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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
Sponsor:
Collaborators:
ICON plc
Covance
PHT Corporation
Information provided by (Responsible Party):
AstraZeneca

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
Enrollment 224

Recruitment Details 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 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).
Arm/Group Title MEDI8968 Saline
Hide Arm/Group Description SC injection SC injection
Period Title: Overall Study
Started 55 54
Completed 31 37
Not Completed 24 17
Reason Not Completed
Protocol Violation             0             1
Lost to Follow-up             2             4
Lack of Efficacy             1             2
Adverse Event             2             1
Withdrawal by Subject             19             9
Arm/Group Title MEDI8968 Saline Total
Hide Arm/Group Description SC injection SC injection Total of all reporting groups
Overall Number of Baseline Participants 55 54 109
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 54 participants 109 participants
37.5  (11.08) 36.4  (12.42) 36.9  (11.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
Female
45
  81.8%
38
  70.4%
83
  76.1%
Male
10
  18.2%
16
  29.6%
26
  23.9%
1.Primary Outcome
Title 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
Hide Description 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
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title MEDI8968 Saline
Hide Arm/Group Description:
SC injection
SC injection
Overall Number of Participants Analyzed 55 54
Measure Type: Number
Unit of Measure: % of patients
Responders (%) 23.6 18.5
Non-responders (%) 76.4 81.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEDI8968, Saline
Comments Analysis of proportion of Responders for Physician’s Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.051
Confidence Interval (2-Sided) 80%
-0.067 to 0.169
Estimation Comments MEDI8968 - placebo
2.Secondary Outcome
Title 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")
Hide Description 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)
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MEDI8968 Saline
Hide Arm/Group Description:
SC injection
SC injection
Overall Number of Participants Analyzed 55 54
Measure Type: Number
Unit of Measure: % of patients
Responders (%) 49.1 55.6
Non-Responders (%) 50.9 44.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEDI8968, Saline
Comments Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.065
Confidence Interval (2-Sided) 80%
-0.205 to 0.076
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Hide Description

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.

Time Frame 12 weeks
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Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title MEDI8968 Saline
Hide Arm/Group Description:
SC injection
SC injection
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: changes in scores on a scale
Week 4 -1.09  (0.35) -1.02  (0.36)
Week 8 -1.76  (0.36) -1.31  (0.36)
Week 12 -1.79  (0.46) -1.76  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEDI8968, Saline
Comments Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.945
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Change from baseline (at week 12)
Estimated Value -0.03
Confidence Interval (2-Sided) 80%
-0.63 to 0.57
Estimation Comments MEDI8968 - Placebo
Time Frame 24 weeks. However, if a subject withdraws from treatment for any reason prior to week 24, the subject should continue to be seen up to 16 weeks after his/her last dose.
Adverse Event Reporting Description In the tables below all the SAEs are presented. In the Other Adverse events tables please note that a Frequency Threshold of 5% has been applies to reporting the AEs and associated summaries. If, within a treatment group the frequency >= 5%, the associated information has been presented for both treatment arms.
 
Arm/Group Title MEDI8968 Saline
Hide Arm/Group Description SC injection SC injection
All-Cause Mortality
MEDI8968 Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MEDI8968 Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/55 (3.64%)      2/54 (3.70%)    
Blood and lymphatic system disorders     
Anaemia  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Gastrointestinal disorders     
Colitis  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Diverticulum  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Hepatobiliary disorders     
Cholelithiasis  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Infections and infestations     
Bacteraemia  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Bacterial infection  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Cellulitis  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Influenza  1  1/55 (1.82%)  1 0/54 (0.00%)  0
Staphylococcal infection  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Urinary tract infection  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Pheumonia  1  2/55 (3.64%)  2 0/54 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Hypomagnesemia  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/55 (0.00%)  0 1/54 (1.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEDI8968 Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/55 (14.55%)      2/54 (3.70%)    
Gastrointestinal disorders     
Diarrhoea  1  3/55 (5.45%)  3 2/54 (3.70%)  2
General disorders     
Fatigue  1  3/55 (5.45%)  3 0/54 (0.00%)  0
Infections and infestations     
Pheumonia  1  3/55 (5.45%)  3 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
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
ClinicalTrials.gov 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