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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

APOLLO-CD Trial Summary

This trial is testing a new drug for Crohn's Disease to see if it is safe and effective. Participants will take the drug for 12 weeks and then can choose to continue taking it for an additional 38 weeks.

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.Check my eligibility

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.See study design

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.

APOLLO-CD Trial 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.

APOLLO-CD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Adverse Events Leading to Discontinuation

Endoscopic Improvement

+1 more

Secondary outcome measures

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

Clinical Remission

Clinical Response

+8 more

Other outcome measures

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

APOLLO-CD Trial Design

1Treatment groups

Experimental Treatment

Group I: PRA023Experimental Treatment2 Interventions

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

0 / 2Eligibility 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.