Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
TRIDENT
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
3 other identifiers
interventional
388
14 countries
147
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
Longer than P75 for phase_2
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2022
CompletedResults Posted
Study results publicly available
February 17, 2022
CompletedApril 29, 2025
April 1, 2025
4.3 years
August 19, 2016
December 10, 2021
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline to Week 8
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.
Baseline to Week 12
Secondary Outcomes (6)
Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)
Week 12
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)
Week 12
Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12
Baseline, Week 12
Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)
Week 12
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)
Week 12
- +1 more secondary outcomes
Study Arms (7)
Part I : Placebo
EXPERIMENTALParticipants 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.
Part I : JNJ-64304500
EXPERIMENTALParticipants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.
Part II : Placebo
EXPERIMENTALPlacebo 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.
Part II : JNJ-64304500 High Dose
EXPERIMENTALJNJ-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.
Part II : JNJ-64304500 Middle Dose
EXPERIMENTALJNJ-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.
Part II : JNJ-64304500 Low Dose
EXPERIMENTALJNJ-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.
Part II : Ustekinumab
EXPERIMENTALParticipants 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.
Interventions
Participants will receive JNJ-64304500 Subcutaneously.
Participants will receive ustekinumab as per the dosing regimen.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
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Lone Tree, Colorado, United States
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Coral Gables, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Indianapolis, Indiana, United States
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Houma, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Columbia, Maryland, United States
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Morristown, New Jersey, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Doylestown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Brussels, Belgium
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Ghent, Belgium
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Liège, Belgium
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Sofia, Bulgaria
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Brandon, Manitoba, Canada
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London, Ontario, Canada
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Amiens, France
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Lille, France
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Marseille, France
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Paris, France
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Pierre-BĂ©nite, France
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Saint-Etienne, France
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Toulouse, France
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Berlin, Germany
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Essen, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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LĂ¼beck, Germany
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LĂ¼neburg, Germany
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Ulm, Germany
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Budapest, Hungary
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Debrecen, Hungary
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SzekszĂ¡rd, Hungary
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Szombathely, Hungary
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Asahikawa, Japan
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Chikushino-shi, Japan
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Fukushima, Japan
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Gunma, Japan
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Hamamatsu, Japan
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Hirosaki, Japan
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Hitachi, Japan
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HyĂ´go, Japan
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Isehara, Japan
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Kagoshima, Japan
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Kahoku-gun, Japan
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Kamakura, Japan
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Kanagawa, Japan
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Kanazawa, Japan
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Kashiwa, Japan
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Midori-ku, Japan
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Minatoku, Japan
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Niigata, Japan
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Okinawa, Japan
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Osaka, Japan
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ÅŒsaka-sayama, Japan
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Saga, Japan
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Sakura, Japan
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Sapporo, Japan
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Sendai, Japan
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Shimotsuga Gun, Japan
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Shimotsuke, Japan
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Shinjuku Ku, Japan
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Shinjuku-ku, Japan
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Sunto-gun, Japan
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Bydgoszcz, Poland
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ChorzĂ³w, Poland
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Krakow, Poland
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KsawerĂ³w, Poland
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Lodz, Poland
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Oświęcim, Poland
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Poznan, Poland
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Sopot, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Włocławek, Poland
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Bucharest, Romania
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Oradea, Romania
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Timișoara, Romania
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Irkutsk, Russia
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Kazan', Russia
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Krasnoyarsk, Russia
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Moscov, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Tosno, Russia
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Yekaterinburg, Russia
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Bundang, South Korea
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Busan, South Korea
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Daegu, South Korea
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Guri-si, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Chernivtsi, Ukraine
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Dnipropetrovsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiyv, Ukraine
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Kropyvnytskyi, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Zaporizhzhia, Ukraine
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Zhaporozhia, Ukraine
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Cambridge, United Kingdom
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Nottingham, United Kingdom
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Sheffield, United Kingdom
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Sutton in Ashfield, United Kingdom
Related Publications (2)
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.
PMID: 40357993DERIVEDAllez 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.
PMID: 36939629DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- DIRECTOR CLINICAL RESEARCH GI
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
August 25, 2016
Primary Completion
December 10, 2020
Study Completion
January 24, 2022
Last Updated
April 29, 2025
Results First Posted
February 17, 2022
Record last verified: 2025-04