Dupilumab for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+132 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Disqualifiers: Severe colitis, Ileal pouch, Crohn's, others

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have an inadequate response or intolerance to certain treatments like oral corticosteroids, 5-aminosalicylic acid compounds, or immunomodulators, which might imply some changes to your current medication regimen.

What data supports the effectiveness of the drug Dupilumab for treating ulcerative colitis?

Dupilumab has been shown to be effective in treating other inflammatory conditions like severe asthma and chronic rhinosinusitis with nasal polyps by blocking certain proteins (IL-4 and IL-13) that cause inflammation. This suggests it might also help with ulcerative colitis, which is another inflammatory condition.

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How is the drug Dupilumab unique for treating ulcerative colitis?

Dupilumab is unique because it is a monoclonal antibody that targets and blocks the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in type 2 inflammatory diseases. This mechanism is different from traditional treatments for ulcerative colitis, which often focus on suppressing the immune system more broadly.

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Eligibility Criteria

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.

Inclusion Criteria

My UC hasn't improved with standard treatments or I can't tolerate them.

My screening shows specific markers that the trial targets.

Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment

Exclusion Criteria

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

I've had colitis for over 8 years or left-sided colon disease for more than 10 years and had a recent colonoscopy.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 to 4 weeks

Treatment

52-week investigational medicinal product (IMP) intervention with dupilumab or matching placebo

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension (optional)

Administration of open-label dupilumab therapy for study participants who qualify

Participant Groups

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.

Group I: Open-label arm (optional) Experimental Treatment 1 Intervention

Regular administration of open label dupilumab

Group II: Dupilumab Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Dupilumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

🇪🇺 Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Gastroenterology Consultants PC-Site Number:8400022 Roswell, GA

Tyler Research Institute-Site Number:8400031 Tyler, TX

Advanced Research Institute, Inc.-Site Number:8400026 New Port Richey, FL

Javara Research-Site Number:8400008 Charlotte, NC

More Trial Locations

Who Is Running the Clinical Trial?

Sanofi Lead Sponsor

Regeneron Pharmaceuticals Industry Sponsor

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Dupilumab's Impact on Blood Parameters in Nasal Polyposis: 18-Month Follow-Up in Real Life. [2023] Dupilumab represents the first approved biological for severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP).

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan. [2021] Dupilumab, which blocks the shared receptor component for interleukin-4 and interleukin-13, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-52 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers.

3. England pubmed.ncbi.nlm.nih.gov

Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. [2022] Dupilumab is the first monoclonal antibody therapy to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The goal of the study was to assess its effectiveness and efficacy in a real-world setting. This study aims to assess how clinical outcomes of biologic therapy in real-world application (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness gap.

4. Italy pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. [2022] Dupilumab is a humanized monoclonal antibody targeting the IL4/IL13 signaling pathway, already used for atopic dermatitis and chronic rhinitis with nasal polyps, recently approved for severe type-2 asthma. Its efficacy has been demonstrated in randomized control trials. The aim of our study is to evaluate possible early clinical improvement and type 2 biomarkers modifications in severe asthmatic patients treated with dupilumab in a real-life setting.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Chronic Rhinosinusitis with Nasal Polyps. [2022] Dupilumab (Dupixent®) is a fully human IgG4 monoclonal antibody against the interleukin (IL)-4 receptor α (IL-4Rα) subunit, which is shared by the type I IL-4 and the type II IL-4/IL-13 receptor complexes. By binding to and blocking this subunit, dupilumab inhibits IL-4 and IL-13, which are the major drivers of human type 2 inflammatory disease [e.g. asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyps (CRSwNP)]. Dupilumab, administered subcutaneously, is the first biological therapy to be approved for the treatment of adults with inadequately controlled CRSwNP in the EU and the USA. In two placebo-controlled, multinational, phase III studies of 24 and 52 weeks' duration, the addition of dupilumab (300 mg every 2 weeks) to the intranasal corticosteroid treatment of adults with severe, inadequately controlled CRSwNP was generally well tolerated and improved nasal polyp size, sinus opacification and health-related quality of life (HR-QOL), relieved the major symptoms of CRSwNP (nasal congestion or obstruction, nasal discharge and loss of smell) and reduced the use of systemic corticosteroids and the need for nasal polyp surgery. Improvements in nasal polyp size, sinus opacification and nasal congestion or obstruction were achieved regardless of the presence of comorbid asthma or NSAID-exacerbated respiratory disease, or a history of previous nasal polyp surgery, with patients with comorbid asthma also demonstrating improvements in lung function and asthma control regardless of their baseline eosinophil count. Thus, add-on subcutaneous dupilumab is a valuable treatment option for adults with inadequately controlled CRSwNP.

6. Italy pubmed.ncbi.nlm.nih.gov

Higher rates of COVID-19 but less severe infections reported for patients on Dupilumab: a Big Data analysis of the World Health Organization VigiBase. [2022] Dupilumab (Dupixent®) is a monoclonal antibody that inhibits IL-4 and IL-13 signaling used for the treatment of allergic diseases. Whilst biologic therapy is traditionally regarded as immunosuppressive and capable to increase the infectious risk, Dupilumab does not display these characteristics and may be even protective in certain cases. We investigated the link between Dupilumab therapy and SARS-CoV-2 infection.

7. United States pubmed.ncbi.nlm.nih.gov

Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease. [2023] Dupilumab is a novel anti-IL-4 receptor-α mAb that targets the signaling pathways of IL-4 and IL-13. Thus far, the data about adequate humoral immune response after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients who are taking dupilumab have been limited.