Trial Outcomes & Findings for Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa (NCT NCT01838499)
NCT ID: NCT01838499
Last Updated: 2016-09-01
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-09-01
Participant Flow
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.
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).
Participant milestones
| Measure |
MEDI8968
SC injection
|
Saline
SC injection
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
31
|
37
|
|
Overall Study
NOT COMPLETED
|
24
|
17
|
Reasons for withdrawal
| Measure |
MEDI8968
SC injection
|
Saline
SC injection
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
19
|
9
|
Baseline Characteristics
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
MEDI8968
n=55 Participants
SC injection
|
Saline
n=54 Participants
SC injection
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 11.08 • n=99 Participants
|
36.4 Years
STANDARD_DEVIATION 12.42 • n=107 Participants
|
36.9 Years
STANDARD_DEVIATION 11.72 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: FAS
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
Outcome measures
| Measure |
MEDI8968
n=55 Participants
SC injection
|
Saline
n=54 Participants
SC injection
|
|---|---|---|
|
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
Non-responders (%)
|
76.4 % of patients
|
81.5 % of patients
|
|
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
Responders (%)
|
23.6 % of patients
|
18.5 % of patients
|
SECONDARY outcome
Timeframe: 12 weeksPercentage 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)
Outcome measures
| Measure |
MEDI8968
n=55 Participants
SC injection
|
Saline
n=54 Participants
SC injection
|
|---|---|---|
|
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")
Responders (%)
|
49.1 % of patients
|
55.6 % of patients
|
|
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")
Non-Responders (%)
|
50.9 % of patients
|
44.4 % of patients
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS (LOCF)
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.
Outcome measures
| Measure |
MEDI8968
n=50 Participants
SC injection
|
Saline
n=50 Participants
SC injection
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Week 4
|
-1.09 changes in scores on a scale
Standard Error 0.35
|
-1.02 changes in scores on a scale
Standard Error 0.36
|
|
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Week 8
|
-1.76 changes in scores on a scale
Standard Error 0.36
|
-1.31 changes in scores on a scale
Standard Error 0.36
|
|
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Week 12
|
-1.79 changes in scores on a scale
Standard Error 0.46
|
-1.76 changes in scores on a scale
Standard Error 0.47
|
Adverse Events
MEDI8968
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Saline
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI8968
n=55 participants at risk
SC injection
|
Saline
n=54 participants at risk
SC injection
|
|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Influenza
|
1.8%
1/55 • Number of events 1 • 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.
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.
|
0.00%
0/54 • 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.
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.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/55 • 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.
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.
|
1.9%
1/54 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Pheumonia
|
3.6%
2/55 • Number of events 2 • 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.
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.
|
0.00%
0/54 • 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.
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.
|
Other adverse events
| Measure |
MEDI8968
n=55 participants at risk
SC injection
|
Saline
n=54 participants at risk
SC injection
|
|---|---|---|
|
Infections and infestations
Pheumonia
|
5.5%
3/55 • Number of events 3 • 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.
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.
|
0.00%
0/54 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
3/55 • Number of events 3 • 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.
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.
|
3.7%
2/54 • Number of events 2 • 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.
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.
|
|
General disorders
Fatigue
|
5.5%
3/55 • Number of events 3 • 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.
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.
|
0.00%
0/54 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place