A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

Официальное название

A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)

Обзор

The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \[DM\] or polymyositis \[PM\]). Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM. DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash. These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work. This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up. The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months. There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.

Вмешательства

• Препарат Dazukibart
  anti-interferon beta therapy

Первичные конечные точки

• Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation [Срок оценки: 52 weeks]
• Number of participants with clinically significant laboratory abnormalities [Срок оценки: 52 weeks]
• Number of participants with clinically significant abnormalities in vital signs [Срок оценки: 52 weeks]
• Number of participants with clinically significant electrocardiogram (ECG) abnormalities [Срок оценки: 52 weeks]
• Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [Срок оценки: 52 weeks]
• Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: 52 weeks]

Вторичные конечные точки (12)

• Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) [Срок оценки: 52 weeks]
• Change from baseline in Physician Global Activity (PhGA) [Срок оценки: 52 weeks]
• Change from baseline in extramuscular activity or disease activity score and muscle enzyme results [Срок оценки: 52 weeks]
• Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score [Срок оценки: 52 weeks]
• Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants [Срок оценки: 52 weeks]
• Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants [Срок оценки: 52 weeks]
• Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) [Срок оценки: 52 weeks]
• Change from baseline in Patient Global Activity (PtGA) [Срок оценки: 52 weeks]
• Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [Срок оценки: 52 weeks]
• Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Срок оценки: 52 weeks]
• Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS) [Срок оценки: 52 Weeks]
• Change from baseline in Healthcare Resource Utilization Questionnaire (HRU) [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

• Participants that completed a qualifying study through Week 52.

Критерии исключения

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
• Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).
• Current use of any prohibited concomitant medication(s).
• Active bacterial, viral, fungal, mycobacterial or other infections.
• Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.
• Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Anhui Provincial Hospital — Хэфэй
• The Second Affiliated Hospital of Nanchang University — Nanchang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• Renji Hospital Shanghai Jiao Tong University School of Medicine — Шанхай
• Renji Hospital Shanghai Jiao Tong University School of Medicine — Шанхай
• First Affiliated Hospital of Kunming Medical University — Куньмин
• Peking Union Medical College Hospital — Пекин

США · 4 центра

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale
• Arthritis & Rheumatology Research Institute, PLLC — Allen
• Nerve & Muscle Center of Texas — Houston
• Rheumatology & Pulmonary Clinic — Beckley

Япония · 2 центра

• Institute of Science Tokyo Hospital — Bunkyo-ku
• Nippon Medical School Hospital — Bunkyo-ku

Польша · 2 центра

• Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji — Warsaw
• Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty — Bialystok

Тайвань · 2 центра

• Chi Mei Medical Center — Tainan
• National Taiwan University Hospital — Taipei

Аргентина · 1 центр

• Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman

Болгария · 1 центр

• Medical Center Artmed — Plovdiv

Венгрия · 1 центр

• Debreceni Egyetem Klinikai Kozpont — Debrecen

Индия · 1 центр

• CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited) — Ernākulam

Израиль · 1 центр

• Sheba Medical Center — Ramat Gan

Мексика · 1 центр

• Cryptex Investigación Clínica S.A. de C.V. — Cuauhtémoc

Turkey (Türkiye) · 1 центр

• Hacettepe Universite Hastaneleri — Altindağ

Идентификаторы

NCT: NCT06698796 · C0251010 · 2024-514648-10-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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