Клинические исследование Immunoglobulin A (IgA) Nephropathy: Felzartamab, Placebo

Спонсоры	Ведущий спонсор: MorphoSys AG
Источник	MorphoSys AG
Краткое содержание	Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN

Общий статус

Recruiting

Дата начала

2021-08-31

Дата завершения

2024-01-01

Дата первичного завершения

2023-01-01

Фаза

Phase 2

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Efficacy: Relative change in Proteinuria value	9 months compared to baseline

Вторичный результат

Мера	Временное ограничение
Safety: determined by the frequency, incidence and severity of TEAEs	Ongoing through study completion, up to 2 years
Efficacy: Relative change in proteinuria value	Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Efficacy: complete response in patients with IgAN	Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Pharmacokinetic: serum concentrations of Felzartamab over time	Ongoing through treatment completion, up to 2 years

Регистрация

Состояние	Immunoglobulin A (IgA) Nephropathy
Вмешательство	Тип вмешательства: Drug Название вмешательства: Felzartamab Описание: anti-CD38+ monoclonal antibody Другое имя: MOR202 Тип вмешательства: Other Название вмешательства: Placebo Описание: Placebo comparator Этикетка Arm Group: Placebo
Приемлемость	Критерии: Key Inclusion Criteria: - Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country - Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF - Proteinuria at screening visit ≥ 1.0 g/d. - Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control. - A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP Key Exclusion Criteria: - Hemoglobin < 90 g/L - Thrombocytopenia: Platelets < 100.0 x 10^9/L. - Neutropenia: Neutrophils < 1.5 x 10^9/L. - Leukopenia: Leukocytes < 3.0 x 10^9/L - Diabetes mellitus type 1 - Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN Пол: All Минимальный возраст: 18 Years Максимальный возраст: 80 Years Здоровые волонтеры: No

Состояние

Immunoglobulin A (IgA) Nephropathy

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Felzartamab

Описание: anti-CD38+ monoclonal antibody

Другое имя: MOR202

Тип вмешательства: Other

Название вмешательства: Placebo

Описание: Placebo comparator

Этикетка Arm Group: Placebo

Приемлемость

Критерии:

Key Inclusion Criteria: - Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country - Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF - Proteinuria at screening visit ≥ 1.0 g/d. - Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control. - A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP Key Exclusion Criteria: - Hemoglobin < 90 g/L - Thrombocytopenia: Platelets < 100.0 x 10^9/L. - Neutropenia: Neutrophils < 1.5 x 10^9/L. - Leukopenia: Leukocytes < 3.0 x 10^9/L - Diabetes mellitus type 1 - Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

80 Years

Здоровые волонтеры:

Общий контакт

Фамилия: Morphosys Clinical Program Lead

Телефон: +498989927

Телефон доб.: 0

Расположение

Объект:	Положение дел:
FOMAT Medical Research - FOMAT - HyperCore - PPDS \| Oxnard, California, 93030-5822, United States	Active, not recruiting
Amicis Research Center, Vacaville \| Vacaville, California, 95687, United States	Active, not recruiting
MedResearch INC \| El Paso, Texas, 79935, United States	Active, not recruiting
Sunshine Hospital - Australia \| Saint Albans, Victoria, Australia	Not yet recruiting
Imelda VZW \| Bonheiden, Antwerpen, Belgium	Active, not recruiting
Regionaal Ziekenhuis Jan Yperman VZW \| Ieper, Belgium	Recruiting
University Multiprofile Hospital for Active Treatment \| Stara Zagora, Bulgaria	Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz \| Mainz, Germany	Active, not recruiting
The Catholic University of Korea, Uijeongbu St. Mary's Hospital \| Uijeongbu-Si, Korea, Republic of	Active, not recruiting
University Malaya Medical Centre \| Lembah Pantai, Malaysia	Active, not recruiting
Clinical Hospital Centar Zvezdara \| Belgrade, Serbia	Active, not recruiting
Hospital Universitari de Girona Dr Josep Trueta \| Girona, Spain	Active, not recruiting
Hospital Ruber Juan Bravo (Grupo Quironsalud) \| Madrid, Spain	Recruiting
Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis" \| Kyiv, Ukraine	Active, not recruiting
State Institution Institute of Nephrology of NAMS of Ukraine \| Kyiv, Ukraine	Recruiting
Kings College Hospital \| London, United Kingdom	Active, not recruiting

Расположение Страны	Australia Belgium Bulgaria Germany Korea, Republic of Malaysia Serbia Spain Ukraine United Kingdom United States
Дата проверки	2021-09-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	Kidney Disease Urologic Disease Glomerular Disease Berger Disease Glomerulonephritis, IGA
Имеет расширенный доступ	No
Состояние Просмотр	Kidney Diseases Glomerulonephritis, IGA
Количество рук	4
Группа вооружений	Метка: Placebo Тип: Placebo Comparator Метка: Felzartamab Arm #1 Тип: Experimental Метка: Felzartamab Arm #2 Тип: Experimental Метка: Felzartamab Arm #3 Тип: Experimental
Акроним	IGNAZ
Данные пациента	No
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy