EudraCT 2019‐001059‐37‐DE.
Methods | Randomised, double‐blind, placebo‐controlled study |
Participants | People with bullous pemphigoid |
Interventions | Adjunctive AKST4290 versus placebo |
Outcomes | "To investigate the proportion of subjects who achieve disease control (defined as ≤ 3 new blisters/day and healing of existing blisters) following topical steroid treatment with adjunctive AKST4290 without receiving rescue therapy. To assess treatment safety of the proposed dosing regimen. Additional secondary endpoints include assessment of time to disease control; time to rescue therapy; change in BP Disease Area Index (BPDAI) score by treatment week and at disease control; and change in pruritis as assessed by the BPDAI‐Visual Analog Scale (BPDAI‐VAS) by treatment week and at disease control. In addition, change in skin (biopsy) eosinophil counts and overall steroid use required to achieve disease control will be assessed." |
Notes | Completed; no results data available in November 2021 |