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

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3

Conditions: Colitis, Ulcerative

Treatments: Drug: Guselkumab Dose 2; Other: Placebo; Drug: Guselkumab Dose 3; Drug: Guselkumab Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05528510

2023-504719-34-00 (Registry Identifier)

2022-000365-41 (EudraCT Number)

CR109228

CNTO1959UCO3004 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Full description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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418 participants in 3 patient groups, including a placebo group

Group 1: Guselkumab

Experimental group

Description:

Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Treatment:

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 2

Group 2: Guselkumab

Experimental group

Description:

Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Treatment:

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 3

Group 3: Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo SC injection.

Treatment:

Other: Placebo