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

NCT ID: NCT02877134

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-25
• Study Completion Date: 2022-01-24

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part I : Placebo

Participants 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.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Placebo

Intervention Type: DRUG

Participants will receive placebo Subcutaneously.

Part I : JNJ-64304500

Participants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Part II : Placebo

Placebo 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.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Placebo

Intervention Type: DRUG

Participants will receive placebo Subcutaneously.

Part II : JNJ-64304500 High Dose

JNJ-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.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Part II : JNJ-64304500 Middle Dose

JNJ-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.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Part II : JNJ-64304500 Low Dose

JNJ-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.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 Subcutaneously.

Part II : Ustekinumab

Participants 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.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Participants will receive ustekinumab as per the dosing regimen.

Interventions

JNJ-64304500

Participants will receive JNJ-64304500 Subcutaneously.

Intervention Type: DRUG

Placebo

Participants will receive placebo Subcutaneously.

Intervention Type: DRUG

Ustekinumab

Participants will receive ustekinumab as per the dosing regimen.

Intervention Type: DRUG

Other Intervention Names

STELARA

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Lone Tree, Colorado, United States

Coral Gables, Florida, United States

Kissimmee, Florida, United States

Miami, Florida, United States

Miramar, Florida, United States

Orlando, Florida, United States

Winter Park, Florida, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

Evanston, Illinois, United States

Indianapolis, Indiana, United States

Houma, Louisiana, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Columbia, Maryland, United States

Morristown, New Jersey, United States

Brooklyn, New York, United States

Great Neck, New York, United States

New York, New York, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Doylestown, Pennsylvania, United States

Columbia, South Carolina, United States

Greenville, South Carolina, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Richardson, Texas, United States

San Antonio, Texas, United States

Southlake, Texas, United States

Tyler, Texas, United States

Salt Lake City, Utah, United States

Fairfax, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Brussels, , Belgium

Ghent, , Belgium

Liège, , Belgium

Sofia, , Bulgaria

Brandon, Manitoba, Canada

London, Ontario, Canada

Amiens, , France

Lille, , France

Marseille, , France

Paris, , France

Pierre-Bénite, , France

Saint-Etienne, , France

Toulouse, , France

Berlin, , Germany

Essen, , Germany

Hamburg, , Germany

Hanover, , Germany

Heidelberg, , Germany

Kiel, , Germany

Leipzig, , Germany

Ludwigshafen, , Germany

Lübeck, , Germany

Lüneburg, , Germany

Ulm, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Szekszárd, , Hungary

Szombathely, , Hungary

Asahikawa, , Japan

Chikushino-shi, , Japan

Fukushima, , Japan

Gunma, , Japan

Hamamatsu, , Japan

Hirosaki, , Japan

Hitachi, , Japan

Hyôgo, , Japan

Isehara, , Japan

Kagoshima, , Japan

Kahoku-gun, , Japan

Kamakura, , Japan

Kanagawa, , Japan

Kanazawa, , Japan

Kashiwa, , Japan

Midori-ku, , Japan

Minatoku, , Japan

Niigata, , Japan

Okinawa, , Japan

Osaka, , Japan

Ōsaka-sayama, , Japan

Saga, , Japan

Sakura, , Japan

Sapporo, , Japan

Sendai, , Japan

Shimotsuga Gun, , Japan

Shimotsuke, , Japan

Shinjuku Ku, , Japan

Shinjuku-ku, , Japan

Sunto-gun, , Japan

Bydgoszcz, , Poland

Chorzów, , Poland

Krakow, , Poland

Ksawerów, , Poland

Lodz, , Poland

Oświęcim, , Poland

Poznan, , Poland

Sopot, , Poland

Szczecin, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Włocławek, , Poland

Bucharest, , Romania

Oradea, , Romania

Timișoara, , Romania

Irkutsk, , Russia

Kazan', , Russia

Krasnoyarsk, , Russia

Moscov, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Novosibirsk, , Russia

Omsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Tosno, , Russia

Yekaterinburg, , Russia

Bundang, , South Korea

Busan, , South Korea

Daegu, , South Korea

Guri-si, , South Korea

Gyeonggi-do, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Chernivtsi, , Ukraine

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kiyv, , Ukraine

Kropyvnytskyi, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Sumy, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Zaporizhzhia, , Ukraine

Zhaporozhia, , Ukraine

Cambridge, , United Kingdom

Nottingham, , United Kingdom

Sheffield, , United Kingdom

Sutton in Ashfield, , United Kingdom

Countries

United States; Belgium; Bulgaria; Canada; France; Germany; Hungary; Japan; Poland; Romania; Russia; South Korea; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40357993 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36939629 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

64304500CRD2001

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000634-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108136

Identifier Type: -

Identifier Source: org_study_id