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

NCT06408935 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: CNTO1959CRD30082023-504040-34-00
• Study Type: interventional
• Target: 120
• Locations: 14 countries
• Sites: 84

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48

  Percentage of participants achieving a MaRIA \<11 in all intestinal segments at Week 48 will be reported. The MaRIA scoring system is used to grade severity in Crohn's Disease (CD) by assessing ileocolonic CD activity on contrast-enhanced magnetic resonance imaging (MRI) enterography. Active disease is defined as a MaRIA score greater than or equal to (\>=)7 whereas severe disease is defined as a MaRIA score \>=11.

  At Week 48

Secondary Outcomes (47)

• Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.

  At Weeks 16 and 96

• Percentage of Participants Achieving a MaRIA <11 and a Reduction of >=5 Points From Baseline in All Segments at Weeks 16, 48, and 96

  At Weeks 16, 48, and 96

• Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Remission at Weeks 48 and 96

  At Week 48 and 96

• Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Response at Weeks 48 and 96.

  At Weeks 48 and 96

• Percentage of Participants Achieving a MaRIA <11 in All Segments, Patient-Reported Outcome-2 (PRO-2) Remission, and No Worsening of Abdominal Pain (AP) or Stool Frequency (SF) From Baseline

  At Weeks 16, 48 and 96

Study Arms (1)

Guselkumab

EXPERIMENTAL

Participants will receive guselkumab 200 milligram (mg) intravenously (IV) at week 0, 4 and 8. Afterwards, participants will be alternately assigned at study level to 2 dose cohorts, high dose (200 mg subcutaneous (SC) every 4 weeks (Q4W) starting at week 12) through week 92 or low dose (100 mg SC every 8 weeks (Q8W) starting at week 16) through week 88. Starting at Week 24, participants in the low-dose cohort will be permitted to escalate to the 200 mg SC Q4W regimen if they are symptomatic and at the discretion of the investigator.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered IV and SC.

Also known as: CNTO1959; TREMFYA

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (84)

Center for Colitis and Crohns Disease University of California

San Francisco, California, 94115, United States

Location

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Queen Elizabeth Hospital

Adelaide, 5011, Australia

Location

Concord Repatriation General Hospital

Concord, 2139, Australia

Location

Northern Hospital

Melbourne, 3076, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Mater Hospital Brisbane

South Brisbane, 4101, Australia

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

Vitaz

Sint-Niklaas, Belgium

Location

Cliged

Macaé, 27910-020, Brazil

Location

Instituto Mederi de Pesquisa e Saude

Passo Fundo, 99010-120, Brazil

Location

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, 90430001, Brazil

Location

INTEGRAL Pesquisa e Ensino

Votuporanga, 15501-405, Brazil

Location

Foothills Hospital

Calgary, Alberta, T2N 4Z6, Canada

Location

Western University & London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Nemocnice Ceske Budejovice a s

České Budějovice, 370 87, Czechia

Location

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

ISCARE a.s.

Prague, 19000, Czechia

Location

CHU Amiens Picardie

Amiens, 80054, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59000, France

Location

Aphm - Hopital Nord

Marseille, 13915, France

Location

CHU de Nantes hotel Dieu

Nantes, 44000, France

Location

APHP - Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Klinikum Augsburg

Augsburg, D-86158, Germany

Location

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Praxis Fur Gastroenteroligie

Berlin, 10825, Germany

Location

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, 85221, Germany

Location

Universitatsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, 60590, Germany

Location

Universitatsmedizin Gottingen

Göttingen, 37075, Germany

Location

BSF Studiengesellschaft

Halle, 06108, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitatsklinikum Schleswig Holstein

Kiel, 24105, Germany

Location

Staedtisches Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

MVZ Portal 10

Münster, 48155, Germany

Location

Siloah St Trudpert Klinikum

Pforzheim, 75179, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

The Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Hadassah Medical Organization

Jerusalem, 91200, Israel

Location

Galilee Medical Center

Nahariya, 2210001, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20121, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Universita Di Napoli Federico Ii

Naples, 80131, Italy

Location

ASL Toscana Nord Ovest PO Valdera Ospedale Lotti

Pontedera Pisa, 56025, Italy

Location

Asst Rhodense - Ospedale Di Rho

Rho, 20017, Italy

Location

Universita Campus Bio-Medico di Roma

Roma, 00128, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

Location

IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

Rozzano, 20089, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85 231, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-326, Poland

Location

GASTROMED Sp. z o.o.

Torun, 87 100, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Melita Medical Sp. z o.o.

Wroclaw, 50 449, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, 54 144, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

FNsP F.D.R. Banska Bystrica

Banská Bystrica, 975 17, Slovakia

Location

Cliniq s.r.o.

Bratislava, 811 09, Slovakia

Location

ENDOMED s.r.o

Košice, 040 13, Slovakia

Location

KM Management spol. s r.o.

Nitra, 949 01, Slovakia

Location

GASTRO I. s.r.o.

Prešov, 080 01, Slovakia

Location

Hosp. Gral. Univ. Dr. Balmis

Alicante, 3010, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Complejo Hosp Univ. de Ferrol

Ferrol, 15405, Spain

Location

Hosp. Univ. de La Paz

Ferrol, 15405, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Univ. Pta. de Hierro Majadahonda

Madrid, 28222, Spain

Location

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

Location

Chang-Hua Christian Hospital

Changhua, 500, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 22060, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Janssen Cilag Ltd. Clinical trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): March 6, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (4); BE (3); CA (3); ES (8); TW (4); AU (5); IL (7); IT (11); FR (6); PL (8); US (4); SL (5); CZ (3); DE (13)