A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

NCT04655807 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: CR1088982020-002701-2664304500CRD2002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn's disease in response but not remission to SOC biologic therapy.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (8)

• Number of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs)

  An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline.

  Up to Week 26

• Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)

  TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  Up to Week 26

• Number of Participants with TEAEs by System Organ Class with a Frequency Threshold of 5 Percent (%) or More

  Number of participants with TEAEs by system organ class with a frequency threshold of 5 % or more will be reported.

  Up to Week 26

• Number of Participants with Infections, Serious Infections and Infections Requiring Antimicrobial Treatment

  Number of participants with infections, serious infections and infections requiring antimicrobial treatment will be reported.

  Up to Week 26

• Number of Participants with Clinically Significant Abnormalities in Vital Signs

  Number of participants with clinically significant abnormalities in vital signs will be reported.

  Up to Week 26

• Number of Participants with Clinically Significant Abnormalities in Laboratory Tests

  Number of participants with clinically significant abnormalities in laboratory tests will be reported.

  Up to Week 26

• Number of Participants with AEs Leading to Treatment Discontinuation

  Number of participants with AEs leading to treatment discontinuation will be reported.

  Up to Week 26

• Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

  Change from baseline in the CDAI score at Week 12 will be reported. CDAI will be assessed by collecting information on 7 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain/cramping 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.

  Baseline and Week 12

Secondary Outcomes (13)

• Percentage of Participants Achieving Clinical Response

  Week 12

• Percentage of Participants Achieving Clinical Remission

  Week 12

• Change from Baseline in the Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12

  Baseline and Week 12

• Percentage of Participants Achieving an Endoscopic Response

  Week 12

• Percentage of Participants Achieving an Endoscopic Remission

  Week 12

Study Arms (2)

Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab

EXPERIMENTAL

Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Drug: JNJ-64304500; Drug: Placebo; Drug: Adalimumab

Group 2: SOC Biological Therapy: Ustekinumab

EXPERIMENTAL

Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.

Drug: JNJ-64304500; Drug: Placebo; Drug: Ustekinumab

Interventions

JNJ-64304500 DRUG

JNJ-64304500 will be administered as SC injection.

Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab; Group 2: SOC Biological Therapy: Ustekinumab

Placebo DRUG

Matching placebo will be administered as SC injection.

Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab; Group 2: SOC Biological Therapy: Ustekinumab

Adalimumab DRUG

Adalimumab will be administered as SOC biological therapy.

Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab

Ustekinumab DRUG

Ustekinumab will be administered as SOC biological therapy.

Group 2: SOC Biological Therapy: Ustekinumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration
• Initiated standard of care (SOC) biologic therapy for at least 12 uninterrupted weeks (including the induction dose) prior to Week 0 and agree to continue to maintain their SOC biologic with no change in dose level or interruption for the duration of the study. Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 milligram (mg) subcutaneous (SC) every 2 weeks (q2w) plus minus (+ -) 4 days or Ustekinumab at maintenance dose of 90 mg SC every 8 weeks (q8w) + - 7 days
• Have active Crohn's disease (CD), with a baseline crohn's disease activity index (CDAI) score of greater than or equal to (\>=) 180 but less than or equal to (\<=) 400
• Participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age greater than (\>) 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance
• Participant who has had extensive colitis for \>=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
• 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 and throughout the study

You may not qualify if:

• Has complications of Crohn's disease as defined in study protocol
• Currently has or is suspected to have an abscess
• Concomitant or previous medical therapies received: has previously demonstrated suboptimal response, loss of response, or intolerance to more than 2 approved advanced therapies
• Concomitant or previous medical therapies received: corticosteroids and 5-aminosalicylic acid (5-ASA) compounds at unstable or above recommended doses are not permitted. Individuals receiving stable doses (oral corticosteroids at a prednisone-equivalent dose at or below 20 mg/day, or 6 mg/day of budesonide, 2.5 mg/day beclomethasone dipropionate, or at or below 5-ASA doses of 1.5 gram (g)/day) or if individuals have been discontinued, for at least 2 weeks before start of first study intervention (Week 0), are permitted
• Concomitant or previous medical therapies received: has received any of the following prescribed medications or therapies within the specified period or has plans to initiate throughout the study: conventional immunomodulators (that is , azathioprine \[AZA\], 6-mercaptopurine \[6 MP\], or methotrexate \[MTX\]) within 4 weeks of first dose of study intervention; oral immunomodulatory agents (example, 6-thioguanine \[6-TG\], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil, tofacitinib and other Janus kinase \[JAK\] inhibitors \[including investigational JAK inhibitors\]) less than (\<) 6 weeks or within 5 half-lives of agent before first dose of SOC biologic, whichever is longer; all other immunomodulatory biologic agents (including investigational biologics) received within 12 weeks or within 5 half-lives of first dose of SOC biologic, whichever is longer
• Infections or predisposition to infections criteria: has a stool culture or other examination positive for an enteric pathogen, including clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
• Has a transplanted organ (with exception of a corneal transplant that needs to have occurred \> 12 weeks before screening)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Medisphere Medical Research Center, Llc

Evansville, Indiana, 47714, United States

Location

Related Publications (1)

• 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: 40357993 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab; Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: November 30, 2020
• First Posted: December 7, 2020
• Study Start: March 3, 2021
• Primary Completion: May 24, 2023
• Study Completion: September 4, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)