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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.
Select...
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.
Select...
I have had abnormal growths in my colon that were not fully removed.
Select...
I have had surgery to remove parts of my small intestine or more than two parts of my colon.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

Prometheus Biosciences, Inc.Lead Sponsor
5 Previous Clinical Trials
544 Total Patients Enrolled
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
5 Previous Clinical Trials
544 Total Patients Enrolled
Prometheus BiosciencesStudy DirectorClinicaltrials Call Center
3 Previous Clinical Trials
379 Total Patients Enrolled

Media Library

PRA023 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05013905 — Phase 2
Crohn's Disease Research Study Groups: PRA023
Crohn's Disease Clinical Trial 2023: PRA023 Highlights & Side Effects. Trial Name: NCT05013905 — Phase 2
PRA023 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013905 — Phase 2
~13 spots leftby Oct 2025
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