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Trial record 4 of 7 for:    STELARA Crohn's

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02877134
First received: August 19, 2016
Last updated: December 8, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Crohn Disease
Drug: JNJ-64304500
Drug: Placebo
Drug: Ustekinumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Study 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
    The CDAI will be 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.

  • Study 2: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
    The CDAI will be 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.

  • Study 3: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
    The CDAI will be 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.


Secondary Outcome Measures:
  • Study 3: Clinical Remission at Week 8 as Measured by Crohn's Disease Activity Index (CDAI <150) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Study 3: Clinical Response at Week 8 as Measured by CDAI (>=100-point reduction from baseline in CDAI or CDAI <150) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Study 3: Change in Patient-Reported Outcome (PRO)-2 from baseline at Week 8 [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
    The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score.

  • Study 3: Clinical remission at Week 8 as measured by PRO-2 (PRO-2 <75) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Study 3: Clinical response at Week 8 as measured by PRO-2 (>=50-point reduction from baseline in PRO-2 or PRO-2 <75) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Study 3: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline at Week 12 [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 56).


Estimated Enrollment: 450
Study Start Date: August 2016
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Drug: Placebo
Participants will receive placebo Subcutaneously.
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Drug: Placebo
Participants will receive placebo Subcutaneously.
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Experimental: 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.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
Experimental: 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.
Drug: Ustekinumab
Participants will receive ustekinumab as per the dosing regimen.
Other Name: STELARA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 enrolled 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02877134

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 140 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02877134     History of Changes
Other Study ID Numbers: CR108136  64304500CRD2001  2016-000634-21 
Study First Received: August 19, 2016
Last Updated: December 8, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada - BGTD
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy and Nutrition
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Republic of Korea: Ministry of Food and Drug Safety
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Ukraine: Ministry of Health - Ukraine

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents

ClinicalTrials.gov processed this record on December 09, 2016