Идёт набор NCT06948318

A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Фаза III С лечением Immune Thrombocytopenic Purpura (ITP)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mezagitamab.
Кому может быть актуально: Состояния в реестре: Immune Thrombocytopenic Purpura (ITP). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Болгария, Китай, Хорватия +10
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Обзор

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time. Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met. During the study, participants will visit their study clinic several times.

Вмешательства

Препарат Mezagitamab
Mezagitamab injection administered SC.

Первичные конечные точки

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [Срок оценки: Up to approximately 108 weeks]
Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab [Срок оценки: Up to approximately 108 weeks]

Вторичные конечные точки (10)

Duration of Platelet Response [Срок оценки: Up to approximately 108 weeks]
Duration Between On-Demand Treatment Courses [Срок оценки: Up to approximately 108 weeks]
Time to Initiation of the First On-Demand Treatment Course [Срок оценки: Up to approximately 108 weeks]
Number of Participants With Complete Response [Срок оценки: Up to approximately 108 weeks]
Number of Participants With Immune Thrombocytopenia (ITP) Remission [Срок оценки: Up to approximately 108 weeks]
Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications [Срок оценки: Up to approximately 108 weeks]
Number of Participants Requiring Rescue Therapy [Срок оценки: Up to approximately 108 weeks]
Serum Concentrations of Mezagitamab [Срок оценки: Pre-dose and at multiple time points post-dose up to Week 104]
Number of Participants With Anti-Drug Antibodies (ADA) [Срок оценки: Pre-dose and at multiple time points post-dose up to Week 104]
Number of Participants With Neutralizing Antibody (NAb) [Срок оценки: Pre-dose and at multiple time points post-dose up to Week 104]

Критерии участия

Key Inclusion Criteria:

1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for "platelet response" specified for that trial during either the main study or open-label extension.

Key Exclusion criteria:

For TAK-079-3002 participants:

1\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.

For TAK-079-1004 participants:

The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
The participant has had a splenectomy within 3 months before signing the ICF.
The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies:

The last dose was received within 6 months before screening.
The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.
The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.

10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.

11\. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.

12\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.

Other protocol defined inclusion/exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Не применимо
Модель: Одна группа
Маскирование: Открытое
Основная цель: Лечение

Центры проведения

США · 21 центр

Genesis Cancer and Blood Institute - SCRI — Hot Springs
USC Norris Comprehensive Cancer Center - Keck Medicine of USC — Los Angeles
Rocky Mountain Cancer Center — Denver
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center — Washington D.C.
Emory University — Atlanta
Innovative Hematology, Inc. — Indianapolis
The University of Iowa — Iowa City
University Of Louisville Brown Cancer Center — Louisville
… и ещё 13 центров

Китай · 16 центров

Peking Union Medical College Hospital — Пекин
Guangdong Provincial People's Hospital — Гуанчжоу
The First Affiliated Hospital of Guangxi Medical University — Nanning
The First Hospital of Hebei Medical University — Shijiazhuang
Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
Henan Cancer Hospital — Чжэнчжоу
The First Affiliated Hospital of Soochow University - Shizijie Campus — Сучжоу
The First Affiliated Hospital of Nanchang University - Donghu Campus — Nanchang
… и ещё 8 центров

Япония · 13 центров

Chiba Aoba Municipal Hospital — Chuo-ku
Chibaken Saiseikai Narashino Hospital — Narashino-shi
Yokohama City University Medical Center — Yokohama
Tohoku University Hospital — Sendai
Kansai Medical University Hospital — Hirakata-shi
Hematology Ohta Clinic,Shinsaibashi — Osaka
Osaka University Hospital — Suita-shi
Saitama Medical University Hospital — Iruma-gun
… и ещё 5 центров

Италия · 11 центров

Azienda Ospedaliera Universitaria Federico II — Naples
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma — Rome
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi — Catania
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda — Milan
Fondazione IRCCS San Gerardo Dei Tintori — Monza
A.O.U. Maggiore della Carita — Novara
Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome
… и ещё 3 центра

Австралия · 10 центров

Canberra Hospital — Garran
Concord Repatriation General Hospital — Concord
St George Hospital — Kogarah
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centr — Liverpool
Westmead Hospital — Westmead
Peter MacCallum Cancer Centre — Melbourne
Monash University - Australian Centre for Blood Diseases (ACBD) — Melbourne
The Alfred Hospital — Melbourne
… и ещё 2 центра

Великобритания · 10 центров