A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis

Официальное название

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis

Обзор

The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis. The study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.

Вмешательства

• Препарат LNK01001
  Capsule; Oral
• Препарат Placebo
  Capsule; Oral

Первичные конечные точки

• Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 16 [Срок оценки: Baseline and week 16]

Вторичные конечные точки (11)

• Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 20 (ASAS20) Response at Week 16 [Срок оценки: Baseline and week 16]
• Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 16 [Срок оценки: Baseline and week 16]
• Percentage of Participants With ASDAS Inactive Disease at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Patient's Assessment of Total Back Pain at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 16 [Срок оценки: Baseline and week 16]
• Percentage of Participants With ASDAS Low Disease Activity at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 [Срок оценки: Baseline and week 16]
• Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16 [Срок оценки: Baseline and week 16]

Критерии участия

Критерии включения

• Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS.
• Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
• Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.

Критерии исключения

• Total spinal ankylosis.
• Participants with known allergies to components or excipients of the study drug.
• Requirement of prohibited medications during the study.
• Participants who are pregnant, nursing, or planning a pregnancy during the study period.

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

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07237568 · LK001302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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