Testing spesolimab for treating pyoderma gangrenosum

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of spesolimab in promoting the closure of ulcers in patients with pyoderma gangrenosum (PG). It consists of two parts: the first part randomly assigns participants to receive either spesolimab or a placebo, along with oral corticosteroids for the first eight weeks. In the second part, participants without open ulcers are again randomly assigned to receive spesolimab or placebo, while those with open ulcers will receive spesolimab. The treatment involves intravenous infusions every four weeks.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
2. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.
4. At least one measurable (defined as measuring ≥5 cm\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.
5. At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers \>6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
6. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is 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 not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
4. Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.
5. Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 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/recurrent infections 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 per local guidelines, is initiated prior to randomization and completed during the course of the trial."
7. Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
8. Severe, progressive, or uncontrolled hepatic disease, defined as \>3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or \>2x ULN elevation in total bilirubin.

Further exclusion criteria apply.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Medical Dermatology Specialists Phoenix
  Phoenix, Arizona, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Advanced Medical Research PC
  Sandy Springs, Georgia, United States Recruiting

+54 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Disclosure
• Email: clinicaldisclosure@leo-pharma.com
• Phone: +45 4494 5888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Topical ruxolitinib for adults with pyoderma gangrenosum

  This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.

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• SHR-1139 Injection for Ulcerative Pyoderma Gangrenosum in Adults

  This study tests whether SHR-1139 injections can help adults with ulcerative pyoderma gangrenosum and how safe the treatment is.

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  Recruiting at 33 sites Phase 3 LEO Pharma · Birmingham, Alabama and 32 other locations · NCT07335588

• 16-week delgocitinib cream treatment for adults with palmoplantar pustulosis

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• Evaluating Tralokinumab with Corticosteroids for Atopic Dermatitis in Children

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.