Идёт набор NCT06624670

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

Фаза III С лечением Pyoderma Gangrenosum

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Spesolimab, Placebo matching to spesolimab, Prednisone, Prednisolone.
Кому может быть актуально: Состояния в реестре: Pyoderma Gangrenosum. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Австрия, Бельгия +16
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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) [Срок оценки: Up to Week 28.]

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

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 23 центра

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
… и ещё 15 центров

Китай · 13 центров

Peking University People's Hospital — Пекин
Peking University Third Hospital — Пекин
The First Hospital of Jilin University — Changchun
The Second Xiangya Hospital Of Central South University — Чанша
West China Hospital, Sichuan University — Чэнду
The First Affiliated Hospital, Zhejiang University — Ханчжоу
The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу
Hangzhou Third People's Hospital — Ханчжоу
… и ещё 5 центров

Германия · 8 центров

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

Япония · 8 центров

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

Италия · 6 центров

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

Канада · 5 центров

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

Австралия · 4 центра

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

Франция · 4 центра

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

Португалия · 4 центра