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A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease (DUET-CD)

A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease (DUET-CD)

Sakamoto Takehiko

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Nov. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
- If female and of childbearing potential, must meet the contraception and reproduction requirements

- Complications of CD that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- Has a draining (example, functioning) stoma or ostomy
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

Both

Crohn's Disease

Guselkumab
Guselkumab will be administered as subcutaneous injection.
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Golimumab
Golimumab will be administered as subcutaneous injection.
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

JNJ-78934804 (High-dose)
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

JNJ-78934804 (Mid-dose)
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

JNJ-78934804 (Low-dose)
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Placebo
Placebo will be administered as subcutaneous injection.
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Percentage of Participants with Clinical Remission at Week 48:Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).

Percentage of Participants with Endoscopic Response at Week 48:Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD),as assessed by central endoscopy reading.

Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48:Week 48
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.

Percentage of Participants with Endoscopic Remission at Week 48:Week 48
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading.

Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48:Week 48
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.

Secondary Comparison:Percentage of Participants with Clinical Remission at Week 48:Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).

Secondary Comparison:Percentage of Participants with Endoscopic Response at Week 48:Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading.

Percentage of Participants with Adverse Events (AEs):Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Percentage of Participants with Serious Adverse Events (SAEs):Up to Week 48
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.

Clinical Laboratory Parameters Over Time:Up to Week 48
Clinical laboratory parameters over time will be reported.

Vital Sign Parameters Over Time:Up to Week 48
Vital sign parameters over time will be reported.

Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score:Up to Week 48
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline.

Serum Concentrations of Guselkumab Over Time:Up to Week 48
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.

Serum Concentrations of Golimumab Over Time:Up to Week 48
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.

Percentage of Participants with Antibodies to Guselkumab:Up to Week 48
Percentage of participants with antibodies to guselkumab will be reported.

Titers of Antibodies to Guselkumab:Up to Week 48
Titers of antibodies to guselkumab will be reported.

Percentage of Participants with Antibodies to Golimumab:Up to Week 48
Percentage of participants with antibodies to golimumab will be reported.

Titers of Antibodies to Golimumab:Up to Week 48
Titers of antibodies to golimumab will be reported.

Percentage of Participants with Neutralizing Antibodies to Guselkumab.:Up to Week 48
Percentage of participants with neutralizing antibodies to guselkumab will be reported.

Percentage of Participants with Neutralizing Antibodies to Golimumab:Up to Week 48
Percentage of participants with neutralizing antibodies to golimumab will be reported.

+81-3-6779-8166

Sept. 12, 2022

Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

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