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Набира участници Фаза 1 NCT07230353

A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Rheumatoid Arthritis

Спонсор: Xencor, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.
Описание
This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of plamotamab in adult participants with moderately to severely active RA. This is an open label dose optimization trial with approximately 68 participants assigned to different dose escalation cohorts.
Кой може да участва
Inclusion Criteria: Adult participants with moderately to severely active RA. * Documented diagnosis of RA and meeting the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening * Inadequate response to, loss of response to, or intolerance to available RA therapies. * Stable doses of RA medications prior to screening * Use of highly effective methods of contraception Exclusion Criteria: * Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * Recurrent infections or active clinically significant infection * Active or untreated latent tuberculosis * Cancer or history of cancer or lymphoproliferative disease within the previous 5 years * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
Места на провеждане 3
Georgia (1)
Xencor Investigative Site
Tbilisi
Moldova (1)
Xencor Investigative Site
Chisinau
New Zealand (1)
Xencor Investigative Site
Auckland
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.10.2025
Крайна дата
01.06.2028
Регистрационен номер
NCT07230353
Източник
anzctr
Запитване за медицински туризъм

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