A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

Официальное название

A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

Обзор

The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

Подробное описание

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time following a single infusion.

Вмешательства

• Препарат Budoprutug
  Single IV dose of study product on Day 1 of study

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to Week 24]
• Incidence of Clinical Laboratory Abnormalities [Срок оценки: Up to Week 24]
• Change from Baseline in Systolic Blood Pressure [Срок оценки: Up to Week 24]
• Change from Baseline in Diastolic Blood Pressure [Срок оценки: Up to Week 24]
• Change from Baseline in Heart Rate [Срок оценки: Up to Week 24]
• Change from Baseline in Respiratory Rate [Срок оценки: Up to Week 24]
• Change from Baseline in Body Temperature [Срок оценки: Up to Week 24]
• Change from Baseline in PR Interval [Срок оценки: Up to Week 24]
• Change from Baseline in QRS Duration [Срок оценки: Up to Week 24]
• Change from Baseline in QT Interval [Срок оценки: Up to Week 24]

Вторичные конечные точки (9)

• Area Under the Curve (AUC) of Budoprutug [Срок оценки: Up to Week 24]
• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Up to Week 24]
• Time to Maximum Observed Concentration (Tmax) [Срок оценки: Up to Week 24]
• Terminal Half-Life (T1/2) [Срок оценки: Up to Week 24]
• Apparent Clearance (CL/F) of budoprutug [Срок оценки: Up to Week 24]
• Volume of Distribution (Vd) [Срок оценки: Up to Week 24]
• Change from Baseline in Circulating B Cell Count [Срок оценки: Up to Week 24]
• Incidence of Anti-Drug Antibodies (ADAs) [Срок оценки: Up to Week 24]
• ADA Titer Over Time [Срок оценки: Up to Week 24]

Критерии участия

Критерии включения

• Aged 18 to 65 years at the time of consent.
• Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
• Active, seropositive disease, with SLEDAI 2K >=8.
• Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.

Критерии исключения

• Active neuropsychiatric SLE.
• History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.
• Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Украина · 6 центров

• Climb Bio Investigative Site #380102 — Ivano-Frankivsk
• Climb Bio Investigative Site #380103 — Kyiv
• Climb Bio Investigative Site #380106 — Kyiv
• Climb Bio Investigative Site #380101 — Ternopil
• Climb Bio Investigative Site #380104 — Vinnytsia
• Climb Bio Investigative Site #380105 — Vinnytsia

США · 2 центра

• Climb Bio Investigative Site #100104 — Allen
• Climb Bio Investigative Site #100101 — San Antonio

Болгария · 2 центра

• Climb Bio Investigative Site# 359101 — Plovdiv
• Climb Bio Investigative Site# 359102 — Sofia

Грузия · 2 центра

• Climb Bio Investigative Site #995102 — Tbilisi
• Climb Bio Investigative Site #995101 — Tbilisi

Греция · 2 центра

• Climb Bio Investigative Site# 300102 — Exochi
• Climb Bio Investigative Site# 300103 — Thessaloniki

Испания · 2 центра

• Climb Bio Investigative Site# 340101 — Sabadell
• Climb Bio Investigative Site# 340102 — A Coruña

Пуэрто-Рико · 1 центр

• Climb Bio Investigative Site #100103 — Caguas

Румыния · 1 центр

• Climb Bio Investigative Site# 400101 — Cluj-Napoca

Идентификаторы

NCT: NCT07011043 · TNT119-SLE-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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