What is the mechanism of action of this treatment?

Common treatments for Crohn's Disease include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab) and anti-TL1A monoclonal antibodies like PRA023. Anti-TNF agents work by inhibiting tumor necrosis factor-alpha (TNF-alpha), a cytokine that promotes inflammation, thereby reducing the inflammatory response in the gastrointestinal tract. Anti-TL1A monoclonal antibodies target TL1A, another cytokine involved in inflammation, aiming to reduce immune system overactivity. These treatments are crucial for Crohn's Disease patients as they help manage symptoms, induce and maintain remission, and improve quality of life by controlling the underlying inflammation that characterizes the disease.

What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as ustekinumab and anti-TNF agents, often have side effects including increased risk of infections, nasopharyngitis, and injection site reactions. Ustekinumab, specifically, has low immunogenicity but can still cause infections and nasopharyngitis. Anti-TNF agents may lead to the formation of antidrug antibodies, which can reduce their efficacy. Other potential side effects of monoclonal antibodies include headache, fatigue, and gastrointestinal symptoms. It is important to monitor for these adverse effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

Several biologic agents have been FDA-approved for the treatment of Crohn's Disease. These include TNF-alpha inhibitors like infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia), which help reduce inflammation by targeting tumor necrosis factor-alpha. Another class includes integrin inhibitors like vedolizumab (Entyvio), which is a gut-selective antibody. Ustekinumab (Stelara), an IL-12/23 inhibitor, is also approved for patients who have not responded to other treatments. These biologics have shown efficacy in inducing and maintaining remission in patients with moderate to severe Crohn's Disease.

What other types of research exist?

Promising novel alternatives to PRA023 for Crohn's Disease include certolizumab pegol, a pegylated humanized Fab' fragment targeting TNF-alpha, and risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit. Both have shown efficacy in clinical trials for moderate-to-severe Crohn's Disease.

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Monoclonal Antibodies

PRA023 for Crohn's Disease (APOLLO-CD Trial)

Phase 2

Waitlist Available

Research Sponsored by Prometheus Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy

Confirmed diagnosis of Crohn's disease

Must not have

Current stoma or need for colostomy or ileostomy

Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called PRA023 for people with moderately to severely active Crohn's Disease. The medication aims to reduce inflammation in the digestive tract, which should help relieve symptoms like pain and diarrhea. Participants will initially take the medication for a few months and may choose to continue for several more months.

Who is the study for?

This trial is for adults with Crohn's Disease who have not responded well to standard treatments like corticosteroids or immunosuppressants. Participants should be able to follow the study procedures and use two forms of contraception if they can have children. People with recent bowel surgery, extensive resections, high risk as per investigator's opinion, certain lab criteria, or specific types of colitis are excluded.

What is being tested?

The trial tests PRA023 IV, a new drug for Crohn's Disease. It includes a 12-week induction phase followed by an optional 38-week extension. The goal is to see how safe and effective PRA023 is in managing moderate to severe symptoms compared to previous therapies.

What are the potential side effects?

While the specific side effects of PRA023 are not listed here, similar drugs often cause immune system reactions, infusion-related discomforts, potential infections due to lowered immunity, gastrointestinal issues and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My Crohn's disease is moderate to severe, confirmed by tests.

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I have been diagnosed with Crohn's disease.

Exclusion Criteria

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

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I have or need a stoma for waste removal.

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

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I might have an abscess in my abdomen or near my anus.

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My Crohn's disease affects only my stomach and upper small intestine.

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I have been diagnosed with ulcerative colitis or indeterminate colitis.

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I have had abnormal growths in my colon that were not fully removed.

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I have had surgery to remove parts of my small intestine or more than two parts of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Adverse Events Leading to Discontinuation

Endoscopic Improvement

+1 more

Secondary study objectives

Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)

Clinical Remission

Clinical Response

+8 more

Other study objectives

Endoscopic Improvement and clinical remission by companion diagnostic (CDx) status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRA023Experimental Treatment2 Interventions

Participants to receive PRA023 administered by intravenous (IV) infusion.

0 / 9Eligibility 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 Crohn's Disease include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab) and anti-TL1A monoclonal antibodies like PRA023. Anti-TNF agents work by inhibiting tumor necrosis factor-alpha (TNF-alpha), a cytokine that promotes inflammation, thereby reducing the inflammatory response in the gastrointestinal tract. Anti-TL1A monoclonal antibodies target TL1A, another cytokine involved in inflammation, aiming to reduce immune system overactivity. These treatments are crucial for Crohn's Disease patients as they help manage symptoms, induce and maintain remission, and improve quality of life by controlling the underlying inflammation that characterizes the disease.