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Crohn DiseasePhase 2PRISMNCT04102111

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

A Phase 2 study testing JNJ-67864238 in people with Crohn Disease, run by Janssen Research & Development, LLC at 63 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
JNJ-67864238
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
63 sitesin 7 countries
Study dates
23 Sep 2019to 22 Dec 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

63 sites in 7 countries.

63 sites in 7 countries

Italy14 sites

  • Policlinico di Bari Ospedale Giovanni XXIII

    Bari

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera G. Brotzu

    Cagliari, 09134

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

    Negrar ( Ve), 37024

  • Ospedale Maggiore della Carita

    Novara, 28100

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124

  • Azienda Ospedaliera G.Salvini Ospedale di Rho

    Rho

  • Policinico A Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

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

    Torino, 10126

Other trials in Italy

United States13 sites

  • Northshore Gastroenterology Research, LLC

    Beachwood, Ohio, 44122

  • Gastro Florida

    Clearwater, Florida, 33756

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • CroNOLA, LLC

    Houma, Louisiana, 70360

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York, 11042

  • Gastroenterology Associates of Central GA

    Macon, Georgia, 31201

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Columbia University Medical Center

    New York, New York, 10032

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • Washington University

    St Louis, Missouri, 63110

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

Other trials in United States

Russia11 sites

  • Immanuel Kant Baltic Federal University

    Kaliningrad, 236016

  • Kemerovo Region Clinical Hospital

    Kemerovo, 650066

  • City Hospital #13 of Avtozavodsky

    Nizhny Novgorod, 603018

  • Medical Center SibNovoMed LLC

    Novosibirsk, 630005

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

    Rostov-on-Don, 344091

  • International Medical Centre SOGAZ

    Saint Petersburg, 191186

  • City Hospital named after St. Martyr Elizabeth

    Saint Petersburg, 195257

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

    Samara, 443029

  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

    Ufa, 450005

  • Medical diagnostic centre LTD 'MDC'

    Yaroslavl, 150062

  • Medical Center Meditsinskie Tekhnologii

    Yekaterinburg, 620075

Other trials in Russia

Ukraine10 sites

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

    Kharkiv, 61037

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

    Kharkiv, 61039

  • Kyivska miska klinichna likarnia 18

    Kyiv, 01030

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

    Kyiv, 02000

  • Danylo Halytsky Lviv National Medical University

    Lviv, 79010

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

    Odesa, 65025

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

    Ternopil, 46002

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

    Uzhhorod, 88000

  • Medical Center Ltd 'Health Clinic'

    Vinnytsia, 21009

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

    Vinnytsia

Other trials in Ukraine

Argentina6 sites

  • Cer Instituto Medico

    Buenos Aires, 1878

  • CINME Centro de Investigaciones Metabolicas

    CABA, C1027AAP

  • Clinica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Sanatorio Duarte Quiroz

    Córdoba, X5002AOQ

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Fundacion de Estudios Clinicos

    Rosario, 2000

Other trials in Argentina

Poland5 sites

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Centralny Szpital Kliniczny Mswia

    Warsaw, 02 507

  • Wojskowy Instytut Medyczny

    Warsaw, 04 141

Other trials in Poland

Germany4 sites

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

  • Eugastro GmbH

    Leipzig, 04103

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

  • Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II

    Ulm, 89081

Other trials in Germany

About this study

Official title: 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.

Conditions
Crohn Disease
Being tested
JNJ-67864238, Placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-67864238Drug

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

  • PlaceboDrug

    Participants will receive oral tablets of matching placebo twice daily.

Study groups in NCT04102111
Study groupRoleWhat they receive
JNJ-67864238ExperimentalParticipants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.
Receives: Drug: JNJ-67864238
PlaceboPlacebo comparatorParticipants will receive oral tablets of matching placebo twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 12

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and Week 12

  2. 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.

    Measured: Week 12

  3. 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.

    Measured: Week 12

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Week 12

  6. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start23 Sep 2019
  3. Primary completion17 Nov 2021
  4. Study completion22 Dec 2021

Why it stopped: IAC completed review of futility analysis data \& determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102111
Sponsor's protocol ID
CR108455
Other IDs
2018-000649-38, 67864238PACRD2001, PLATFORMPACRD2001, 2019-003335-37, 2019, 2018
Acronym
PRISM
Status last verified
Jan 2025
First submitted
23 Sep 2019
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-67864238 in people with Crohn Disease, run by Janssen Research & Development, LLC at 63 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Italy, United States, Russia, Ukraine, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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