Golimumab for Ulcerative Colitis

(PURSUIT 2 Trial)

Not currently recruiting at 86 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively golimumab helps children with moderate to severe ulcerative colitis (UC) feel better and remain symptom-free. Administered as an injection, the trial will also assess its safety for these young patients. Another group will receive infliximab (also an injection) for comparison. Children who have struggled with UC and found other treatments ineffective might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for UC.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that golimumab may be safe for treating ulcerative colitis in children. Studies suggest that this medication is generally well-tolerated and remains safe with long-term use for this condition.

Golimumab is already used for other health issues, so its safety profile is well-studied. However, some concerns exist, such as the risk of serious infections or rare cancers, though these are uncommon.

For those considering joining a trial with golimumab, earlier research supports its safety. It is important to discuss any questions or concerns with a healthcare provider before making a decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Golimumab is unique for treating ulcerative colitis because it offers a convenient subcutaneous (under the skin) delivery method, which can be more comfortable and easier for patients compared to intravenous infusions. Unlike standard treatments such as infliximab, which require IV administration, golimumab allows for self-administration at home. Researchers are excited about golimumab because it targets the same inflammatory pathways but offers a potentially more flexible and patient-friendly approach to managing ulcerative colitis.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

In this trial, participants will receive either golimumab or infliximab. Previous studies have shown that golimumab holds promise for treating ulcerative colitis (UC). Research indicates that 17.8% to 17.9% of patients achieved clinical remission, with significant symptom improvement, and up to 45.1% experienced mucosal healing, which improves the gut lining, after treatment. This suggests golimumab may help reduce UC symptoms and promote gut health.

Infliximab, another treatment in this trial, has also proven effective for UC. Studies have shown that up to 79.5% of patients responded well, avoiding surgery during their hospital stay. Additionally, 26% of patients reached clinical remission in three months, offering hope for significant symptom relief. ^{1 3 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00488631

An Efficacy and Safety Study of Golimumab (CNTO 148) in ... The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5175256/

Short-term effectiveness of golimumab for ulcerative colitis This observational, prospective and multi-center study in moderate-severe ulcerative colitis patients, confirmed golimumab's short-term (14 wk) effectiveness. A ...

3. aetna.com aetna.com/cpb/medical/data/700_799/0790.html

Golimumab (Simponi and Simponi Aria) - Medical Clinical ... Golimumab was also more effective than placebo at 24 weeks in patients with PsA (ACR20, 52 % to 61 % versus 12 %, respectively; p < 0.001) (ASAS40 [40 % ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5330616/

Golimumab pharmacokinetics in ulcerative colitis Rates of clinical remission (17.8% and 17.9% respectively) and mucosal healing (42.3 and 45.1% respectively) and mean changes in IBDQ (Inflammatory Bowel ...

5. icer.org icer.org/wp-content/uploads/2020/08/ICER_Ulcerative-Colitis_Research-Protocol_12112019.pdf

Targeted Immune Modulators for Ulcerative Colitis In accordance with the revised scope, this project will assess both the comparative clinical effectiveness and economic impacts of infliximab,.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982097/

A Cohort Study in Denmark and Sweden, 2013–2021 Treatment persistence and colectomy-free outcomes in patients with ulcerative colitis receiving golimumab or adalimumab: a UK experience.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8462589/

Subcutaneous golimumab induced and maintained clinical ... Conclusion: Golimumab has shown potential efficacy and safety in the treatment of ulcerative colitis in children which may indicate a significant future role ...

8. fda.gov fda.gov/media/130843/download

Pediatric Postmarketing Pharmacovigilance Review Safety and effectiveness of SIMPONI ARIA in pediatric patients less than 18 years of age have not been established. Malignancies, some fatal, ...