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

Study Overview
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Brief Summary
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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

Official Title
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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
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Hidradenitis Suppurativa

Intervention / Treatment
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* Biological: MEDI8968
* Biological: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI8968<br> | Biological: MEDI8968<br>* SC injection at baseline, Week 4 and Week 8<br>* Other names: Investigational Product;|
| Placebo Comparator: Saline<br> | Biological: Saline<br>* SC injection at baseline, Week 4 and Week 8<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 12 weeks | 
| Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | 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. | 12 weeks |