What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis that are similar to Dupilumab include Vedolizumab, Adalimumab, and Golimumab. Vedolizumab can cause headaches, joint pain, fever, and increased risk of infections. Adalimumab's side effects include injection site reactions, upper respiratory infections, and increased risk of serious infections. Golimumab may lead to upper respiratory infections, injection site reactions, and increased risk of serious infections. All these treatments share a risk of immunosuppression, which can lead to increased susceptibility to infections.

What prior FDA approvals exist?

Several monoclonal antibodies have been approved by the FDA for the treatment of Ulcerative Colitis. These include infliximab (Remicade), adalimumab (Humira), and golimumab (Simponi), which are anti-TNF agents that inhibit tumor necrosis factor-alpha. Vedolizumab (Entyvio) is another monoclonal antibody that targets the integrin α4β7, reducing gut inflammation. Ustekinumab (Stelara), which targets IL-12 and IL-23, has also been approved for UC. These treatments, like dupilumab, aim to modulate the immune response to reduce inflammation and manage symptoms of UC.

What other types of research exist?

Promising novel alternatives to Dupilumab for Ulcerative Colitis patients include: 1) Ustekinumab, a monoclonal antibody targeting IL-12 and IL-23, which has shown efficacy in inducing and maintaining remission in UC. 2) Vedolizumab, an integrin receptor antagonist that inhibits the migration of T-lymphocytes into the gut tissue, effective for both induction and maintenance of remission. 3) Tofacitinib, an oral Janus kinase (JAK) inhibitor, which has demonstrated effectiveness in moderate to severe UC. These alternatives offer different mechanisms of action and have been supported by clinical trial data.

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Monoclonal Antibodies

Dupilumab for Ulcerative Colitis

Q: What is the mechanism of action of this treatment?

Monoclonal antibodies, such as Dupilumab, target specific cytokines involved in the inflammatory process of Ulcerative Colitis. Dupilumab inhibits IL-4 and IL-13 signaling, which are key drivers of the Th2 immune response, reducing inflammation and tissue damage in the colon. This mechanism is crucial for UC patients as it directly addresses the underlying immune dysregulation, potentially leading to better disease control and improved quality of life. Other common treatments, like anti-TNF agents (e.g., infliximab) and anti-integrin therapies (e.g., vedolizumab), also work by targeting specific components of the immune system to reduce inflammation and promote mucosal healing.

Verified Trial

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Participants must be ≥18 years of age at the time of signing the informed consent

Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy

Must not have

Severe extensive colitis as evidenced by: Current hospitalization, Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit, UC limited to the rectum only or to <20 cm of the colon

Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, week 24 and week 52

Summary

This trial tests dupilumab, a medication that reduces inflammation, in people with moderate to severe Ulcerative Colitis who have a specific type of immune response. The goal is to see if it can help reduce their symptoms by blocking proteins that cause inflammation.

Who is the study for?

Adults aged 18+ with moderately to severely active Ulcerative Colitis and an eosinophilic phenotype can join. They must have certain symptoms scored by the Mayo score, not responded well to standard treatments like biologics or corticosteroids, and cannot be planning surgery for UC complications.

What is being tested?

The trial is testing Dupilumab against a placebo in a double-blind setup where neither participants nor researchers know who's getting what. It aims to see if Dupilumab is effective and safe over a year of treatment followed by a 12-week observation.

What are the potential side effects?

While specific side effects are not listed here, Dupilumab could potentially cause reactions at the injection site, allergic reactions, eye problems or inflammation in various organs similar to other drugs that modulate the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My ulcerative colitis is moderate to severe, based on a specific score.

Exclusion Criteria

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

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I am hospitalized with severe colitis and might need surgery soon.

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I have or have had an ileal pouch, ostomy, stoma, or fistula.

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I needed surgery for serious stomach or gut issues in the last 2 months.

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I have a history of eosinophilic colitis.

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I have severe abdominal issues, including an abscess or extremely swollen colon.

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I have a blockage in my intestines confirmed by imaging or endoscopy.

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I have had a major part of my colon removed.

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I have had or currently have abnormal growths in my colon that haven't been removed.

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I have been diagnosed with a specific type of colitis or have symptoms that may suggest Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, week 24 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, week 24 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of participants who are in clinical remission at Week 24

Secondary study objectives

Change from baseline (Screening visit) in the normalized enrichment scores (NES) in type 2 inflammation transcriptome signature at Week 24 and Week 52.

Change from baseline in abdominal pain assessed by Abdominal Pain Numerical Rating Scale (NRS) at Week 8, Week 24, and Week 52

Change from baseline in the partial Mayo score at Week 8, Week 24, and Week 52

+11 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

Initial loading dose followed by regular administration for the duration of the treatment period.

Group II: PlaceboPlacebo Group1 Intervention

Initial loading dose followed by regular administration for the duration of the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 11Eligibility 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

Monoclonal antibodies, such as Dupilumab, target specific cytokines involved in the inflammatory process of Ulcerative Colitis. Dupilumab inhibits IL-4 and IL-13 signaling, which are key drivers of the Th2 immune response, reducing inflammation and tissue damage in the colon. This mechanism is crucial for UC patients as it directly addresses the underlying immune dysregulation, potentially leading to better disease control and improved quality of life. Other common treatments, like anti-TNF agents (e.g., infliximab) and anti-integrin therapies (e.g., vedolizumab), also work by targeting specific components of the immune system to reduce inflammation and promote mucosal healing.

Emerging Therapies for Inflammatory Bowel Diseases.