Golimumab for Ulcerative Colitis

(PURSUIT 2 Trial)

Recruiting at 71 trial locations

Overseen By Study Contact

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Anti-TNF therapy

Disqualifiers: Liver insufficiency, Renal insufficiency, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 50 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that you must be on a stable regimen of enteral nutrition for at least 2 weeks before starting the study, which might suggest some medications could be continued.

What data supports the effectiveness of the drug Golimumab for treating ulcerative colitis?

Research shows that Golimumab, a drug that blocks a protein called tumor necrosis factor (TNF), is effective for people with moderate to severe ulcerative colitis who haven't responded to other treatments. Studies in Italy and the UK have demonstrated its ability to help patients manage their symptoms and maintain remission. ^{1 2 3 4 5}

Is golimumab safe for humans?

Golimumab, used for treating ulcerative colitis, has been studied for safety and is generally considered safe, but further research is needed to understand the risk of infections, especially in older adults and high-risk groups. ^{1 2 3 4 6}

How is the drug golimumab unique for treating ulcerative colitis?

Golimumab is unique because it is a fully human antibody that targets tumor necrosis factor (TNF) and is administered through monthly subcutaneous injections, offering an alternative for patients who do not respond to or cannot tolerate other anti-TNF drugs like infliximab and adalimumab. ^{2 3 5 7 8}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive golimumab subcutaneously or infliximab intravenously, with doses based on body surface area or weight, respectively.

50 weeks

Regular visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including endoscopic healing and clinical remission assessments.

4 weeks

Open-label extension (optional)

Participants benefiting from golimumab may continue to receive treatment in an extension period until the end of the study.

Treatment Details

Interventions

• Golimumab
• Infliximab

Trial Overview 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.

Participant Groups

Group I: Group 2: Infliximab Experimental Treatment 1 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: Golimumab Experimental Treatment 1 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:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Approved in United States as Simponi for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Approved in Canada as Simponi for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

In a study of 59 patients with moderately to severely active ulcerative colitis treated with golimumab, clinical remission rates were 47% at 12 weeks and 55% at 24 weeks, indicating that the treatment is effective for a significant portion of patients.

The safety profile of golimumab was generally favorable, with 17% of patients experiencing adverse events, primarily infections, and no significant differences in outcomes between biological naive and experienced patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers. Orlandini, B., Dragoni, G., Variola, A., et al.[2019]

Biological therapies for ulcerative colitis, including adalimumab, golimumab, infliximab, and vedolizumab, have been shown to be safe based on a comprehensive review of ten meta-analyses of randomized controlled trials.

While the evidence supports the safety of these biologics, further research is necessary to better understand the risks of infections, especially in elderly and high-risk patients, as well as the long-term effects and direct comparisons between different biologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biological therapies in ulcerative colitis: An umbrella review of meta-analyses. Bonovas, S., Pantavou, K., Evripidou, D., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Golimumab for the treatment of ulcerative colitis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis). [2022]

5. Romania pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of biological therapies in ulcerative colitis: An umbrella review of meta-analyses. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis. [2022]