Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
| Covance | INDUSTRY |
| PHT Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI8968 | Experimental |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI8968 | Biological | SC injection at baseline, Week 4 and Week 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | 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) | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert AK Lee, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | United States | |||
| Research Site |
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).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MEDI8968 | SC injection |
| FG001 | Saline | SC injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Biological | SC injection at baseline, Week 4 and Week 8 |
|
|
| Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | 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. | 12 weeks |
| Bakersfield |
| California |
| United States |
| Research Site | Fremont | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orange Park | Florida | United States |
| Research Site | Ormond Beach | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Macon | Georgia | United States |
| Research Site | Skokie | Illinois | United States |
| Research Site | West Dundee | Illinois | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Forest Hills | New York | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | High Point | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Hershey | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Rapid City | South Dakota | United States |
| Research Site | Arlington | Texas | United States |
| Research Site | Norfolk | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MEDI8968 | SC injection |
| BG001 | Saline | SC injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | FAS | Posted | Number | % of patients | 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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") | 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) | Posted | Number | % of patients | 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | 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. | FAS (LOCF) | Posted | Least Squares Mean | Standard Error | changes in scores on a scale | 12 weeks |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MEDI8968 | SC injection | 2 | 55 | 8 | 55 | ||
| EG001 | Saline | SC injection | 2 | 54 | 2 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pheumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pheumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Humphrey Gardner MD FCAP | AstraZeneca | +1 781 839 4523 | Humphrey.Gardner@astrazeneca.com |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
|
|
|
|
|