Golimumab for Ulcerative Colitis
(PURSUIT 2 Trial)

Recruiting in Palo Alto (17 mi)

+71 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for children with moderate to severe ulcerative colitis who are up-to-date on immunizations. They must have tried or be unable to use certain UC treatments, like corticosteroids or immunosuppressants, and can't have a history of tuberculosis. Kids dependent on steroids or those needing multiple steroid courses may join; however, those with limited UC, fistulas, stomas, contraindications to the study drugs, serious health issues including malignancies or organ insufficiency cannot participate.

Inclusion Criteria

Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0

I have been on a stable tube-feeding plan for at least 2 weeks and do not receive nutrition through my veins.

I have tried or cannot take certain medications for my condition, or I've needed multiple steroid treatments.

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Exclusion Criteria

My ulcerative colitis affects only my rectum or less than 20% of my colon.

I have or had a fistula.

I have a history of major organ or system conditions.

See 3 more

Treatment Details

Interventions

Golimumab (Monoclonal Antibodies)
Infliximab (Monoclonal Antibodies)

Trial OverviewThe trial tests if golimumab can help achieve clinical remission in kids with ulcerative colitis as measured by the Mayo score. It compares golimumab's effectiveness and safety against another medication called infliximab that targets inflammation.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Group 2: InfliximabExperimental Treatment1 Intervention

Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.

Group II: Group 1: GolimumabExperimental Treatment1 Intervention

Participants will receive subcutaneous (SC) golimumab through Week 50. Doses will be based on body surface area. Following the Week 54 evaluations (end of main pivotal study) participants who are benefiting from golimumab at the discretion of the investigator may continue to receive SC golimumab in an extension period until end of study.

Golimumab is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Simponi for: