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

AstraZeneca logo

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

224 participants in 2 patient groups, including a placebo group

MEDI8968
Experimental group
Treatment:
Biological: MEDI8968
Saline
Placebo Comparator group
Treatment:
Biological: Saline

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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