Last updated 14 days ago
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
112 patients around the world
Available in Spain, Brazil
Janssen-Cilag Ltd.
4Research sites
112Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to 220 but less than or equal to 450 and either: Mean daily stool frequency (SF) count greater than or equal to 4, based on the unweighted CDAI component of the number of liquid or very soft stools or Mean daily AP score greater than or equal to 2, based on the unweighted CDAI component of abdominal pain (AP).Active transmural activity in at least one segment (segmental magnetic resonance index of activity [MaRIA] greater than or equal to 11).Has demonstrated inadequate response/intolerance to conventional therapy.Has previously demonstrated lack of initial response (that is, primary non-responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents).
- Has complications of Crohn's disease, such as symptomatic strictures or stenoses (unless less than 3 centimeter (cm) dilatation and not symptomatic or displaying associated fistula/fistulae and/or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified.Has had any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline.Has a draining (that is, functioning) stoma or ostomy.Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
Sites
Clínica CLIGED Macaé
Recruiting
Instituto Mederi de Pesquisa E Saude
Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
INTEGRAL Pesquisa e Ensino
Recruiting
StudyREASON
SponsorJanssen-Cilag Ltd.
Study typeInterventional
Conditions
Crohn's disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06408935
