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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102111
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: JNJ-67864238 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : May 11, 2021
Estimated Study Completion Date : May 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: JNJ-67864238
Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.
Drug: JNJ-67864238
Participants will receive oral tablets of JNJ-67864238 twice daily.

Placebo Comparator: Placebo
Participants will receive oral tablets of matching placebo twice daily for 12 weeks.
Drug: Placebo
Participants will receive oral tablets of matching placebo twice daily.




Primary Outcome Measures :
  1. Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    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) with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant in a diary. A decrease in CDAI over time indicates improvement in disease activity.


Secondary Outcome Measures :
  1. Change From Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) at Week 12 [ Time Frame: Baseline and Week 12 ]
    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 [remission] to 60 [the most severe endoscopic activity]).

  2. Percentage of Participants with Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants with clinical response at Week 12 will be assessed. Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI or CDAI less than (<) 150.

  3. Percentage of Participants with Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as a CDAI score of < 150 points.

  4. Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants with PRO-2 remission at Week 12 will be assessed. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 3.

  5. Percentage of Participants with Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants with endoscopic response at Week 12 will be assessed. Endoscopic response is defined as at least a 50 percent (%) improvement from baseline in the SES-CD.

  6. Percentage of Participants with Endoscopic Remission at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants with endoscopic remission at Week 12 will be assessed. Endoscopic remission is defined as an SES-CD score <= 2.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior exposure to an anti-IL-12/23 or anti-IL-23 antibody or related compound (including ustekinumab, risankizumab, brazikumab, guselkumab, MEDI2070, LY3074828, and related compounds)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102111


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04102111    
Other Study ID Numbers: CR108455
2018-000649-38 ( EudraCT Number )
67864238PACRD2001 ( Other Identifier: Janssen Research & Development, LLC )
PLATFORMPACRD2001 ( Other Identifier: Janssen Research & Development, LLC )
2019-003335-37 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases