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

NCT04102111 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: CR1084552018-000649-3867864238PACRD2001PLATFORMPACRD20012019-003335-37
• Study Type: interventional
• Target: 48
• Locations: 7 countries
• Sites: 63

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

  CDAI is a validated measure of illness severity derived as sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s)/opiates, and general well-being). Last 3 variables were scored over 7 days by participant on diary card. Score ranges from 0 to 600; higher score=higher disease activities. Participants who had incomplete data (less than or equal to \[\<=\]4 component values missing) at the visit, had their last available component value carried forward to calculate CDAI Score. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy or adverse event of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to corona virus disease-19 related reasons had their CDAI data as missing.

  Baseline and Week 12

Secondary Outcomes (6)

• Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

  Baseline and Week 12

• Percentage of Participants With Clinical Response at Week 12

  Week 12

• Percentage of Participants With Clinical Remission at Week 12

  Week 12

• Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12

  Week 12

• Percentage of Participants With Endoscopic Response at Week 12

  Week 12

Study Arms (2)

JNJ-67864238

EXPERIMENTAL

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

Drug: JNJ-67864238

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JNJ-67864238 DRUG

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

JNJ-67864238

Placebo DRUG

Participants will receive oral tablets of matching placebo twice daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (63)

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920, United States

Location

Gastro Florida

Clearwater, Florida, 33756, United States

Location

Gastroenterology Associates of Central GA

Macon, Georgia, 31201, United States

Location

CroNOLA, LLC

Houma, Louisiana, 70360, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

NYU Langone Long Island Clinical Research Associates

Lake Success, New York, 11042, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Northshore Gastroenterology Research, LLC

Beachwood, Ohio, 44122, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

Cer Instituto Medico

Buenos Aires, 1878, Argentina

Location

CINME Centro de Investigaciones Metabolicas

CABA, C1027AAP, Argentina

Location

Clinica Adventista Belgrano

Ciudad de Buenos Aires, C1430EGF, Argentina

Location

Sanatorio Duarte Quiroz

Córdoba, X5002AOQ, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

Location

Fundacion de Estudios Clinicos

Rosario, 2000, Argentina

Location

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

Location

Eugastro GmbH

Leipzig, 04103, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II

Ulm, 89081, Germany

Location

Policlinico di Bari Ospedale Giovanni XXIII

Bari, Italy

Location

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera G. Brotzu

Cagliari, 09134, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

Location

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

Negrar ( Ve), 37024, Italy

Location

Ospedale Maggiore della Carita

Novara, 28100, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56124, Italy

Location

Azienda Ospedaliera G.Salvini Ospedale di Rho

Rho, Italy

Location

Policinico A Gemelli

Roma, 00168, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

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

Torino, 10126, Italy

Location

Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, 15-322, Poland

Location

Endoskopia Sp z o.o.

Sopot, 81-756, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Centralny Szpital Kliniczny Mswia

Warsaw, 02 507, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04 141, Poland

Location

Immanuel Kant Baltic Federal University

Kaliningrad, 236016, Russia

Location

Kemerovo Region Clinical Hospital

Kemerovo, 650066, Russia

Location

City Hospital #13 of Avtozavodsky

Nizhny Novgorod, 603018, Russia

Location

Medical Center SibNovoMed LLC

Novosibirsk, 630005, Russia

Location

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

Rostov-on-Don, 344091, Russia

Location

International Medical Centre SOGAZ

Saint Petersburg, 191186, Russia

Location

City Hospital named after St. Martyr Elizabeth

Saint Petersburg, 195257, Russia

Location

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

Samara, 443029, Russia

Location

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, 450005, Russia

Location

Medical diagnostic centre LTD 'MDC'

Yaroslavl, 150062, Russia

Location

Medical Center Meditsinskie Tekhnologii

Yekaterinburg, 620075, Russia

Location

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

Kharkiv, 61037, Ukraine

Location

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

Kharkiv, 61039, Ukraine

Location

Kyivska miska klinichna likarnia 18

Kyiv, 01030, Ukraine

Location

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

Kyiv, 02000, Ukraine

Location

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

Location

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

Odesa, 65025, Ukraine

Location

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

Ternopil, 46002, Ukraine

Location

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

Uzhhorod, 88000, Ukraine

Location

Medical Center Ltd 'Health Clinic'

Vinnytsia, 21009, Ukraine

Location

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

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: September 23, 2019
• Primary Completion: November 17, 2021
• Study Completion: December 22, 2021
• Last Updated: February 4, 2025
• Results First Posted: December 9, 2022

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (13); IT (14); PL (5); RU (11); UA (10); AR (6); DE (4)