AzTrials
AzTrials

Crohn DiseasePhase 2TRIDENTNCT02877134

Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2 study testing JNJ-64304500 and Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 147 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
JNJ-64304500 and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
388 participants
Where
147 sitesin 14 countries
Study dates
25 Aug 2016to 24 Jan 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
  • Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram 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, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
  • A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
  • Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Who cannot join

  • Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
  • Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent
  • Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
  • Participants with a history of or ongoing chronic or recurrent infectious disease
  • Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Trial locations and contacts

147 sites in 14 countries.

147 sites in 14 countries

United States37 sites

  • Study site

    Brooklyn, New York

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, Maryland

  • Study site

    Columbia, South Carolina

  • Study site

    Coral Gables, Florida

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Evanston, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Great Neck, New York

  • Study site

    Greenville, South Carolina

  • Study site

    Houma, Louisiana

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Kissimmee, Florida

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lone Tree, Colorado

  • Study site

    Marietta, Georgia

  • Study site

    Miami, Florida

  • Study site

    Miramar, Florida

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Orlando, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Richardson, Texas

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    Southlake, Texas

  • Study site

    Tyler, Texas

  • Study site

    Winter Park, Florida

Other trials in United States

Japan30 sites

  • Study site

    Asahikawa

  • Study site

    Chikushino-shi

  • Study site

    Fukushima

  • Study site

    Gunma

  • Study site

    Hamamatsu

  • Study site

    Hirosaki

  • Study site

    Hitachi

  • Study site

    Hyôgo

  • Study site

    Isehara

  • Study site

    Kagoshima

  • Study site

    Kahoku-gun

  • Study site

    Kamakura

  • Study site

    Kanagawa

  • Study site

    Kanazawa

  • Study site

    Kashiwa

  • Study site

    Midori-ku

  • Study site

    Minatoku

  • Study site

    Niigata

  • Study site

    Okinawa

  • Study site

    Osaka

  • Study site

    Ōsaka-sayama

  • Study site

    Saga

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Shimotsuga Gun

  • Study site

    Shimotsuke

  • Study site

    Shinjuku Ku

  • Study site

    Shinjuku-ku

  • Study site

    Sunto-gun

Other trials in Japan

Russia13 sites

  • Study site

    Irkutsk

  • Study site

    Kazan'

  • Study site

    Krasnoyarsk

  • Study site

    Moscov

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Tosno

  • Study site

    Yekaterinburg

Other trials in Russia

Ukraine13 sites

  • Study site

    Chernivtsi

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiyv

  • Study site

    Kropyvnytskyi

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Sumy

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Zaporizhzhya

  • Study site

    Zhaporozhia

Other trials in Ukraine

Poland12 sites

  • Study site

    Bydgoszcz

  • Study site

    Chorzów

  • Study site

    Krakow

  • Study site

    Ksawerów

  • Study site

    Lodz

  • Study site

    Oświęcim

  • Study site

    Poznan

  • Study site

    Sopot

  • Study site

    Szczecin

  • Study site

    Warsaw

  • Study site

    Włocławek

  • Study site

    Wroclaw

Other trials in Poland

Germany11 sites

  • Study site

    Berlin

  • Study site

    Essen

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Kiel

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Ludwigshafen

  • Study site

    Lüneburg

  • Study site

    Ulm

Other trials in Germany

France7 sites

  • Study site

    Amiens

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Pierre-Bénite

  • Study site

    Saint-Etienne

  • Study site

    Toulouse

Other trials in France

South Korea7 sites

  • Study site

    Bundang

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Guri-si

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Hungary4 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Szekszárd

  • Study site

    Szombathely

Other trials in Hungary

United Kingdom4 sites

  • Study site

    Cambridge

  • Study site

    Nottingham

  • Study site

    Sheffield

  • Study site

    Sutton in Ashfield

Other trials in United Kingdom

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Liège

Other trials in Belgium

Romania3 sites

  • Study site

    Bucharest

  • Study site

    Oradea

  • Study site

    Timișoara

Other trials in Romania

Canada2 sites

  • Study site

    Brandon, Manitoba

  • Study site

    London, Ontario

Other trials in Canada

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Conditions
Crohn Disease
Being tested
JNJ-64304500, Placebo, Ustekinumab
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-64304500Drug

    Participants will receive JNJ-64304500 Subcutaneously.

  • PlaceboDrug

    Participants will receive placebo Subcutaneously.

  • UstekinumabDrug

    Also called STELARA

    Participants will receive ustekinumab as per the dosing regimen.

Study groups in NCT02877134
Study groupRoleWhat they receive
Part I : PlaceboExperimentalParticipants will receive placebo Subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. From Week 12 Placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) or CDAI <150) will continue to receive placebo SC injections every 2 weeks from Week 12 through Week 22. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 400 mg SC at Week 12 and then JNJ-64304500 200 mg every two weeks from Week 14 through Week 22.
Receives: Drug: JNJ-64304500; Drug: Placebo
Part I : JNJ-64304500ExperimentalParticipants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.
Receives: Drug: JNJ-64304500
Part II : PlaceboExperimentalPlacebo SC at Weeks 0, 2, 4, and 8. From Week 12, placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in CDAI or CDAI <150) will continue to receive placebo at Weeks 12, 14, 16, and 20. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg at Weeks 14, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive placebo up to 52 weeks (for a total of up to 72 weeks of placebo in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ- 64304500. Participants receiving placebo during the LTE will stop receiving placebo.
Receives: Drug: JNJ-64304500; Drug: Placebo
Part II : JNJ-64304500 High DoseExperimentalJNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 high dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.
Receives: Drug: JNJ-64304500
Part II : JNJ-64304500 Middle DoseExperimentalJNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 middle dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.
Receives: Drug: JNJ-64304500
Part II : JNJ-64304500 Low DoseExperimentalJNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 low dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.
Receives: Drug: JNJ-64304500
Part II : UstekinumabExperimentalParticipants will receive tiered doses of Ustekinumab 260 mg (weight <=55 kg), Ustekinumab 390 mg (weight >55 kg and <=85 kg), Ustekinumab 520 mg (weight >85 kg) intravenously at Week 0 followed by 90 mg subcutaneously at Weeks 8 and 16. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive Ustekinumab up to 52 weeks (for a total of up to 72 weeks of Ustekinumab in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving Ustekinumab during the LTE will stop receiving study drug and will have a final safety follow-up visit after the last dose of study drug. However, participants receiving Ustekinumab in countries where Ustekinumab is not commercially available or approved for adult Crohn's disease were continued to receive Ustekinumab in the LTE.
Receives: Drug: Ustekinumab

What is being measured

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

  1. Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8

    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. The CDAI score was assessed by collecting information on 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 4 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: Baseline to Week 8

  2. Part II: Change From Baseline in the CDAI Score at Week 12

    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. The CDAI was assessed by collecting information on 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 4 variables are 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: Baseline to Week 12

Secondary outcomes (6)

  1. Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)

    Clinical Remission was defined as a CDAI score of <150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. 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. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

    Measured: Week 12

  2. Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)

    Clinical response was defined as a >=100-point reduction from the baseline CDAI score, or a CDAI score <150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. 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 CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

    Measured: Week 12

  3. Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12

    The PRO-2 score is defined as the sum of the abdominal pain and stool frequency components of the CDAI. PRO-2 scores ranges from 0 to approximately 300, higher score indicates higher disease activity.

    Measured: Baseline, Week 12

  4. Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)

    Clinical Remission was defined as a PRO-2 score of <75 point.

    Measured: Week 12

  5. Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)

    Clinical response was defined as >=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score <75.

    Measured: Week 12

  6. Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

    SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.

    Measured: Baseline, 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 posted24 Aug 2016 (estimated)
  2. Study start25 Aug 2016
  3. Primary completion10 Dec 2020
  4. Study completion24 Jan 2022

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
Double blind
Who is masked
Participant, Investigator
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877134
Sponsor's protocol ID
CR108136
Other IDs
64304500CRD2001, 2016-000634-21, 2016
Acronym
TRIDENT
Status last verified
Apr 2025
First submitted
19 Aug 2016
Last updated
29 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.

    PubMed 40357993

  • Allez M, Sands BE, Feagan BG, D'Haens G, De Hertogh G, Randall CW, Zou B, Johanns J, O'Brien C, Curran M, Rebuck R, Wang ML, Sabins N, Baker T, Kobayashi T. A Phase 2b, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study Evaluating the Safety and Efficacy of Tesnatilimab in Patients with Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2023 Aug 21;17(8):1235-1251. doi: 10.1093/ecco-jcc/jjad047.

    PubMed 36939629

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-64304500 and Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 147 sites in 14 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 5 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: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Japan, Russia, Ukraine, Poland and 9 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. 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 17 Feb 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?

Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. 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 NCT02877134, which also lists 2 linked publications.

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 29 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in