Combination Therapy for Crohn's Disease

(DUET-CD Trial)

Recruiting at 604 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: Biologics

Disqualifiers: Surgery, Abscess, Malignancy, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

703 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-78934804 to see if it works better than two existing treatments for autoimmune conditions. The study will compare their effectiveness over several months.

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.

Is Golimumab safe for treating Crohn's Disease?

Golimumab has been used in patients with Crohn's Disease and ulcerative colitis, showing some safety in humans, but its effectiveness can vary, and close monitoring is recommended. In some cases, patients needed higher doses to maintain the treatment's effect. ^{1 2 3 4 5}

How is the combination therapy for Crohn's disease with Golimumab, Guselkumab, and JNJ-78934804 different from other treatments?

This combination therapy is unique because it involves Golimumab, which is typically used for ulcerative colitis and not standard for Crohn's disease, and Guselkumab, which targets a different inflammatory pathway (interleukin-23) than traditional treatments. This approach may offer a novel option for patients who do not respond to standard anti-TNF (tumor necrosis factor) therapies. ^{1 2 5 6 7}

What data supports the effectiveness of the drug combination therapy for Crohn's Disease?

Golimumab, one of the drugs in the combination, has been used off-label for difficult-to-treat Crohn's Disease cases, showing potential as a rescue medication. Additionally, adalimumab, a similar drug targeting tumor necrosis factor, has been effective in inducing and maintaining remission in Crohn's Disease patients, suggesting that similar drugs may also be beneficial. ^{1 5 6 8 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 Crohn's Disease who haven't had success with at least one biologic treatment. They must have been diagnosed at least 3 months prior and meet specific disease activity criteria. Women of childbearing age should comply with contraception requirements. Exclusions include a recent history of cancer, certain infections, or recent surgeries.

Inclusion Criteria

I have Crohn's disease and did not respond well to at least one biologic treatment.

I have been diagnosed with Crohn's disease for at least 3 months.

I have a confirmed diagnosis of moderate to severe Crohn's disease.

Exclusion Criteria

I have or might have an abscess, but if it was drained and treated properly, I can still participate.

I have not had major surgery or bowel resection in the past 6 months.

I have a history of or currently have a chronic infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension (optional)

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

Long-term

Treatment Details

Interventions

• Golimumab
• Guselkumab
• JNJ-78934804
• Placebo

Trial Overview The study tests the effectiveness of JNJ-78934804 against guselkumab and golimumab in treating Crohn's Disease by week 48. Participants will receive either the experimental drug (JNJ-78934804) or one of the known drugs along with a placebo to compare results.

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+

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

Findings from Research

In a 52-week study involving 24 patients with Crohn's disease who previously lost response to infliximab, adalimumab demonstrated significant efficacy, with clinical remission rates increasing from 35% at baseline to 58% at week 52.

Adalimumab was well tolerated, with no patients experiencing intolerance and no serious toxicities reported, indicating it is a safe option for maintaining remission in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. Peyrin-Biroulet, L., Laclotte, C., Bigard, MA.[2015]

Adalimumab, a monoclonal antibody targeting tumor necrosis factor, has been shown to effectively induce clinical response and remission in patients with moderate-to-severe Crohn's disease, based on recent evaluations.

The safety profile of adalimumab appears comparable to other similar treatments, but further long-term studies are necessary to fully assess its efficacy and safety in Crohn's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab for the treatment of Crohn's disease. Papadakis, KA.[2010]

In a retrospective audit of 61 patients with Crohn's disease, adalimumab achieved remission in 57% of patients and maintained an ongoing response rate of 83.6% over an average follow-up of 8 months, indicating its efficacy in real-life settings.

Adverse effects were reported in 23% of patients, with infections being the most common, but only two patients discontinued treatment due to these adverse events, suggesting a generally acceptable safety profile for adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey on the use of adalimumab as maintenance therapy in Crohn's disease in England and Ireland. Russo, EA., Iacucci, M., Lindsay, JO., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. [2015]

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

Adalimumab for the treatment of Crohn's disease. [2010]

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

Survey on the use of adalimumab as maintenance therapy in Crohn's disease in England and Ireland. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Golimumab as Third- or Fourth-Line Anti-TNF Therapy in Patients with Refractory Crohn's Disease: A Case Series. [2022]

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

Golimumab Therapy in Six Patients With Severe Pediatric Onset Crohn Disease. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adalimumab for the Crohn's disease: a systematic review and meta-analysis of published randomized placebo-controlled trials. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease. [2021]