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Набира участници Фаза 2/3 NCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Фаза 2/3 – комбинирано изпитване
Заболявания: Crohn Disease

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Кой може да участва
Inclusion Criteria: * Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2 * Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests * Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion criteria: * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention * Presence of a stoma or ostomy * Participants with presence of active fistulas may be included if there is no surgery needed * Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline * Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
Места на провеждане 26
Argentina (1)
GEDYT
AAI
Австралия (1)
Monash Medical Centre
Clayton
Белгия (1)
CHU Saint-Pierre
Brussels
Бразилия (1)
Hospital das Clinicas do HC/UFMG
Belo Horizonte
Канада (1)
South Edmonton Gastroenterology Research Clinic
Edmonton , Alberta
Китай (1)
Capital Medical University, Beijing Friendship Hospital
Beijing
Чехия (1)
Fakultni nemocnice Brno
Brno
Франция (1)
Centre Hospitalier de la Cote Basque
Bayonne
Германия (1)
DRK Kliniken Berlin Westend
Berlin
Гърция (1)
Evangelismos S A
Athens
Унгария (1)
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba
Индия (1)
Asian Institute Of Gastroenterology
Hyderabad
Израел (1)
Ha'Emek Medical Center
Afula
Италия (1)
ARNAS G Brotzu
Cagliari
Япония (1)
Juntendo University Hospital Urayasu
Chiba
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star
Нидерландия (1)
Vrije Universiteit Medisch Centrum
Amsterdam
Полша (1)
Centrum Medyczne Medis
Bydgoszcz
Румъния (1)
S C Delta Health Care S R L
Bucharest
Южна Корея (1)
Inje University Haeundae Paik Hospital
Busan
Испания (1)
Hosp. Clinic de Barcelona
Barcelona
Швеция (1)
Alingsas lasarett
Allingsas
Taiwan (1)
Changhua Christian Hospital
Changhua
Турция (1)
Hacettepe University Hospital
Ankara
Великобритания (1)
Queen Elizabeth Hospital Birmingham
Birmingham
САЩ (1)
AZ Gastro Care
Chandler , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.10.2025
Крайна дата
06.10.2032
Регистрационен номер
NCT07196722
Източник
anzctr
Запитване за медицински туризъм

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