A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

Conditions

• Pyoderma Gangrenosum

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Spesolimab — DRUG
  Solution for infusion
• Placebo matching to spesolimab — DRUG
  Placebo matching to spesolimab
• Prednisone — DRUG
  Prednisone
• Prednisolone — DRUG
  Prednisolone

Study Details

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Key Dates

Start date

Feb 4, 2025

Status verified

Jun 2026

Primary completion

Nov 12, 2027

Completion

Aug 19, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Spesolimab
• Placebo Comparator: Placebo

Primary Outcome Measure

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) [ Time Frame: Up to Week 28. ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (19)

Find similar trials in Birmingham, AL

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• Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
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