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

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


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

Acronym: null
Other IDs: D5440C00001
NCT Number: NCT01838499
Sponsor Collaborators: AstraZeneca|ICON plc|Covance|PHT Corporation
Funding: Industry


HIDRADENITIS SUPPURATIVA CLINICAL TRIAL STATUS

Recruiting Status: Completed
Recruiting Genders: Both
Recruiting Age Groups: Adult
Interventions: Biological: MEDI8968|Biological: Saline
Phases: Phase 2


CLINICAL STUDY DETAILS & RESULTS

STUDY TYPES: Interventional
STUDY DESIGNS: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Results First Received: No Study Results Posted
Study Result (if available): No Results Available
Primary Completion Date: October 2014
Outcome Measures: 1) Proportion of subjects achieving a clinically relevant response in Physician Global Assessment (PGA), with score 0,1 or 2 from baseline to 12 weeks|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”)|3) Change from baseline to 12 weeks in Numerical Assessment Scale (NRS) for pain|4) Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry and urinalysis|5) Quality of life assessment using the Dermatology Life Quality Index (DLQI)|6) Change from baseline to 12 weeks in the average daily pain score|7) Pharmacokinetics (PK) of MEDI8968|8) Percentage of subjects achieving a clinically significant reduction in HS by physician assessment


CLINICAL STUDIES DATES & MILESTONES

First Received: April 19, 2013
Start Date: May 2013
Completion Date: October 2014
Last Updated: November 17, 2014
last Verified: November 2014


Source: https://ClinicalTrials.gov/show/NCT01838499


Public Domain Source: ClinicalTrials.gov query for “Hidradenitis suppurativa” clinical studies (last updated January 2016).


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