Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis

Официальное название

A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis

Обзор

Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1). ABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is "double-blind", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world. Participants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат ABBV-142
  ABBV-142
• Препарат Placebo for ABBV-142
  Placebo for ABBV-142

Первичные конечные точки

• Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [Срок оценки: Week 24]
• Percentage of Participants with Adverse Events (AE) [Срок оценки: Up to approximately 52 weeks]

Вторичные конечные точки (10)

• Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [Срок оценки: Week 52]
• Relative Change From Baseline in FVC (mL) [Срок оценки: Week 24]
• Relative Change From Baseline in FVC (ml) [Срок оценки: Week 52]
• Absolute Change from Baseline in FVC% predicted [Срок оценки: Up to approximately 52 weeks]
• Relative Change From Baseline in FVC% predicted [Срок оценки: Up to approximately 52 weeks]
• Change From Baseline in Living with Pulmonary Fibrosis (L-PF) Overall Score [Срок оценки: Up to approximately 52 weeks]
• Time to First Absolute Decline From Baseline in FVC% Predicted of >= 10% [Срок оценки: Up to approximately 52 weeks]
• Time to First Relative Decline From Baseline in FVC% Predicted of >= 10% [Срок оценки: Up to approximately 52 weeks]
• Time to First Absolute Decline From Baseline in FVC% Predicted >= 5% [Срок оценки: Up to approximately 52 weeks]
• Time to First Relative Decline From Baseline in FVC% Predicted >= 5% [Срок оценки: Up to approximately 52 weeks]

Критерии участия

Критерии включения

\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.

Критерии исключения

• History of stroke within 6 months prior to screening
• In the opinion of the investigator, other clinically significant pulmonary abnormalities
• History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.

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

США · 3 центра

• Sec Clinical Research - East - Dothan - Graceland /ID# 278328 — Dothan
• Christie Clinic on University /ID# 277871 — Champaign
• Hannibal Regional Hospital /ID# 277984 — Hannibal

Тайвань · 2 центра

• Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 — Kaohsiung City
• China Medical University Hospital /ID# 278039 — Taichung

Канада · 1 центр

• Centre d'Investigation Clinique Mauricie /ID# 277949 — Trois-Rivières

Идентификаторы

NCT: NCT07230288 · M25-268 · 2024-518013-25-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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