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

Phase 2TerminatedNCT01838499

AstraZeneca224 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

224

Conditions

Hidradenitis Suppurativa

Interventions

MEDI8968BIOLOGICAL

SC injection at baseline, Week 4 and Week 8

SalineBIOLOGICAL

SC injection at baseline, Week 4 and Week 8

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (27)

Research Site

Phoenix, Arizona, United States

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

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

Time frame: 12 weeks

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")

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)

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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