Recruiting NCT06624670

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

Phase III Interventional Pyoderma Gangrenosum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Spesolimab, Placebo matching to spesolimab, Prednisone, Prednisolone.
Who it may be relevant to: Registry conditions: Pyoderma Gangrenosum. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +16
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Spesolimab
Solution for infusion
Drug Placebo matching to spesolimab
Placebo matching to spesolimab
Drug Prednisone
Prednisone
Drug Prednisolone
Prednisolone

Primary outcome measures

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.]

Secondary outcome measures (8)

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) [Time frame: Up to Week 28.]
Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26 [Time frame: Up to Week 26.]
Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26 [Time frame: At baseline and at Week 26.]
Achievement of a DLQI of ≤ 5 at Week 26 [Time frame: At Week 26.]
Achievement of complete response [Time frame: At Week 26.]
Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm^2 at baseline) 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.]
Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm^2 at baseline) 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.]
Time to recurrence among trial participants who had achieved CR at Week 26 up to Week 52 [Time frame: Up to Week 52.]

Eligibility criteria

Inclusion criteria

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

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.
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.
"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."
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.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 23 centers

University of Alabama at Birmingham — Birmingham
Medical Dermatology Specialists Phoenix — Phoenix
University of California Irvine — Irvine
University of Miami — Miami
University of South Florida — Tampa
Advanced Medical Research PC — Sandy Springs
Ada West Research — Meridian
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995 — Indianapolis
… and 15 more centers

China · 13 centers

Peking University People's Hospital — Beijing
Peking University Third Hospital — Beijing
The First Hospital of Jilin University — Changchun
The Second Xiangya Hospital Of Central South University — Changsha
West China Hospital, Sichuan University — Chengdu
The First Affiliated Hospital, Zhejiang University — Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
Hangzhou Third People's Hospital — Hangzhou
… and 5 more centers

Germany · 8 centers

Charité - Universitätsmedizin Berlin — Berlin
Universitätsklinikum Düsseldorf — Düsseldorf
Universitätsklinikum Erlangen — Erlangen
Universitätsklinikum Essen AöR — Essen
Universitätsklinikum Freiburg — Freiburg im Breisgau
Universitätsklinikum Hamburg, Eppendorf — Hamburg
Universitätsklinikum Tübingen — Tübingen
Universitätsklinikum Würzburg AÖR — Würzburg

Japan · 8 centers

Fujita Health University Hospital — Aichi, Toyoake
Hokkaido University Hospital — Hokkaido, Sapporo
Hyogo College of Medicine Hospital — Hyogo, Nishinomiya
Mie University Hospital — Mie, Tsu
Tohoku University Hospital — Miyagi, Sendai
Jichi Medical University Hospital — Tochigi, Shimotsuke
Teikyo University Hospital — Tokyo, Itabashi-ku
Nihon University Itabashi Hospital — Tokyo, Itabashi-ku

Italy · 6 centers

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico — Milan
Azienda Ospedaliera Universitaria Pisana — Pisa
Istituti Fisioterapici Ospitalieri — Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Istituto Clinico Humanitas — Rozzano (MI)
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino — Torino

Canada · 5 centers

Rejuvenation Dermatology Clinic — Edmonton
University of Alberta Hospital (University of Alberta) — Edmonton
Women's College Hospital — Toronto
McGill University Health Centre (MUHC) — Montreal
Centre de Recherche Saint-Louis — Québec

Australia · 4 centers

Skin and Cancer Foundation — Darlinghurst
Royal North Shore Hospital-St Leonards-20807 — St Leonards
Westmead Hospital — Westmead
Alfred Hospital — Melbourne

France · 4 centers

HOP Privé Antony — Antony
Hôpital Edouard Herriot — Lyon
Hôpital de l'Archet — Nice
HOP Saint-Louis — Paris

Portugal · 4 centers