A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

NCT ID: NCT04102111

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2021-12-22

Brief Summary

The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JNJ-67864238

Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.

Group Type: EXPERIMENTAL

JNJ-67864238

Intervention Type: DRUG

Participants will receive oral tablets of JNJ-67864238 twice daily.

Placebo

Participants will receive oral tablets of matching placebo twice daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive oral tablets of matching placebo twice daily.

Interventions

JNJ-67864238

Participants will receive oral tablets of JNJ-67864238 twice daily.

Intervention Type: DRUG

Placebo

Participants will receive oral tablets of matching placebo twice daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450
• Have evidence of active ileocolonic Crohn's disease as assessed by an Simplified Endoscopic Score for Crohn's disease (SES-CD) score >=3 at screening by central endoscopy reading; or an elevated screening C-reactive protein (CRP) (greater than [>] 0.3 milligrams per deciliter [mg/dL] or 3.0 milligrams per liter [mg/L]) or an elevated screening fecal calprotectin (>250 micrograms per mg [mcg/mg])
• A participant with a family history of colorectal cancer, personal history of increased risk of colorectal cancer, age > 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). Adenomatous polyps must be removed before the first administration of the study intervention
• A woman of childbearing potential must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [beta-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Has previously demonstrated inadequate response to, loss of response to, or intolerance to an approved biologic therapy (unless otherwise specified in the JNJ-67864238 intervention cohort specific criteria, that is, anti-tumor necrosis factor (TNF) alpha agents (for example, infliximab, adalimumab, certolizumab pegol], anti- interleukin (IL)-12/23 agents [for example, ustekinumab], or anti-integrin agents [for example, vedolizumab]) or has previously demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (that is, 6-mercaptopurine [6-MP], azathioprine [AZA], and methotrexate [MTX]) but not a biologic, that is, the biologic nonfailures (Bio-NF) population
• Therapy for the treatment of Crohn's disease must include at least 1 of the following medications, which should have been maintained at stable doses prior to the baseline (Week 0) visit: (a) Oral 5-aminosalicylic acid (5-ASA) compounds; (b) Oral corticosteroids at a prednisone-equivalent dose <= 25 milligrams per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate; (c) Antibiotics being used as a primary treatment of Crohn's disease; and (d) Conventional immunomodulators (that is, AZA, 6-MP, or MTX) if participants have been taking them for at least 12 weeks and have been at a stable dose for at least 4 weeks prior to baseline

Exclusion Criteria

• Prior exposure to an anti-IL-12/23 (that is ustekinumab) or anti-IL-23 agents or related compound (including risankizumab, brazikumab, guselkumab, mirikizumab, and related compounds). Exception is made for participants who have had minimal exposure to ustekinumab at its approved labeled dosage and have met the required wash-out criteria and have not demonstrated inadequate response or intolerance to ustekinumab
• Known allergies, hypersensitivity, or intolerance to JNJ-67864238 or its excipients
• Has complications of Crohn's disease such as symptomatic strictures or stenoses, 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 JNJ-67864238
• Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
• Initiation of total (complete) or partial (supplemental) parenteral nutrition administered through any indwelling catheter less than (<) 3 weeks before baseline or anticipated to require parenteral nutrition administered through an indwelling catheter during enrollment in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Gastro Florida

Clearwater, Florida, United States

Gastroenterology Associates of Central GA

Macon, Georgia, United States

CroNOLA, LLC

Houma, Louisiana, United States

Washington University

St Louis, Missouri, United States

NYU Langone Long Island Clinical Research Associates

Lake Success, New York, United States

Columbia University Medical Center

New York, New York, United States

Northshore Gastroenterology Research, LLC

Beachwood, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Northshore Gastroenterology Research, LLC

Westlake, Ohio, United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Gastroenterology Research of San Antonio

San Antonio, Texas, United States

Cer Instituto Medico

Buenos Aires, , Argentina

CINME Centro de Investigaciones Metabolicas

CABA, , Argentina

Clinica Adventista Belgrano

Ciudad de Buenos Aires, , Argentina

Sanatorio Duarte Quiroz

Córdoba, , Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, , Argentina

Fundacion de Estudios Clinicos

Rosario, , Argentina

Universitatsklinikum Schleswig Holstein Kiel

Kiel, , Germany

Eugastro GmbH

Leipzig, , Germany

Universitaetsklinikum Mannheim

Mannheim, , Germany

Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II

Ulm, , Germany

Policlinico di Bari Ospedale Giovanni XXIII

Bari, , Italy

Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera G. Brotzu

Cagliari, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Ospedale Policlinico San Martino IRCCS

Genova, , Italy

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

Negrar ( Ve), , Italy

Ospedale Maggiore della Carita

Novara, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliera G.Salvini Ospedale di Rho

Rho, , Italy

Policinico A Gemelli

Roma, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

A.O.Citta della Salute e della Scienza di Torino

Torino, , Italy

Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, , Poland

Endoskopia Sp z o.o.

Sopot, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Centralny Szpital Kliniczny Mswia

Warsaw, , Poland

Wojskowy Instytut Medyczny

Warsaw, , Poland

Immanuel Kant Baltic Federal University

Kaliningrad, , Russia

Kemerovo Region Clinical Hospital

Kemerovo, , Russia

City Hospital #13 of Avtozavodsky

Nizhny Novgorod, , Russia

Medical Center SibNovoMed LLC

Novosibirsk, , Russia

Rostov State Medical University (RSMU) based on City Hospital No. 20

Rostov-on-Don, , Russia

International Medical Centre SOGAZ

Saint Petersburg, , Russia

City Hospital named after St. Martyr Elizabeth

Saint Petersburg, , Russia

Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'

Samara, , Russia

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , Russia

Medical diagnostic centre LTD 'MDC'

Yaroslavl, , Russia

Medical Center Meditsinskie Tekhnologii

Yekaterinburg, , Russia

MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council

Kharkiv, , Ukraine

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, , Ukraine

Kyivska miska klinichna likarnia 18

Kyiv, , Ukraine

Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC

Kyiv, , Ukraine

Danylo Halytsky Lviv National Medical University

Lviv, , Ukraine

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, , Ukraine

Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

Ternopil, , Ukraine

MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

Uzhhorod, , Ukraine

Medical Center Ltd 'Health Clinic'

Vinnytsia, , Ukraine

VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

Vinnytsia, , Ukraine

Countries

United States; Argentina; Germany; Italy; Poland; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-000649-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67864238PACRD2001

Identifier Type: OTHER

Identifier Source: secondary_id

PLATFORMPACRD2001

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003335-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108455

Identifier Type: -

Identifier Source: org_study_id