Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Официальное название

A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)

Обзор

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Подробное описание

The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).

Вмешательства

• Препарат Glepaglutide
  Subcutaneous (SC) injections twice weekly
• Другое Placebo
  SC injections twice weekly

Первичные конечные точки

• Change in weekly Parenteral Support (PS) volume [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (10)

• Proportion of participants achieving clinical response [Срок оценки: Baseline to Week 52]
• Proportion of participants achieving clinical response [Срок оценки: Baseline to Week 20 and Week 24]
• Proportion of participants with a reduction in days on PS ≥1 day/week [Срок оценки: Baseline to Week 52]
• Proportion of participants with a reduction in days on PS ≥1 day/week [Срок оценки: Baseline to Week 24]
• Proportion of participants with a reduction of 100% weekly PS volume (weaned-off) [Срок оценки: Baseline to Week 52]
• Proportion of participants with a reduction of 100% weekly PS volume (weaned-off) [Срок оценки: Baseline to Week 24]
• Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status [Срок оценки: Week 24]
• Change in weekly PS volume [Срок оценки: Baseline to Week 12]
• Change in weekly PS volume [Срок оценки: Baseline to Week 8]
• Incidence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to Week 52]

Критерии участия

Критерии включения

• Signed informed consent;
• Age of 18 to 90 years;
• A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
• Stable PS need of ≥3 days per week;
• No restorative surgery planned during the trial period;
• Having a stoma or colon in continuity.

Критерии исключения

• More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
• Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
• History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
• BMI <18.5 kg/m\^2.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Германия · 5 центров

• Universitätsmedizin Rostock — Rostock
• Eugastro Klinische Studien GmbH — Leipzig
• Charité - Universitätsmedizin Berlin — Berlin
• Universitätsklinikum Bonn — Bonn
• Asklepios Klinik St. Georg — Hamburg

США · 4 центра

• Washington University Center for Advanced Medicine — St Louis
• Lied Transplant Center at Nebraska Medical Center — Omaha
• New York Presbyterian Hospital-Columbia University Medical Center — New York
• Vanderbilt University Medical Center — Nashville

Испания · 3 центра

• Hospital General Universitario Gregorio Marañon — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Virgen del Rocio - PPDS — Seville

Польша · 2 центра

• Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi — Lodz
• Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego — Warsaw

Швеция · 2 центра

• Sahlgrenska Universitets sjukhuset — Gothenburg
• Karolinska Universitetssjukhuset Solna — Solna

Австрия · 1 центр

• Universitätsklinikum AKH Wien — Vienna

Дания · 1 центр

• Rigshospitalet-Blegdamsvej 9 — Copenhagen

Франция · 1 центр

• AP-HP - Hôpital Beaujon — Clichy

Венгрия · 1 центр

• Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika — Budapest

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS — Rome

Нидерланды · 1 центр

• Radboud Universitair Medisch Centrum — Nijmegen

Норвегия · 1 центр

• Oslo Universitetssykehus HF, Ullevål — Oslo

Идентификаторы

NCT: NCT07197944 · ZP1848-23029 · 2024-512486-14-00 · U1111-1302-6092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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