Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients (REASON)

Last Updated March 5, 2025

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CNTO1959CRD3008

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 3

3
Sites
41 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

CONDITIONS

Crohn's Disease

ELIGIBILITY

Inclusion Criteria:

* 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 <=450 and either: a. Mean daily stool frequency (SF) count >=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >=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] >= 11)
* a. Has demonstrated inadequate response/intolerance to conventional therapy; b. 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)

Exclusion Criteria:

* 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 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

Israel, Taiwan, Canada, Czechia, Germany, Italy, Poland, Slovakia, Spain

Country (9)	City or Province (41)	Status
Israel	Haifa Rambam Medical Center	RECRUITING
Israel	Jerusalem Hadassah Medical Organization	RECRUITING
Israel	Nahariya Galilee Medical Center	RECRUITING
Israel	Petah Tikva Rabin Medical Center	RECRUITING
Israel	Ramat Gan The Chaim Sheba Medical Center	RECRUITING
Israel	Tel Aviv Tel Aviv Sourasky Medical Center	RECRUITING
Taiwan	Taipei National Taiwan University Hospital	RECRUITING
Israel	Holon The Edith Wolfson Medical Center	RECRUITING
Taiwan	Taipei Taipei Veterans General Hospital	RECRUITING
Canada	London Western University & London Health Sciences Centre	RECRUITING
Czechia	Ceske Budejovice Nemocnice Ceske Budejovice a s	RECRUITING
Czechia	Hradec Kralove Hepato-gastroenterologie HK, s.r.o.	RECRUITING
Czechia	Praha 9 ISCARE a.s.	RECRUITING
Germany	Augsburg Klinikum Augsburg	RECRUITING
Germany	Berlin Charite Universitaetsmedizin Berlin	RECRUITING
Germany	Berlin Praxis Für Gastroenteroligie	RECRUITING
Germany	Dachau Medizinisches Versorgungszentrum (MVZ) Dachau	RECRUITING
Germany	Frankfurt Universitatsklinikum Frankfurt/ Medizinische Klinik 1	RECRUITING
Germany	Gottingen Universitatsmedizin Gottingen	RECRUITING
Germany	Hannover Medizinische Hochschule Hannover	RECRUITING
Germany	Kiel Universitatsklinikum Schleswig Holstein	RECRUITING
Germany	Lüneburg Staedtisches Klinikum Lueneburg	RECRUITING
Germany	Ulm Universitaetsklinikum Ulm	RECRUITING
Italy	Milano IRCCS Ospedale San Raffaele	RECRUITING
Italy	Roma Fondazione Policlinico Universitario A Gemelli IRCCS	RECRUITING
Poland	Bydgoszcz NZOZ Centrum Medyczne KERmed	RECRUITING
Poland	Rzeszow Centrum Medyczne Medyk	RECRUITING
Poland	Torun GASTROMED Sp. z o.o.	RECRUITING
Poland	Warszawa WIP Warsaw IBD Point Profesor Kierkus	RECRUITING
Poland	Wroclaw Centrum Medyczne Oporow	RECRUITING
Poland	Wroclaw EuroMediCare Szpital Specjalistyczny z Przychodnia	RECRUITING
Poland	Zamosc ETG Zamosc	RECRUITING
Slovakia	Banska Bystrica FNsP F.D.R. Banska Bystrica	RECRUITING
Spain	Alicante Hosp. Gral. Univ. Dr. Balmis	RECRUITING
Spain	Ferrol Hosp. Univ. de La Paz	RECRUITING
Spain	Madrid Hosp. Univ. de La Princesa	RECRUITING
Spain	Madrid Hosp. Univ. Pta. de Hierro Majadahonda	RECRUITING
Spain	Valencia Hosp. Clinico Univ. de Valencia	RECRUITING
Spain	Vigo Hosp. Alvaro Cunqueiro	RECRUITING
Taiwan	Changhua Chang-Hua Christian Hospital	RECRUITING
Taiwan	New Taipei Far Eastern Memorial Hospital	RECRUITING

Geo Locations

32.81841, 34.9885

31.76904, 35.21633

33.00892, 35.09814

32.08707, 34.88747

32.08227, 34.81065

32.08088, 34.78057

25.04776, 121.53185

32.01034, 34.77918

25.04776, 121.53185

42.98339, -81.23304

48.97447, 14.47434

50.20923, 15.83277

50.08804, 14.42076

48.37154, 10.89851

52.52437, 13.41053

48.26, 11.43402

50.11552, 8.68417

51.53443, 9.93228

52.37052, 9.73322

54.32133, 10.13489

53.2509, 10.41409

48.39841, 9.99155

45.46427, 9.18951

41.89193, 12.51133

53.1235, 18.00762

50.04132, 21.99901

53.01375, 18.59814

52.22977, 21.01178

51.1, 17.03333

50.72314, 23.25196

48.73946, 19.15349

38.34517, -0.48149

43.4896, -8.21942

40.4165, -3.70256

39.46975, -0.37739

42.23282, -8.72264

24.07327, 120.56276

25.01111, 121.44583

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

32.81841, 34.9885

31.76904, 35.21633

33.00892, 35.09814

32.08707, 34.88747

32.08227, 34.81065

32.08088, 34.78057

25.04776, 121.53185

32.01034, 34.77918

25.04776, 121.53185

42.98339, -81.23304

48.97447, 14.47434

50.20923, 15.83277

50.08804, 14.42076

48.37154, 10.89851

52.52437, 13.41053

52.52437, 13.41053

48.26, 11.43402

50.11552, 8.68417

51.53443, 9.93228

52.37052, 9.73322

54.32133, 10.13489

53.2509, 10.41409

48.39841, 9.99155

45.46427, 9.18951

41.89193, 12.51133

53.1235, 18.00762

50.04132, 21.99901

53.01375, 18.59814

52.22977, 21.01178

51.1, 17.03333

51.1, 17.03333

50.72314, 23.25196

48.73946, 19.15349

38.34517, -0.48149

43.4896, -8.21942

40.4165, -3.70256

40.4165, -3.70256

39.46975, -0.37739

42.23282, -8.72264

24.07327, 120.56276

25.01111, 121.44583

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