A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2025
• Main ID: NCT05528510
• Date of registration: 19/08/2022
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis ASTRO
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: September 13, 2022
• Target sample size: 418
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05528510
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, New Zealand, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Taiwan, Turkey, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent form

- 18 years of age or older

- Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening

- Moderately to severely active UC as per the modified Mayo score

- Demonstrated inadequate response to or intolerance of conventional therapy and/or
advanced therapy as defined in the protocol

Exclusion Criteria:

- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or
Crohn's disease

- Surgery within 8 weeks before screening or planned surgery during the study that may
confound the evaluation of benefit from study intervention

- Receiving prohibited medications and treatments

- UC limited to the rectum only

- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus
disease (COVID-19) infection


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Guselkumab Dose 2

Drug: Guselkumab Dose 3

Other: Placebo

Drug: Guselkumab Dose 1

Primary Outcome(s)

Clinical Remission [Time Frame: Week 12]

Secondary Outcome(s)

Clinical Response [Time Frame: Weeks 12 and 24]

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention [Time Frame: Up to Week 268]

Histologic-Endoscopic Mucosal Improvement [Time Frame: Week 12]

Clinical Remission [Time Frame: Week 24]

Endoscopic Improvement [Time Frame: Weeks 12 and 24]

Symptomatic Remission [Time Frame: Weeks 12 and 24]

Secondary ID(s)

2023-504719-34-00

2022-000365-41

CR109228

CNTO1959UCO3004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors