Combination Therapy for Crohn's Disease

(DUET-CD Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for Crohn's disease, which causes inflammation in the digestive tract. Researchers aim to determine if a new drug, JNJ-78934804, outperforms two current treatments, guselkumab and golimumab, both immunotherapies, after 48 weeks. Participants will be assigned to different groups to receive low, mid, or high doses of JNJ-78934804, one of the other drugs, or a placebo. This trial suits individuals with moderate to severe Crohn's disease for at least three months who have not responded well to other biologic treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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

Research has shown that golimumab, a medication for rheumatoid arthritis and ulcerative colitis, carries serious risks. It may cause infections requiring hospital treatment or could even be life-threatening. However, the FDA has approved it, indicating that its benefits outweigh these risks for certain conditions.

For guselkumab, studies in Crohn's disease suggest it is generally safe. Some individuals might experience allergic reactions or infections, but long-term research has shown it has few side effects overall.

Researchers are still studying JNJ-78934804 to determine its safety and effectiveness. As it is in the early stages of study, less information is available about its safety compared to the other two treatments. This trial aims to gather more data on its safety.

In summary, while golimumab and guselkumab have known risks, they are generally considered safe for use in other conditions. JNJ-78934804 is newer, and more research is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Crohn's disease because they offer new ways to manage the condition. Golimumab and Guselkumab are known for targeting specific proteins involved in inflammation, potentially offering more precise control compared to traditional options like corticosteroids or other biologics. JNJ-78934804 is particularly intriguing, as it comes in different doses and might provide a tailored approach to treatment, enhancing effectiveness or reducing side effects. These therapies might offer hope for quicker relief and better long-term outcomes for those who haven't responded well to existing treatments.

What evidence suggests that this trial's treatments could be effective for Crohn's Disease?

Studies have shown that golimumab, one of the treatments in this trial, effectively treats Crohn's disease, with many patients responding well at both 12 weeks (78%) and 52 weeks (81%). Another treatment option, guselkumab, has also produced positive outcomes, with over 85% of patients achieving clinical remission at 96 weeks in some studies. Initial research on JNJ-78934804, tested in various doses in this trial, is more limited. However, when combined with treatments like guselkumab and golimumab in related conditions, it showed a clinical remission rate of 47.9%. While these treatments show promise, more research is needed to confirm the benefits of JNJ-78934804 specifically for Crohn's disease. ^{3 6 7 8 9}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30353751/

Clinical effectiveness of golimumab in Crohn's disease Despite this, more than one-third of the patients appeared to have had clinical benefit after a median follow-up of more than 1.5 years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12525101/

Real-World Effectiveness and Safety of Golimumab in ... Background/Objectives: Golimumab has proven efficacy in inducing and maintaining remission in moderate-to-severe ulcerative colitis (UC).

3. academic.oup.com academic.oup.com/ecco-jcc/article/12/4/458/4775067

Golimumab Therapy for Anti-Tumour Necrosis Factor ... Clinical response at 3 months was achieved in 35/45 [77.7%] patients. The cumulative probabilities that patients with an initial response ...

4. es.aetna.com es.aetna.com/cpb/medical/data/700_799/0790.html

Golimumab (Simponi and Simponi Aria) The authors concluded that based on the results of the studies included in this review, GLM appeared to be more effective than placebo in patients with RA, PsA, ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/00365521.2018.1519597

Clinical effectiveness of golimumab in Crohn's disease High clinical response rates were observed at both 12 weeks (78%) and 52 weeks (81%), but interpretation of the results was complicated because ...

6. simponi.com simponi.com/

SIMPONI® (golimumab) Treatment® SIMPONI® (golimumab) is for RA, PsA, AS and UC treatment. See full Prescribing & Safety info including Boxed Warning.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf

Simponi Aria - accessdata.fda.gov The safety data described below are based on one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/golimumab-intravenous-route-subcutaneous-route/description/drg-20073012

Golimumab (intravenous route, subcutaneous route) Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated pediatric-specific problems that ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf

Simponi - accessdata.fda.gov Nearly all of the reported TNF blocker associated cases have occurred in patients with Crohn's disease or ulcerative colitis. The majority were in adolescent ...