Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005528-39-AT

Enrollment

550

Registered

2022-10-11

Start date

2023-06-05

Completion date

Unknown

Last updated

2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: JNJ-78934804 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Guselkumab Current Sponsor code: CNTO1959 Other descriptive name: Guselkumab Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •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 For an overview of all the inclusion criteria please refer to protocol section 5.1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •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 •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) For an overview of all the exclusion criteria please refer to protocol section 5.2

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone) ;Secondary Objective: 1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures 2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo 3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo 4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy ;Primary end point(s): Clinical remission at Week 48;Timepoint(s) of evaluation of this end point: At Week 48	—

Measure

Time frame

Main Objective: To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone) ;Secondary Objective: 1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures 2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo 3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo 4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy ;Primary end point(s): Clinical remission at Week 48;Timepoint(s) of evaluation of this end point: At Week 48

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Secondary

Measure	Time frame
Secondary end point(s): 1 Combination of histological remission and endoscopic improvement 2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo 3 Frequency and type of AEs, serious adverse events (SAEs) 4 Serum concentrations of guselkumab and golimumab over time 5 Incidence and titers of antibodies to guselkumab and golimumab 6 Incidence of neutralizing antibodies to guselkumab and golimumab ;Timepoint(s) of evaluation of this end point: 1 - At Week 48 2 - At Week 24	—

Measure

Time frame

Secondary end point(s): 1 Combination of histological remission and endoscopic improvement 2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo 3 Frequency and type of AEs, serious adverse events (SAEs) 4 Serum concentrations of guselkumab and golimumab over time 5 Incidence and titers of antibodies to guselkumab and golimumab 6 Incidence of neutralizing antibodies to guselkumab and golimumab ;Timepoint(s) of evaluation of this end point: 1 - At Week 48 2 - At Week 24

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Trials Information

Parexel International LLC

clinicaltrial.enquiries@parexel.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026