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

Inclusion criteria:

1. Adult trial participants, aged ≥18 years (if local legislation for age of consentdiffers, then local legislation will be followed) at screening.

2. Signed and dated written informed consent in accordance with International Councilon Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial.

3. A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on thePARACELSUS score) that requires systemic therapy in the opinion of the investigator.The diagnosis needs to be confirmed by an Adjudication Committee. Trial participantswith mixed PG subtypes are eligible as long as the target lesion is of theulcerative subtype.

4. At least one measurable (defined as measuring ≥5 cm^2) PG ulcer. In trialparticipants with more than one PG ulcer, the target PG ulcer will be selected bythe investigator and confirmed by external Adjudication Committee.

5. At the time of the Screening Visit, a maximum duration of 6 months since the targetulcer in the current PG episode was diagnosed. Target ulcers >6 months sincediagnosis are allowed if they are active and progressing, as judged by theinvestigator and confirmed by an Adjudication Committee.

6. Women of childbearing potential (WOCBP) must be ready and able to use highlyeffective methods of birth control per ICH M3 (R2) that result in a low failure rateof less than 1% per year when used consistently and correctly. A list ofcontraception methods meeting these criteria and instructions on the duration of useis provided in the participant information and in the protocol.

Exclusion criteria:

1. Trial participants with non-PG lesions.

2. Trial participants with a target PG ulcer measuring >80 cm^2.

3. Trial participants with chronic, non-inflamed PG wounds or ulcers that are notresponsive to immunosuppressive therapy, as determined by an Adjudication Committee.

4. Presence of active ulcer infection at the Screening Visit (unless treated andresolved prior to administration of the first dose of trial medication) based oninvestigator assessment.

5. Presence of persistent or recurring bacterial infection requiring systemicantibiotic therapy; or clinically significant viral, fungal, or parasitic infectionswithin 2 weeks prior to the Screening Visit. Any such infection must be resolved,with treatment completed ≥2 weeks prior to the Screening Visit. No new/recurrentinfections should have occurred prior to Visit 2.

6. "Active or latent tuberculosis (TB)

• Participants with active TB are excluded

• Participants with latent TB may be included if treatment of latent TB, as perlocal guidelines, is initiated prior to randomization and completed during thecourse of the trial."

7. Chronic or acute infections including Human immunodeficiency virus (HIV) infectionsand viral hepatitis (including occult hepatitis); the corresponding laboratory testswill be performed during screening. A trial participant can be re-screened if thetrial participant was treated and is cured from the acute infection.

8. Severe, progressive, or uncontrolled hepatic disease, defined as >3x Upper Limit ofNormal (ULN) elevation in Aspartate aminotransferase (AST) or Alanineaminotransferase (ALT) or alkaline phosphatase, or >2x ULN elevation in totalbilirubin.

Further exclusion criteria apply.