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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: JNJ-67864238; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1878
    • Cer Instituto Medico
  • Caba, Argentina, C1027AAP
    • CINME Centro de Investigaciones Metabólicas
  • Ciudad De Buenos Aires, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Cordoba, Argentina, X5002AOQ
    • Sanatorio Duarte Quiroz
  • Mar Del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar Del Plata
  • Rosario, Argentina, 2000
    • Fundacion de Estudios Clinicos
• Germany
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein Kiel
  • Leipzig, Germany, 04103
    • Eugastro GmbH
  • Mannheim, Germany, 68167
    • Universitaetsklinikum Mannheim
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
• Italy
  • Bari, Italy
    • Policlinico di Bari Ospedale Giovanni XXIII
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola Malpighi
  • Cagliari, Italy, 09134
    • Azienda Ospedaliera G. Brotzu
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • Negrar ( Ve), Italy, 37024
    • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
  • Novara, Italy, 28100
    • Ospedale Maggiore della Carità
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Pavia, Italy, 27100
    • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
  • Pisa, Italy, 56124
    • Azienda Ospedaliera Universitaria Pisana
  • RHO, Italy
    • Azienda Ospedaliera G.Salvini Ospedale di Rho
  • Roma, Italy, 00168
    • Policinico A Gemelli
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • A.O.Citta della Salute e della Scienza di Torino
• Poland
  • Bialystok, Poland, 15-322
    • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Sopot, Poland, 81-756
    • Endoskopia Sp z o.o.
  • Warsaw, Poland, 02 507
    • Centralny Szpital Kliniczny Mswia
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 04 141
    • Wojskowy Instytut Medyczny
• Russian Federation
  • Ekaterinburg, Russian Federation, 620075
    • Medical Center Meditsinskie Tekhnologii
  • Kaliningrad, Russian Federation, 236016
    • Immanuel Kant Baltic Federal University
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Region Clinical Hospital
  • Nizhniy Novgorod, Russian Federation, 603018
    • City Hospital #13 of Avtozavodsky
  • Novosibirsk, Russian Federation, 630005
    • Medical Center SibNovoMed LLC
  • Rostov-on-Don, Russian Federation, 344091
    • Rostov State Medical University (RSMU) based on City Hospital No. 20
  • Saint-Petersburg, Russian Federation, 195257
    • City Hospital named after St. Martyr Elizabeth
  • Samara, Russian Federation, 443029
    • Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'
  • St-Petersburg, Russian Federation, 191186
    • International Medical Centre SOGAZ
  • Ufa, Russian Federation, 450005
    • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • Yaroslavl, Russian Federation, 150062
    • Medical diagnostic centre LTD 'MDC'
• Ukraine
  • Kharkiv, Ukraine, 61039
    • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • Kharkiv, Ukraine, 61037
    • MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council
  • Kyiv, Ukraine, 02000
    • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
  • Kyiv, Ukraine, 01030
    • Kyivska miska klinichna likarnia 18
  • Lviv, Ukraine, 79010
    • Danylo Halytsky Lviv National Medical University
  • Odesa, Ukraine, 65025
    • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • Ternopil, Ukraine, 46002
    • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • Uzhgorod, Ukraine, 88000
    • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
  • Vinnytsya, Ukraine, 21009
    • Medical Center Ltd 'Health Clinic'
  • Vinnytsya, Ukraine
    • VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Peak Gastroenterology Associates
  • Florida
    • Clearwater, Florida, United States, 33756
      • Gastro Florida
  • Georgia
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central GA
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • CroNOLA, LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Lake Success, New York, United States, 11042
      • NYU Langone Long Island Clinical Research Associates
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • NorthShore Gastroenterology Research, LLC
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
    • Westlake, Ohio, United States, 44145
      • NorthShore Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists Inc
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-67864238; Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.	Drug: JNJ-67864238; Participants will receive oral tablets of JNJ-67864238 twice daily.
Placebo Comparator: Placebo; Participants will receive oral tablets of matching placebo twice daily for 12 weeks.	Drug: Placebo; Participants will receive oral tablets of matching placebo twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12	SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score= 0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score ranges=0 to 56, where higher scores=more severe disease. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy/AE of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to COVID-19 related reasons had their CDAI data as missing.	Baseline and Week 12
Percentage of Participants With Clinical Response at Week 12	Percentage of participants with clinical response at Week 12 were reported. Clinical response is defined as a greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score less than (<) 150. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	Week 12
Percentage of Participants With Clinical Remission at Week 12	Percentage of participants with clinical remission at Week 12 were reported. Clinical remission is defined as CDAI score <150. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	Week 12
Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12	Percentage of participants with PRO-2 remission at Week 12 were reported. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) <=1 and stool frequency (SF) mean daily score of <=3, that is, AP <=1 and SF <=3. PRO-2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.	Week 12
Percentage of Participants With Endoscopic Response at Week 12	Endoscopic response is defined as at least 50 percent (%) improvement from baseline in SES-CD score. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease.	Week 12
Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission defined as an SES-CD score of <=2. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease.	Week 12

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: CR108455; 2018-000649-38 (EudraCT Number); 67864238PACRD2001 (Other Identifier: Janssen Research & Development, LLC); PLATFORMPACRD2001 (Other Identifier: Janssen Research & Development, LLC); 2019-003335-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes