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

Hidradenitis Suppurativa Clinical Trial

Official title:

A Phase IIa Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838499
• Other study ID #: D5440C00001
• 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

• Hidradenitis
• Hidradenitis Suppurativa

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