What side effects are associated with this type of intervention?

The most common treatments for Ulcerative Colitis include biologic agents, immunomodulators, and 5-aminosalicylates (5-ASA). Biologic agents, such as anti-TNF agents (e.g., infliximab, adalimumab), can cause side effects like infections, infusion reactions, and potential development of antibodies against the drug. Immunomodulators (e.g., azathioprine, methotrexate) may lead to bone marrow suppression, liver toxicity, and increased risk of infections. 5-ASA drugs (e.g., mesalamine) are generally well-tolerated but can cause headaches, nausea, and rarely, kidney issues. Glucocorticoids, used for short-term flare control, can result in weight gain, hypertension, and osteoporosis with long-term use.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of moderate to severe Ulcerative Colitis. These include anti-TNF agents such as infliximab (Remicade) and adalimumab (Humira), which target tumor necrosis factor-alpha to reduce inflammation. Vedolizumab (Entyvio), an integrin receptor antagonist, and ustekinumab (Stelara), an interleukin-12 and interleukin-23 antagonist, are also approved for UC. These biologics work by modulating the immune response to decrease inflammation and maintain remission in patients with UC.

What other types of research exist?

Promising novel alternatives to biologic agents for ulcerative colitis patients include Janus kinase (JAK) inhibitors like tofacitinib, sphingosine-1-phosphate (S1P) receptor modulators such as ozanimod, and novel oral agents like NX-13, which is currently in Phase 2 trials. These therapies offer different mechanisms of action compared to traditional biologics and have shown potential in clinical studies.

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Oral NX-13 for Ulcerative Colitis

Phase 2

Waitlist Available

Led By Fabio Catalidi, MD

Research Sponsored by Landos Biopharma Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Summary

This trial is testing a new treatment for people with moderate to severe ulcerative colitis. The goal is to see if this treatment can reduce inflammation and improve symptoms. The study includes a period to monitor the effects over time.

Who is the study for?

This trial is for adults aged 18-75 with moderate to severe ulcerative colitis diagnosed at least 90 days prior. Participants must have a Mayo Score of ≥5 indicating active disease. Not eligible are those with fulminant colitis, toxic megacolon, Crohn's disease, infections, or conditions likely requiring hospitalization or surgery within 12 weeks.

What is being tested?

The study tests two doses of NX-13 (250mg and 750mg) against a placebo in people with ulcerative colitis. It's a Phase 2 trial that includes an initial treatment phase followed by long-term extension to assess the drug's effectiveness and safety over time.

What are the potential side effects?

While specific side effects for NX-13 aren't listed here, common side effects for new ulcerative colitis treatments can include gastrointestinal discomfort, headache, fatigue, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To assess the clinical activity of oral NX-13 vs placebo

Secondary study objectives

Safety and Tolerability-AE/SAE - Chemistry

Safety and Tolerability-AE/SAE - Hematology

Safety and Tolerability-AE/SAE - Vital Signs

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NX-13 750mgExperimental Treatment1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Group II: NX-13 250mgExperimental Treatment1 Intervention

Group III: NX-13 PlaceboPlacebo Group1 Intervention

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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

Biologic agents, such as infliximab and adalimumab, are monoclonal antibodies that target and neutralize tumor necrosis factor-alpha (TNF-alpha), a cytokine involved in systemic inflammation. By inhibiting TNF-alpha, these agents reduce inflammation and help achieve and maintain remission in UC patients. Immunomodulators like azathioprine and 6-mercaptopurine work by altering the immune response, reducing the activity of the immune system to prevent it from attacking the colon. These treatments are crucial for UC patients as they help control chronic inflammation, reduce symptoms, and prevent disease progression, thereby improving the quality of life.