A multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial to evaluate safety and efficacy of spesolimab (BI 655130) in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy

Conditions

Pyoderma gangrenosum

Brief summary

Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)

Detailed description

Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later), Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26, Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26, Achievement of a DLQI of ≤ 5 at Week 26, Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52. Recurrence is defined as emergence of the disease (PG ulcer[s]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s)

Related papers

No related papers found yet.

Interventions

DRUGPlacebo matching to spesolimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)	—

Secondary

Measure	Time frame
Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later), Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26, Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26, Achievement of a DLQI of ≤ 5 at Week 26, Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52. Recurrence is defined as emergence of the disease (PG ulcer[s]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s)	—

Measure

Time frame

Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later), Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26, Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26, Achievement of a DLQI of ≤ 5 at Week 26, Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later), Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52. Recurrence is defined as emergence of the disease (PG ulcer[s]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s)

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Countries

Austria, Belgium, Finland, France, Germany, Italy, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed