Trial · NCT01838499
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
NCT01838499, Phase 2, Terminated, AstraZeneca; results first posted 2016-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa. Trials, record NCT01838499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01838499
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
- NCT number
- NCT01838499
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 224 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hidradenitis Suppurativa
- Interventions
- MEDI8968, Saline
- First posted
- 2013-04-24
- Last updated
- 2016-09-01
- Results first posted
- 2016-09-01
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 |
| 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") | 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) |
| Secondary | Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 12 weeks | FAS | % of patients | NUMBER |
| 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) | 12 weeks | % of patients | NUMBER | |
| SECONDARY | Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | 12 weeks | FAS (LOCF) | changes in scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | MEDI8968 | Responders (%) | 23.6 | % 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 | Saline | Responders (%) | 18.5 | % 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 | MEDI8968 | Non-responders (%) | 76.4 | % 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 | Saline | Non-responders (%) | 81.5 | % 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) | MEDI8968 | Responders (%) | 49.1 | % 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) | Saline | Responders (%) | 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) | MEDI8968 | Non-Responders (%) | 50.9 | % 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) | Saline | Non-Responders (%) | 44.4 | % of patients | |
| Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | MEDI8968 | Week 4 | -1.09 | Standard Error 0.35 | changes in scores on a scale |
| Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain | Saline | Week 4 | -1.02 | Standard Error 0.36 | changes in scores on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MEDI8968 | 55 | |
| Overall Study | STARTED | Saline | 54 | |
| Overall Study | COMPLETED | MEDI8968 | 31 | |
| Overall Study | COMPLETED | Saline | 37 | |
| Overall Study | NOT COMPLETED | MEDI8968 | 24 | |
| Overall Study | NOT COMPLETED | Saline | 17 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pheumonia | Infections and infestations | MEDI8968 | 3 | 55 | 3 |
| other | Pheumonia | Infections and infestations | Saline | 0 | 54 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | MEDI8968 | 3 | 55 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Saline | 2 | 54 | 2 |
| other | Fatigue | General disorders | MEDI8968 | 3 | 55 | 3 |
| other | Fatigue | General disorders | Saline | 0 | 54 | 0 |
| serious | Bacteraemia | Infections and infestations | MEDI8968 | 0 | 55 | 0 |
| serious | Bacteraemia | Infections and infestations | Saline | 1 | 54 | 1 |
| serious | Bacterial infection | Infections and infestations | MEDI8968 | 0 | 55 | 0 |
| serious | Bacterial infection | Infections and infestations | Saline | 1 | 54 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI8968 | ||
| Total, all-cause mortality | Saline | ||
| Total, other adverse events | MEDI8968 | 8 | 55 |
| Total, other adverse events | Saline | 2 | 54 |
| Total, serious adverse events | MEDI8968 | 2 | 55 |
| Total, serious adverse events | Saline | 2 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MEDI8968 vs Saline: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01838499
GET https://conductscience.org/api/trials/v1/NCT01838499/events?page=2