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Crohn DiseasePhase 2DUETNCT04655807

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

A Phase 2 study testing JNJ-64304500, Adalimumab and Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Crohn Disease
What is being tested?
JNJ-64304500, Adalimumab and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Mar 2021to 4 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medisphere Medical Research Center, Llc

    Evansville, Indiana, 47714

Other trials in United States

About this study

Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease

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.

Read the detailed description

Biologic agents such as anti-tumor necrosis factor (TNF) and interleukin (IL)-12/23 antagonists have become the standard of care (SOC) in the treatment of patients with Crohn's disease. However, many patients fail to fully respond to treatment. This study will evaluate the efficacy of 10 week add on treatment with JNJ-64304500, compared to placebo, in patients taking SOC anti-TNF or anti-IL12/23 biologics. The study consists of a screening phase (up to 8 weeks); treatment phase (up to 12 weeks and follow-up phase (up to 16 weeks after the last administration of study agent). The total study duration will be up to 34 weeks. Key safety assessments include adverse events, clinical laboratory tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis.

Conditions
Crohn Disease
Being tested
JNJ-64304500, Placebo, Adalimumab, Ustekinumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64304500Drug

    JNJ-64304500 will be administered as SC injection.

  • PlaceboDrug

    Matching placebo will be administered as SC injection.

  • AdalimumabDrug

    Adalimumab will be administered as SOC biological therapy.

  • UstekinumabDrug

    Ustekinumab will be administered as SOC biological therapy.

Study groups in NCT04655807
Study groupRoleWhat they receive
Group 1- Standard of Care (SOC) Biological Therapy: AdalimumabExperimentalParticipants 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.
Receives: Drug: JNJ-64304500; Drug: Placebo; Drug: Adalimumab
Group 2: SOC Biological Therapy: UstekinumabExperimentalParticipants 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.
Receives: Drug: JNJ-64304500; Drug: Placebo; Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Week 26

  2. 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.

    Measured: Up to Week 26

  3. 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.

    Measured: Up to Week 26

  4. 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.

    Measured: Up to Week 26

  5. Number of Participants with Clinically Significant Abnormalities in Vital Signs

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

    Measured: Up to Week 26

  6. Number of Participants with Clinically Significant Abnormalities in Laboratory Tests

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

    Measured: Up to Week 26

  7. Number of Participants with AEs Leading to Treatment Discontinuation

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

    Measured: Up to Week 26

  8. 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.

    Measured: Baseline and Week 12

Secondary outcomes (13)

  1. Percentage of Participants Achieving Clinical Response

    Percentage of participants achieving a clinical response as measured by CDAI score (including greater than or equal to [>=] 50, >=70, >=100, and >=150 point reduction from baseline in CDAI) will be reported.

    Measured: Week 12

  2. Percentage of Participants Achieving Clinical Remission

    Percentage of participants achieving a clinical remission as measured by CDAI score (CDAI less than [<] 150) will be reported.

    Measured: Week 12

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

    Change from baseline in the SES-CD score at Week 12 will be reported. 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).

    Measured: Baseline and Week 12

  4. Percentage of Participants Achieving an Endoscopic Response

    Percentage of participants achieving an endoscopic response defined as at least a 50% improvement from baseline in the SES-CD.

    Measured: Week 12

  5. Percentage of Participants Achieving an Endoscopic Remission

    Percentage of participants achieving an endoscopic remission defined as an SES-CD score less than or equal to (<=) 2.

    Measured: Week 12

  6. Change From Baseline in Abdominal Pain (AP)

    Change in AP from baseline based on a 0 to 10 numerical rating scale (NRS) will be reported. A score of 0 represents "no abdominal pain" and a score of 10 represents the "worst possible AP," with greater scores indicating greater pain severity and intensity.

    Measured: Baseline up to Week 12

  7. Percentage of Participants Achieving Patient-Reported Outcome (PRO)-2 Remission

    Percentage of participants achieving a PRO-2 remission defined as AP mean daily score (AP component of the CDAI score) at or below 1 and stool frequency (SF) mean daily score at or below 3, that is, AP <=1 and SF <=3.

    Measured: Week 12

  8. Serum Concentrations of JNJ-64304500

    Serum concentrations of JNJ-64304500 will be reported.

    Measured: Up to Week 26

  9. Number of Participants with Antibodies to JNJ-64304500

    Antibody titers binding to JNJ-64304500 in positive samples will be reported.

    Measured: Up to Week 26

  10. Number of Participants with Neutralizing Antibodies to JNJ-64304500

    Number of participants receiving at least one dose of JNJ-64304500 with neutralizing antibodies to JNJ-64304500 will be summarized.

    Measured: Up to Week 26

  11. Change in Pharmacodynamics (PD) Biomarker Levels of C-Reactive Protein (CRP) from Baseline Compared with Placebo

    Change in PD biomarker levels of CRP from baseline compared with placebo will be reported.

    Measured: Baseline, up to Week 26

  12. Change in PD Biomarker Levels of Fecal Calprotectin from Baseline Compared with Placebo

    Change in PD biomarker levels of fecal calprotectin from baseline compared with placebo will be reported.

    Measured: Baseline, up to Week 26

  13. Change in PD Biomarker Levels of Fecal Lactoferrin from Baseline Compared with Placebo

    Change in PD biomarker levels of fecal lactoferrin from baseline compared with placebo will be reported.

    Measured: Baseline, up to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start3 Mar 2021 (estimated)
  3. Primary completion24 May 2023 (estimated)
  4. Study completion4 Sep 2023 (estimated)

Why it stopped: Sponsor Decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04655807
Sponsor's protocol ID
CR108898
Other IDs
2020-002701-26, 64304500CRD2002
Acronym
DUET
Status last verified
Apr 2025
First submitted
30 Nov 2020
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40357993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-64304500, Adalimumab and Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Week 26). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04655807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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