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Hospital Pulau Pinang | Department of Cardiology

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

Janssen (J&J Innovative Medicine) logo

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
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

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

Trial contacts and locations

237

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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