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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
ICON plc
PHT Corporation
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hidradenitis Suppurativa
Interventions: Biological: MEDI8968
Biological: Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
221 subjects enrolled, 109 randomised. Enrolment for ERF based on info databased, as per programmed outputs and the CSR - the criteria being to have provided written consent. 3 additional patients were accounted for in the PRF. M and F subjects with moderate to severe HS were randomised to MEDI8968 or Placebo. 29 centres in the US involved.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomisation to treatment was stratified by PGA score on the day of randomisation (Stratum 1=PGA score of 3; Stratum 2=PGA score of 4 or 5).

Reporting Groups
MEDI8968 SC injection
Saline SC injection

Participant Flow:   Overall Study
    MEDI8968   Saline
STARTED   55   54 
COMPLETED   31   37 
NOT COMPLETED   24   17 
Protocol Violation                0                1 
Lost to Follow-up                2                4 
Lack of Efficacy                1                2 
Adverse Event                2                1 
Withdrawal by Subject                19                9 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups
MEDI8968 SC injection
Saline SC injection
Total Total of all reporting groups

Baseline Measures
   MEDI8968   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   54   109 
[Units: Years]
Mean (Standard Deviation)
 37.5  (11.08)   36.4  (12.42)   36.9  (11.72) 
[Units: Participants]
Female   45   38   83 
Male   10   16   26 

  Outcome Measures

1.  Primary:   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 ]

2.  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")   [ Time Frame: 12 weeks ]

3.  Secondary:   Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial terminated early due to lack of efficacy. An interim analysis was conducted after the first 61 subjects at 12 weeks and showed no evidence of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Humphrey Gardner MD FCAP
Organization: AstraZeneca
phone: +1 781 839 4523

Responsible Party: AstraZeneca Identifier: NCT01838499     History of Changes
Other Study ID Numbers: D5440C00001
First Submitted: April 19, 2013
First Posted: April 24, 2013
Results First Submitted: October 13, 2015
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016