JNJ-77242113 for Ulcerative Colitis

(ANTHEM-UC Trial)

Recruiting at 191 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Fulminant colitis, Toxic megacolon, Stoma, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

252 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-77242113 to see if it can help people with moderately to severely active ulcerative colitis. The medication aims to reduce inflammation in the colon by calming the immune system. Researchers want to find out if it is safe and effective.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the drug JNJ-77242113 for treating ulcerative colitis?

Research on similar drugs like tofacitinib, which is also a Janus kinase inhibitor, shows it can help patients with moderate-to-severe ulcerative colitis achieve remission, meaning their symptoms improve significantly. ^{1 2 3 4 5}

What safety data exists for JNJ-77242113 in humans?

The safety of Janus kinase (JAK) inhibitors, like JNJ-77242113, has been studied in other similar drugs such as tofacitinib and peficitinib, which are used for ulcerative colitis. These studies show that while JAK inhibitors can be effective, they may also have some toxicities, so their safety profile is carefully evaluated in clinical trials. ^{2 4 6 7 8}

How is the drug JNJ-77242113 different from other treatments for ulcerative colitis?

JNJ-77242113 is likely a Janus kinase (JAK) inhibitor, similar to tofacitinib and peficitinib, which are used for ulcerative colitis. These drugs work by blocking specific enzymes involved in the inflammation process, offering a different approach compared to traditional treatments like corticosteroids or anti-TNFα therapies. ^{2 4 6 9 10}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with ulcerative colitis that's been active for at least 12 weeks and hasn't improved with standard treatments. It's not suitable for those whose condition is limited to the rectum or a short section of the colon, have had significant colon surgery, or have other types of bowel diseases.

Inclusion Criteria

My ulcerative colitis is moderate to severe according to the Mayo score.

My condition did not improve with standard treatments, or I couldn't tolerate them.

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

Exclusion Criteria

I have or had severe colitis or toxic megacolon.

I have a stoma.

My ulcerative colitis affects only my rectum or less than 15 cm of my colon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113 or placebo tablets orally from Week 0 through Week 28

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants who achieve clinical response at Week 28 may continue treatment up to Week 76

48 weeks

Treatment Details

Interventions

• JNJ-77242113

Trial Overview The study tests JNJ-77242113 against a placebo to see if it's safer and more effective in treating moderately to severely active ulcerative colitis. Participants will be randomly assigned to receive either the drug or placebo.

Participant Groups

Group I: Group 4: Placebo Experimental Treatment 2 Interventions

Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Group II: Group 3: JNJ-77242113 Dose-3 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Group III: Group 2: JNJ-77242113 Dose-2 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Group IV: Group 1: JNJ-77242113 Dose-1 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.

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 38 patients with moderate-to-severe ulcerative colitis who were resistant to other treatments, 34% achieved steroid-free clinical remission after 48 weeks of treatment with tofacitinib, demonstrating its effectiveness in a challenging patient population.

The study also found that 70% of patients avoided colectomy (surgical removal of the colon) within a year, indicating that tofacitinib can help manage severe cases of ulcerative colitis with an acceptable safety profile, despite some patients experiencing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis. Lair-Mehiri, L., Stefanescu, C., Vaysse, T., et al.[2021]

Tofacitinib is a new oral medication that works by inhibiting Janus kinases, which are important in the inflammation process of ulcerative colitis (UC), and has been approved by the FDA and EMA for treating moderate-to-severe UC.

Clinical trials (Phase II and III) have shown that tofacitinib is effective in inducing and maintaining remission in UC, especially for patients who do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data. Varyani, F., Argyriou, K., Phillips, F., et al.[2023]

Tofacitinib, an oral Janus kinase inhibitor, significantly improved patient-reported outcomes in individuals with active ulcerative colitis, particularly at the 15 mg dose, compared to placebo after 8 weeks of treatment.

Patients who achieved endoscopic remission reported even higher satisfaction and quality of life scores, indicating that tofacitinib not only helps with clinical symptoms but also enhances overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. Panés, J., Su, C., Bushmakin, AG., et al.[2022]

In a Phase 2b trial involving 219 patients with moderate-to-severe ulcerative colitis, peficitinib showed potential efficacy at doses of 75 mg or higher, with improvements in clinical response, remission, and mucosal healing, although a clear dose-response relationship was not established at Week 8.

The safety profile indicated that treatment-emergent adverse events were more common in patients receiving peficitinib compared to placebo, particularly at doses of 75 mg or higher, suggesting a need for careful monitoring at these doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study. Sands, BE., Sandborn, WJ., Feagan, BG., et al.[2022]

Tofacitinib is an oral pan-JAK inhibitor that targets JAK1 and JAK3, which are involved in the inflammatory processes of ulcerative colitis (UC), and was approved by the FDA in 2018 for chronic treatment of the disease.

The review highlights the efficacy and safety of tofacitinib, suggesting it can effectively reduce symptoms and the frequency of exacerbations in patients with UC, addressing a significant challenge in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib, the First Oral Janus Kinase Inhibitor Approved for Adult Ulcerative Colitis. Palasik, BN., Wang, H.[2021]

TD-1473 is a gut-selective pan-JAK inhibitor that showed potent activity in preclinical studies and was well tolerated in a Phase 1b clinical trial involving patients with moderately to severely active ulcerative colitis (UC).

The treatment resulted in high concentrations of the drug in colonic tissue with low plasma exposure, leading to trends of reduced disease activity in UC patients, indicating its potential efficacy while minimizing systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. Sandborn, WJ., Nguyen, DD., Beattie, DT., et al.[2021]

In a study of 58 patients with moderate-to-severe inflammatory bowel disease (IBD) who were resistant to anti-TNF therapy, tofacitinib led to a clinical response in 69% of patients, demonstrating its efficacy as a treatment option.

By 12 months of treatment, 27% of patients achieved clinical, steroid-free remission, indicating that tofacitinib can provide significant long-term benefits for patients with difficult-to-treat IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience with Tofacitinib in IBD at a Tertiary Center. Weisshof, R., Aharoni Golan, M., Sossenheimer, PH., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis. [2021]

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

Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data. [2023]

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

Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. [2022]

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

Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia. [2022]

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

Tofacitinib, the First Oral Janus Kinase Inhibitor Approved for Adult Ulcerative Colitis. [2021]

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

Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. [2021]

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

Colonic vitamin D receptor expression is inversely associated with disease activity and jumonji domain-containing 3 in active ulcerative colitis. [2022]

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

Real-World Experience with Tofacitinib in IBD at a Tertiary Center. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tofacitinib for ulcerative colitis: two-year results of the ICC Registry. [2023]