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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 Ulcerative Colitis (DUET-UC)

A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis (DUET-UC)

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

- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
- Moderately to severely active UC as assessed by the modified Mayo score
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
- If female and of childbearing potential, must meet the contraception and reproduction requirements

- Has severe extensive colitis as defined in the protocol
- Extent of inflammatory disease limited to the rectum
- Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
- 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
- Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Both

Colitis, Ulcerative

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 based on the modified Mayo subscores.

Percentage of Participants with Endoscopic Improvement at Week 48:Week 48
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.

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.

Percentage of Participants with Symptomatic Remission at Week 48:Week 48
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.

Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48:Week 48
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.

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 based on the modified Mayo subscores will be reported.

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.


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

Vital Signs Parameters Over Time:Up to Week 48
Vital signs 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 was 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 concentration 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.

Sept. 26, 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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