Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Официальное название

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Обзор

This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).

Подробное описание

The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24.

The total duration of study participation is expected to be up to 105 weeks for an individual participant.

Вмешательства

• Препарат IMVT-1402
  Administered once weekly by subcutaneous injection
• Препарат Placebo
  Administered once weekly by subcutaneous injection

Первичные конечные точки

• Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Срок оценки: Baseline and at Week 24]

Вторичные конечные точки (7)

• Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Срок оценки: Week 24]
• Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Срок оценки: Baseline, Week 24]
• Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Срок оценки: Week 24]
• Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo [Срок оценки: Week 48]
• Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo [Срок оценки: Week 48]
• Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Срок оценки: Baseline and at Week 24]
• Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Срок оценки: Baseline and at Week 24]

Критерии участия

Критерии включения

• Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
• Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
• Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
• Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Критерии исключения

• Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
• Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.

Additional exclusion criteria are defined in the protocol.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 29 центров

• Site Number - 1027 — Covina
• Site Number - 1007 — El Cajon
• Site Number - 1016 — Menifee
• Site Number - 1029 — Thousand Oaks
• Site Number - 1026 — Upland
• Site Number - 1014 — Fort Collins
• Site Number - 1018 — Hollywood
• Site Number - 1021 — Jupiter
• … и ещё 21 центр

Польша · 16 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 9 центров

• Site number - 5005 — Azcuénaga
• Site Number - 5007 — Capital Federal
• Site Number - 5008 — San Isidro
• Site Number - 5004 — San Miguel de Tucumán
• Site Number - 5000 — Buenos Aires
• Site Number - 5002 — Buenos Aires
• Site Number - 5003 — Buenos Aires
• Site Number - 5001 — Buenos Aires
• … и ещё 1 центр

Чили · 8 центров

• Site Number - 5700 — Santiago
• Site Number - 5702 — Santiago
• Site Number - 5703 — Santiago
• Site Number - 5701 — Santiago
• Site Number - 5704 — Santiago
• Site Number - 5706 — Viña del Mar
• Site Number - 5705 — Osorno
• Site Number - 5707 — Valdivia

Мексика · 8 центров

• Site Number - 2602 — Guadalajara
• … и ещё 7 центров

Германия · 7 центров

• Site Number - 6504 — Bad Doberan
• Site Number - 6506 — Cologne
• Site Number - 6500 — Hamburg
• Site Number - 6501 — Hanover
• Site Number - 6503 — Heidelberg
• Site number - 6502 — Munich
• Site Number - 6505 — Munich

Италия · 7 центров

• Site Number - 6000 — Catania
• Site Number - 6001 — Milan
• Site Number - 6006 — Naples
• Site Number - 6002 — Palermo
• Site Number - 6005 — Perugia
• Site Number - 6003 — Rome
• Site Number - 6007 — Salerno

Бразилия · 6 центров

• Site Number - 5506 — Vitória
• Site Number - 5504 — Salvador
• Site Number - 5500 — Juiz de Fora
• Site Number - 5501 — Curitiba
• Site Number - 5503 — Porto Alegre
• Site Number - 5505 — Porto Alegre

Испания · 6 центров

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Колумбия · 5 центров

• Site Number - 5800 — Medellín
• Site Number - 5804 — Barranquilla
• Site Number - 5803 — Bogotá
• Site Number - 5802 — Chía
• Site Number - 5801 — Bucaramanga

Великобритания · 5 центров

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Венгрия · 4 центра

• Site Number - 7550 — Budapest
• Site Number - 7552 — Hódmezővásárhely
• Site Number - 7551 — Kalocsa
• Site Number - 7553 — Székesfehérvár

Перу · 4 центра

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Румыния · 3 центра

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Канада · 2 центра

• Site Number - 2001 — Sherbrooke
• Site Number - 2000 — Trois-Rivières

Греция · 2 центра

• Site Number - 3901 — Athens
• Site Number - 3900 — Athens

Идентификаторы

NCT: NCT06979531 · IMVT-1402-2801 · 2025-520831-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗