A study to test whether spesolimab helps people with a skin condition called pyoderma gangrenosum
Enrolling By Invitation
18 years - 99 years
All
Phase
3
1 Location
Brief description of study
The present trial will evaluate safety, efficacy, PK, and
immunogenicity of repeat dosing of spesolimab 900 mg i.v. vs.
placebo, both in combination with oral corticosteroid (20 mg/day
prednisone or prednisolone, which will be tapered off by Week 8) in
trial participants with ulcerative PG.
Detailed description of study
Screening: up to 42 days
Treatment: week 1-24: Spesolimab vs. Placebo (2:1 randomization), 52 weeks, i.v. every 4 weeks, week 28-52: open-label spesolimab for treatment responders or 1:1 randomization for complete responders
Follow-up: 2 visits over 2 months
Eligibility of study
You may be eligible for this study if you meet the following criteria:
