NCT01838499TerminatedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 224
- Locations
- 27
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline
Placebo Comparator
Intervention: Saline (Biological)
MEDI8968
Experimental
Intervention: MEDI8968 (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain(12 weeks)
Investigators
Study Sites (27)
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