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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01838499
Other study ID # D5440C00001
Secondary ID
Status Completed
Phase Phase 2
First received April 19, 2013
Last updated November 17, 2014
Start date May 2013
Est. completion date October 2014

Study information

Verified date November 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
MEDI8968
SC injection at baseline, Week 4 and Week 8
Saline
SC injection at baseline, Week 4 and Week 8

Locations

Country Name City State
United States Research Site Arlington Texas
United States Research Site Atlanta Georgia
United States Research Site Bakersfield California
United States Research Site Chapel Hill North Carolina
United States Research Site Evansville Indiana
United States Research Site Forest Hills New York
United States Research Site Fremont California
United States Research Site Hershey Pennsylvania
United States Research Site High Point North Carolina
United States Research Site Indianapolis Indiana
United States Research Site Los Angeles California
United States Research Site Macon Georgia
United States Research Site Miami Florida
United States Research Site Norfolk Virginia
United States Research Site Orange Park Florida
United States Research Site Ormond Beach Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site Phoenix Arizona
United States Research Site Rapid City South Dakota
United States Research Site Rockville Maryland
United States Research Site Saint Louis Missouri
United States Research Site San Diego California
United States Research Site San Francisco California
United States Research Site Skokie Illinois
United States Research Site Tampa Florida
United States Research Site West Dundee Illinois
United States Research Site Winston-Salem North Carolina

Sponsors (4)

Lead Sponsor Collaborator
AstraZeneca Covance, ICON plc, PHT Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion 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 No
Secondary 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") Proportion 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 No
Secondary 3) Change from baseline to 12 weeks in Numerical Assessment Scale (NRS) for pain Assessment of change in pain via NRS 12 weeks No
Secondary 4) Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry and urinalysis AEs, vital signs, laboratory assessments, ECG 24 weeks Yes
Secondary 5) Quality of life assessment using the Dermatology Life Quality Index (DLQI) Assessment of health related QoL via DLQI 12 weeks No
Secondary 6) Change from baseline to 12 weeks in the average daily pain score Assessment of the proportion of patients achieving a reduction in average daily pain 12 weeks No
Secondary 7) Pharmacokinetics (PK) of MEDI8968 Concentration of and exposure to MEDI8968 and development of anti-drug antibodies 24 weeks No
Secondary 8) Percentage of subjects achieving a clinically significant reduction in HS by physician assessment Assessment of subjects achieving a clinically significant PGA response as measured by the proportion of subjects achieving at least a 2 step change in PGA 12 weeks No
See also
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