What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include mesalamine, glucocorticoids, and biologic agents. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for short-term induction therapy, may lead to systemic side effects like adrenal suppression, osteoporosis, and increased infection risk if used long-term. Biologic agents, while effective, can increase the risk of infections and may cause infusion reactions, headache, and abdominal pain. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Ulcerative Colitis, including biologics like infliximab, adalimumab, and vedolizumab, which target specific components of the immune system to reduce inflammation. Immunomodulators such as azathioprine and 6-mercaptopurine are also used to suppress the immune response. Additionally, 5-aminosalicylates (5-ASA) like mesalamine are commonly prescribed to reduce inflammation in the colon. These treatments aim to induce and maintain remission in patients with UC.

What other types of research exist?

Promising novel alternatives to PRA023 for Ulcerative Colitis patients in 2024 include anti-IL-23 agents (e.g., risankizumab), JAK-inhibitors, anti-integrins (e.g., vedolizumab), and S1P modulators. These therapies are in advanced stages of clinical trials or have been recently approved and have shown efficacy and safety in treating UC.

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Monoclonal Antibodies

PRA023 for Ulcerative Colitis (ARTEMIS-UC Trial)

Phase 2

Waitlist Available

Research Sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of ulcerative colitis (UC)

Moderately to severely active UC as defined by 3-component Modified Mayo score

Must not have

Current or impending need for colostomy or ileostomy

Current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~14 weeks

Summary

This trial is testing a new medication called PRA023 to help people with severe Ulcerative Colitis. The goal is to see if it can reduce inflammation and heal the digestive tract. Participants will be monitored for safety and effectiveness over several months.

Who is the study for?

This trial is for people with moderate to severe Ulcerative Colitis who haven't responded well to, or can't tolerate, certain UC treatments like steroids or immunosuppressants. Participants must have a confirmed diagnosis and be able to follow the study's procedures. Those with Crohn's disease, at high risk per investigator's opinion, or unable/unwilling to use effective contraception are excluded.

What is being tested?

The trial is testing PRA023 in two ways: directly through IV administration and by assessing its safety and effectiveness in those who test positive on companion diagnostic tests. After an initial 12-week period, participants can choose to continue treatment for another 38 weeks.

What are the potential side effects?

While specific side effects of PRA023 aren't listed here, common ones for similar drugs include infusion reactions (like pain or discomfort at the injection site), gastrointestinal symptoms (nausea, diarrhea), potential liver issues, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ulcerative colitis.

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My ulcerative colitis is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need or will soon need a surgery for a colostomy or ileostomy.

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I currently have severe colon issues, including inflammation or surgery.

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I am using two effective birth control methods during and up to 12 weeks after the study.

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I have had or currently have untreated low or high-grade abnormal growths in my colon.

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I have been diagnosed with Crohn's disease or indeterminate colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Discontinued Due to an AE

Percentage of Participants Who Experienced an Adverse Event (AE)

Percentage of Participants Who Had One or More Serious Adverse Events

+1 more

Secondary study objectives

Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response

Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission

Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2 TulisokibartExperimental Treatment2 Interventions

Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Group II: Cohort 1 TulisokibartExperimental Treatment1 Intervention

Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Group III: Cohort 2 PlaceboPlacebo Group2 Interventions

Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Group IV: Cohort 1 PlaceboPlacebo Group1 Intervention

Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include aminosalicylates, corticosteroids, immunomodulators, and biologics. Aminosalicylates, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the immune response to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune system's activity to prevent ongoing inflammation. Biologics, including anti-TNF agents like infliximab, target specific proteins involved in the inflammatory process. These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and improve quality of life by controlling the underlying inflammation.

Emerging Therapies for Inflammatory Bowel Diseases.Novel topical therapies for distal colitis.