Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
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ClinicalTrials.gov Identifier: NCT01838499 |
Recruitment Status :
Terminated
(At the planned IA for decision making, no evidence was demonstrated of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.)
First Posted : April 24, 2013
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Biological: MEDI8968 Biological: Saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: MEDI8968 |
Biological: MEDI8968
SC injection at baseline, Week 4 and Week 8
Other Name: Investigational Product |
Placebo Comparator: Saline |
Biological: Saline
SC injection at baseline, Week 4 and Week 8
Other Name: Placebo |
- 1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks [ Time Frame: 12 weeks ]Percentage 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
- 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") [ Time Frame: 12 weeks ]Percentage 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)
- Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain [ Time Frame: 12 weeks ]
Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.
Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838499
United States, Arizona | |
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Phoenix, Arizona, United States | |
United States, California | |
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Bakersfield, California, United States | |
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Fremont, California, United States | |
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Los Angeles, California, United States | |
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San Diego, California, United States | |
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San Francisco, California, United States | |
United States, Florida | |
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Miami, Florida, United States | |
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Orange Park, Florida, United States | |
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Ormond Beach, Florida, United States | |
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Tampa, Florida, United States | |
United States, Georgia | |
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Atlanta, Georgia, United States | |
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Macon, Georgia, United States | |
United States, Illinois | |
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Skokie, Illinois, United States | |
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West Dundee, Illinois, United States | |
United States, Indiana | |
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Evansville, Indiana, United States | |
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Indianapolis, Indiana, United States | |
United States, Maryland | |
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Rockville, Maryland, United States | |
United States, Missouri | |
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Saint Louis, Missouri, United States | |
United States, New York | |
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Forest Hills, New York, United States | |
United States, North Carolina | |
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Chapel Hill, North Carolina, United States | |
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High Point, North Carolina, United States | |
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Winston-Salem, North Carolina, United States | |
United States, Pennsylvania | |
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Hershey, Pennsylvania, United States | |
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Philadelphia, Pennsylvania, United States | |
United States, South Dakota | |
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Rapid City, South Dakota, United States | |
United States, Texas | |
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Arlington, Texas, United States | |
United States, Virginia | |
Research Site | |
Norfolk, Virginia, United States |
Principal Investigator: | Robert AK Lee, MD | University of California, San Diego |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01838499 |
Other Study ID Numbers: |
D5440C00001 |
First Posted: | April 24, 2013 Key Record Dates |
Results First Posted: | September 1, 2016 |
Last Update Posted: | September 1, 2016 |
Last Verified: | July 2016 |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |