drugset / Trial / NCT01838499
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Phase 2
Terminated
224 enrolled
AstraZeneca
Covance · collabICON plc · collabPHT Corporation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 2013-05
- Primary completion
- 2014-10
- Completion
- 2014-10
Outcome
Missed primary endpoint
Stopped: “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.”
registry analysis (superiority or other test); MEDI8968 vs Saline; p >0.05; Difference in proportions 0.051 (80% CI -0.067 to 0.169); Mixed Models Analysis NCT01838499 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MEDI8968 | Monoclonal antibody | — | Subcutaneous |