First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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")	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	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Norfolk, Virginia, United States