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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Biological: Saline; Biological: MEDI8968

Study type: Interventional

Funder types: Industry

Identifiers

NCT01838499

D5440C00001

Details and patient eligibility

About

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

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

MEDI8968

Experimental group

Treatment:

Biological: MEDI8968

Saline

Placebo Comparator group

Treatment:

Biological: Saline