Combination Therapy for Ulcerative Colitis

(DUET-UC Trial)

Recruiting at 543 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Crohn's disease, Malignancy, Chronic infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 44 weeks

577 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication, JNJ-78934804, for patients with severe ulcerative colitis who haven't had success with other treatments. The medication aims to reduce inflammation by targeting the immune system.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug combination therapy for ulcerative colitis?

Research shows that golimumab, a component of the combination therapy, is effective in treating moderate-to-severe ulcerative colitis, helping patients achieve clinical response and remission. Additionally, a study suggests that combining guselkumab with golimumab may be more effective than using either drug alone for ulcerative colitis. ^{1 2 3 4 5}

Is the combination therapy for ulcerative colitis safe for humans?

Golimumab, used in treating ulcerative colitis, has been evaluated for safety in several studies, showing it is generally safe for humans in real-world settings. ^{2 3 6 7 8}

What makes the combination therapy for ulcerative colitis unique?

This combination therapy for ulcerative colitis is unique because it includes golimumab, a newer anti-TNF (tumor necrosis factor) drug, which is administered through monthly subcutaneous injections and is used when other anti-TNF drugs like infliximab and adalimumab are not effective or tolerated. The inclusion of guselkumab, which targets a different inflammatory pathway, may offer a novel approach by combining mechanisms to better manage the condition. ^{1 2 3 7 9}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with moderate to severe ulcerative colitis who haven't responded well to at least one biologic or similar treatment. Participants must have been diagnosed with UC for a minimum of three months and, if female and able to have children, agree to follow specific contraception guidelines.

Inclusion Criteria

I am following the required birth control measures.

I have been diagnosed with ulcerative colitis for at least 3 months.

I have tried at least one biologic or similar treatment without success or could not tolerate it.

Exclusion Criteria

My inflammation is only in my rectum.

I haven't had cancer, except for non-dangerous skin or treated cervical cancer, in the last 5 years.

I have been diagnosed with a specific type of colitis or Crohn's disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo, guselkumab, golimumab, or JNJ-78934804 subcutaneously. Participants with inadequate response may be escalated to an active treatment.

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of clinical remission and adverse events.

4 weeks

Long-term extension

Participants who are eligible and willing may continue the study intervention they are receiving at Week 44.

Treatment Details

Interventions

• Golimumab
• Guselkumab
• JNJ-78934804
• Placebo

Trial Overview The study tests the effectiveness and safety of JNJ-78934804 against guselkumab and golimumab in patients whose ulcerative colitis hasn't improved with standard advanced therapies. It aims to see which treatment helps more.

Participant Groups

Group I: Group 6: JNJ-78934804 (Low-dose) Experimental Treatment 1 Intervention

Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group II: Group 5: JNJ-78934804 (Mid-dose) Experimental Treatment 1 Intervention

Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group III: Group 4: JNJ-78934804 (High-dose) Experimental Treatment 1 Intervention

Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group IV: Group 3: Golimumab Experimental Treatment 1 Intervention

Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group V: Group 2: Guselkumab Experimental Treatment 1 Intervention

Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group VI: Group 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

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 involving 214 adults with moderately-to-severely active ulcerative colitis, combination therapy with guselkumab and golimumab resulted in a higher clinical response rate at week 12 (83%) compared to golimumab monotherapy (61%) and guselkumab monotherapy (75%).

The safety profile was generally acceptable, with no deaths or serious complications reported during the treatment period, although some adverse events like infections and anemia were noted, indicating the need for monitoring in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Feagan, BG., Sands, BE., Sandborn, WJ., et al.[2023]

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]

References

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

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

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis. [2018]

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

Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance. [2022]

8. 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]

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

Golimumab for the treatment of ulcerative colitis. [2022]