A Study With CIT-013 in RA Patients

Официальное название

A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.

Обзор

The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA. Participants will: Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Вмешательства

• Препарат CIT-013 low dose
  Subcutaneous injection
• Препарат CIT-013 high dose
  Subcutaneous injection
• Препарат Placebo
  Subcutaneous injection
• Препарат CIT-013 medium dose
  CIT-013 medium dose

Первичные конечные точки

• The change in DAS28-CRP at week 6 compared to baseline [Срок оценки: week 6]

Вторичные конечные точки (2)

• Incidence of TEAEs as assessed by CTCAE [Срок оценки: 12 weeks]
• Maximum Plasma Concentration of CIT-013 before doses [Срок оценки: 4, 6, 10 and 12 weeks]

Критерии участия

Критерии включения

• Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
• Aged 18-85
• DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
• Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.

Критерии исключения

• High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
• Contra-indication for CIT-013
• Current inflammatory joint disease other than RA (Sjogren with active disease is included).
• The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:

• ≥ 1 week for etanercept;
• ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
• ≥ 6 months year for rituximab;
• ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
• Treated with ≥ 3 bDMARD or tsDMARD
• Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.

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

Польша · 6 центров

• PL-01 — Bialystok
• PL-07 — Krakow
• PL-03 — Lublin
• PL-02 — Poznan
• PL-05 — Torun
• PL-04 — Warsaw

Испания · 6 центров

• ES-02 — A Coruña
• ES-04 — Barcelona
• ES-05 — Barcelona
• ES-06 — Madrid
• ES-01 — Santander
• ES-03 — Santiago de Compostela

Германия · 5 центров

• DE-04 — Bamberg
• DE-05 — Berlin
• DE-01 — München
• DE-02 — München
• DE-03 — Ratingen

Нидерланды · 5 центров

• NL-02 — Amsterdam
• NL-05 — Leeuwarden
• NL-04 — Leiden
• NL-03 — Nijmegen
• NL-01 — Rotterdam

Бельгия · 2 центра

• BE-02 — Antwerp
• Site BE-01 — Leuven

Идентификаторы

NCT: NCT06567470 · CITRYLL002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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