RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Spesolimab for Pyoderma Gangrenosum

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT06624670 · LEO Pharma · enrollment listed as 90

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Spesolimab, Placebo matching to spesolimab, or Prednisone. The registry lists allocation as randomized. This study wants to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG).

They plan to enroll about 90 people at 104 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Spesolimab, Placebo matching to spesolimab, Prednisone, Prednisolone

Primary outcome (registry wording): 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)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
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

Who the registry excludes

Trial participants with non-PG lesions
Trial participants with a target PG ulcer measuring \>80 cm\^2
Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee
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
"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."

Public study contact (from the registry)

Clinical Disclosure

+45 4494 5888

clinicaldisclosure@leo-pharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

104 listed

University of Alabama at Birmingham — Birmingham, Alabama (recruiting)
Medical Dermatology Specialists Phoenix — Phoenix, Arizona (recruiting)
University of California Irvine — Irvine, California (recruiting)
University of Miami — Miami, Florida (recruiting)
University of South Florida — Tampa, Florida (recruiting)
Advanced Medical Research PC — Sandy Springs, Georgia (recruiting)
Ada West Research — Meridian, Idaho (recruiting)
DeNova Research — Chicago, Illinois (not_yet_recruiting)
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995 — Indianapolis, Indiana (recruiting)
Tulane University Hospital and Clinic — New Orleans, Louisiana (recruiting)
Brigham and Women's Hospital — Boston, Massachusetts (recruiting)
University of Michigan — Ann Arbor, Michigan (recruiting)

+ 78 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06624670 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06624670?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06624670?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary