Dupilumab for Ulcerative Colitis

Recruiting at 150 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dupilumab, a monoclonal antibody, can effectively and safely aid individuals with moderate to severe ulcerative colitis, particularly those with a high eosinophil count. Participants will receive either the drug or a placebo for 52 weeks, with an option for an open-label phase where everyone receives the actual drug. Ideal candidates have tried standard treatments like oral steroids or 5-ASA without success and experience frequent symptoms such as rectal bleeding and increased stool frequency. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dupilumab is generally safe. It has treated conditions like moderate-to-severe atopic dermatitis and eosinophilic esophagitis. In these studies, most participants experienced only mild or moderate side effects.

Common side effects include injection site reactions, such as redness or swelling, and mild eye issues like dryness or irritation. Serious side effects were rare. The FDA has approved dupilumab for several conditions, indicating its safety. However, since this trial focuses on ulcerative colitis, the body might react differently. Prospective participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dupilumab for ulcerative colitis because it offers a novel approach compared to standard treatments like aminosalicylates, corticosteroids, and immunosuppressants. Unlike these traditional therapies, which primarily aim to reduce inflammation broadly, dupilumab specifically targets and blocks the activity of certain proteins involved in the inflammatory process, such as interleukin-4 and interleukin-13. This targeted action can potentially reduce inflammation more effectively and with fewer side effects. Additionally, dupilumab is already being used successfully to treat other inflammatory conditions like eczema and asthma, which adds to the optimism about its potential benefits for ulcerative colitis.

What evidence suggests that dupilumab might be an effective treatment for Ulcerative Colitis?

Research shows that dupilumab, one of the treatments under study in this trial, may help treat ulcerative colitis (UC). Studies on similar diseases have demonstrated significant symptom improvements, with some patients experiencing up to a 75.9% reduction in disease signs after 16 weeks. Dupilumab blocks certain proteins in the immune system that cause inflammation. This action is believed to reduce UC symptoms, which involve inflammation of the colon. While specific data on UC is still being collected, early results in related conditions appear promising. Participants in this trial may receive either dupilumab or a placebo to evaluate its effectiveness for UC. ^{4 6 7 8 9}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

You have a condition called intestinal failure or short bowel syndrome.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Placebo

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

In a study involving 49 patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in Japan, dupilumab significantly reduced nasal polyp size, nasal congestion, and sinus opacification compared to placebo, demonstrating its efficacy in improving symptoms after 24 weeks of treatment.

Dupilumab was well tolerated among participants, with the most common side effect being nasopharyngitis, indicating a favorable safety profile consistent with previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan. Fujieda, S., Matsune, S., Takeno, S., et al.[2021]

In a real-life study of 12 patients with severe type-2 asthma, dupilumab treatment for 3 months led to significant improvements in asthma control (ACT score) and lung function (FEV1), indicating its efficacy in managing symptoms.

The treatment also resulted in a notable reduction in FeNO levels, a biomarker for type-2 inflammation, although blood eosinophil counts did not show significant change, suggesting that dupilumab effectively targets the IL4/IL13 pathway in asthma management.

NCBI (Pubmed)

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. Carpagnano, GE., Scioscia, G., Buonamico, E., et al.[2022]

In a study of 130 patients treated with dupilumab for severe chronic rhinosinusitis with nasal polyps over 18 months, there was a significant reduction in nasal polyposis and improvement in symptoms and quality of life.

The treatment was associated with a transient increase in blood eosinophils and a gradual decrease in total IgE levels, indicating potential changes in immune response, although IgG and IgA levels remained within normal ranges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab's Impact on Blood Parameters in Nasal Polyposis: 18-Month Follow-Up in Real Life. Loperfido, A., Ciofalo, A., Cavaliere, C., et al.[2023]

In a real-world study of 85 patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), dupilumab treatment led to a significant improvement in symptoms, as measured by the SNOT-22 questionnaire, with scores decreasing from an average of 60.56 at baseline to 14.37 after one year.

No serious adverse effects were reported during the treatment, indicating that dupilumab is a safe option for patients with CRSwNP, with effectiveness comparable to results seen in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. Kilty, SJ., Lasso, A.[2022]

Patients treated with Dupilumab showed a higher risk of contracting COVID-19, but the infections were generally less severe, suggesting that Dupilumab may have a protective effect against severe disease.

The analysis included data from the WHO global pharmacovigilance database, identifying 109 COVID-19 cases among Dupilumab users, indicating a need for further research to clarify the immunological mechanisms behind these observations.

NCBI (Pubmed)

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. Mahroum, N., Damiani, G., Watad, A., et al.[2022]

Dupilumab is an innovative monoclonal antibody that blocks the IL-4 receptor-α, affecting the immune response pathways related to IL-4 and IL-13.

There is currently limited data on how well patients taking dupilumab respond to vaccinations against SARS-CoV-2, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease. Abadeh, A., Lee, JK.[2023]

Dupilumab is a monoclonal antibody that effectively targets the IL-4 receptor, significantly improving symptoms and quality of life in adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) over 24 to 52 weeks in phase III studies.

The treatment was well tolerated and led to reductions in nasal polyp size, sinus opacification, and the need for systemic corticosteroids or nasal polyp surgery, showing benefits even in patients with comorbid asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Chronic Rhinosinusitis with Nasal Polyps. Hoy, SM.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05731128

NCT05731128 | A Study to Investigate the Efficacy and ... A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019XWEAY/nct05731128

A Study to Investigate the Efficacy and Safety of Dupilumab ... A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active ...

3. academic.oup.com academic.oup.com/ecco-jcc/article/18/Supplement_1/i1354/7586748

Journal of Crohn's and Colitis | Oxford Academic The phase 2 LIBERTY-UC SUCCEED study will evaluate the efficacy and safety of dupilumab therapy in adults with moderately to severely active UC with an ...

4. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s212_a_phase_2_study_design_to_investigate_the.332.aspx

S212 A Phase 2 Study Design to Investigate the Efficacy ... The Phase 2 LIBERTY-UC SUCCEED study will determine the efficacy and safety of DPL therapy in adults with moderately to severely active UC with a Type 2 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12504992/

Safety and Effectiveness Profile of Dupilumab in the Treatment ... In particular, a significant improvement in disease signs and symptoms was observed as early as 16 weeks of treatment (a 75.9% reduction in EASI ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5589101/

Dupilumab in the management of moderate-to-severe ... Regeneron Pharmaceuticals Study to assess the efficacy and long-term safety of dupilumab (REGN668/SAR231893) in adult patients with moderate-to-severe atopic ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02379052

NCT02379052 | Study of Dupilumab in Adult Participants ... To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE; To assess the effect ...

9. ema.europa.eu ema.europa.eu/en/documents/rmp-summary/dupixent-epar-risk-management-plan_en.pdf

eu-risk management plan for dupixent® (dupilumab) - EMA This section presents a summary of non-clinical safety data for dupilumab. ... To describe long-term safety of dupilumab in terms of the incidence ...