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Monoclonal Antibodies

Golimumab for Ulcerative Colitis (PURSUIT 2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)

No history of latent or active tuberculosis prior to screening

Must not have

Have UC limited to the rectum only or to <20 percent (%) of the colon

Presence or history of a fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 54

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will evaluate whether golimumab is effective in inducing remission in children with moderate to severe ulcerative colitis, as well as assessing its safety profile.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Golimumab and infliximab might cause immune system suppression leading to infections. There could also be reactions at the infusion site (where the drug enters the body), potential activation of latent tuberculosis if present before treatment starts, and possibly other allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ulcerative colitis is moderate to severe, confirmed by a Mayo score of 6-12.

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I have never had tuberculosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have or had a fistula.

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I have a history of major organ or system conditions.

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I have had cancer, macrophage activation syndrome, or hemophagocytic lymphohistiocytosis before.

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I have a stoma.

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I cannot take golimumab, infliximab, or anti-TNF drugs due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 54 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Remission at Week 6 as Assessed by the Mayo Score

Secondary study objectives

Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6

Clinical Remission at Week 54 as Assessed by the Mayo score

Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score

+6 more

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285

14%

COLITIS ULCERATIVE

10%

NASOPHARYNGITIS

HEADACHE

OROPHARYNGEAL PAIN

COLITIS

NAUSEA

PULMONARY EMBOLISM

ACCIDENTAL OVERDOSE

100%

80%

60%

40%

20%

Study treatment Arm

Golimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Golimumab

2014

Completed Phase 4

~3610

Infliximab

2017

Completed Phase 4

~3350