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Recruiting Phase 2/3 NCT07196722

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

Phase 2/3 – combined trial
Conditions: Crohn Disease

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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).
Who can participate
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
Locations 26
Argentina (1)
GEDYT
AAI
Australia (1)
Monash Medical Centre
Clayton
Belgium (1)
CHU Saint-Pierre
Brussels
Brazil (1)
Hospital das Clinicas do HC/UFMG
Belo Horizonte
Canada (1)
South Edmonton Gastroenterology Research Clinic
Edmonton , Alberta
China (1)
Capital Medical University, Beijing Friendship Hospital
Beijing
Czech Republic (1)
Fakultni nemocnice Brno
Brno
France (1)
Centre Hospitalier de la Cote Basque
Bayonne
Germany (1)
DRK Kliniken Berlin Westend
Berlin
Greece (1)
Evangelismos S A
Athens
Hungary (1)
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba
India (1)
Asian Institute Of Gastroenterology
Hyderabad
Israel (1)
Ha'Emek Medical Center
Afula
Italy (1)
ARNAS G Brotzu
Cagliari
Japan (1)
Juntendo University Hospital Urayasu
Chiba
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star
Netherlands (1)
Vrije Universiteit Medisch Centrum
Amsterdam
Poland (1)
Centrum Medyczne Medis
Bydgoszcz
Romania (1)
S C Delta Health Care S R L
Bucharest
South Korea (1)
Inje University Haeundae Paik Hospital
Busan
Spain (1)
Hosp. Clinic de Barcelona
Barcelona
Sweden (1)
Alingsas lasarett
Allingsas
Taiwan (1)
Changhua Christian Hospital
Changhua
Turkey (1)
Hacettepe University Hospital
Ankara
United Kingdom (1)
Queen Elizabeth Hospital Birmingham
Birmingham
United States (1)
AZ Gastro Care
Chandler , Arizona
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.10.2025
Completion date
06.10.2032
Registry ID
NCT07196722
Source
anzctr
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