JNJ-77242113 for Ulcerative Colitis

(ANTHEM-UC Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new medicine, JNJ-77242113, for people with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. Participants will receive different doses of the medicine or a placebo (a pill with no active ingredient) to determine which works best. The trial seeks individuals who have had moderately to severely active ulcerative colitis for at least 12 weeks and have not responded well to other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that JNJ-77242113 appears safe for people with ulcerative colitis. Earlier studies found that participants generally tolerated the treatment well, demonstrating a good balance of effectiveness and safety. The available data reported no major safety issues or severe side effects. Although JNJ-77242113 is still under investigation, these early findings suggest it could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which usually involve anti-inflammatory drugs or immunosuppressants, JNJ-77242113 offers a new approach. Researchers are excited about JNJ-77242113 because it potentially targets inflammation in a more precise manner, which could lead to fewer side effects and better outcomes for patients. Additionally, the different dosing options, including Dose-1, Dose-2, and Dose-3, allow for flexibility in managing the condition based on individual patient needs. These features could make JNJ-77242113 a promising alternative to existing therapies.

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

Research has shown that JNJ-77242113, also known as icotrokinra, may help treat ulcerative colitis. In earlier studies, 63.5% of patients taking a 400 mg dose once a day experienced symptom improvement after 12 weeks, compared to 27% of those who took a placebo (a pill with no active medicine). By Week 28, 31.7% of patients continued to see meaningful benefits. In this trial, participants will be assigned to different groups receiving varying doses of JNJ-77242113 or a placebo to further evaluate its effectiveness in reducing symptoms for people with moderately to severely active ulcerative colitis. ^{1 2 3 4 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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

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]

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 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]

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 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, 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 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]

Citations

1. jnj.com jnj.com/media-center/press-releases/icotrokinra-maintains-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-through-28-weeks-in-ulcerative-colitis

Icotrokinra maintains standout combination of therapeutic ... Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical ...

2. jnj.com jnj.com/media-center/press-releases/icotrokinra-data-in-ulcerative-colitis-show-potential-for-a-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill

Icotrokinra data in ulcerative colitis show potential for a ... At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06049017

NCT06049017 | A Study of JNJ-77242113 in Participants ... The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ...

4. prnewswire.com prnewswire.com/news-releases/icotrokinra-data-in-ulcerative-colitis-show-potential-for-a-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-302576329.html

Icotrokinra data in ulcerative colitis show potential for a ... At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), ...

5. hcplive.com hcplive.com/view/anthem-uc-icotrokinra-jnj-2113-shows-promise-ulcerative-colitis

ANTHEM-UC: Icotrokinra (JNJ-2113) Shows Promise for ... Topline results from ANTHEM-UC study showed all 3 doses of once-daily icotrokinra met the primary endpoint of clinical response at week 12.

6. isrctn.com isrctn.com/pdf/15936332

Phase 2b efficacy and safety study of JNJ-77242113 in ... The aim of this study is to learn about the effectiveness and safety of JNJ-77242113 for treatment of ulcerative colitis compared to placebo ( ...