Dupilumab for Esophagitis
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Sanofi
Must not be taking: Topical corticosteroids, Dupilumab
Disqualifiers: Hypereosinophilic syndrome, Crohn's, others
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.
Duration of study period (per participant)
* Screening period: Up to 12 weeks before Week 0
* Randomized double-blind period: 24 weeks
* Open label period: 104 weeks
* Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.
There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Will I have to stop taking my current medications?
The trial requires that you stop taking swallowed topical corticosteroids at least 8 weeks before starting. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is dupilumab generally safe for humans?
Dupilumab has a favorable safety profile with few, reversible side effects in various conditions, including atopic dermatitis and asthma. It is generally considered safe, although it may cause some eye-related side effects and increased blood eosinophils (a type of white blood cell) in some cases.
12345What makes the drug Dupilumab unique for treating eosinophilic esophagitis?
Dupilumab is unique because it is the first drug approved specifically to treat eosinophilic esophagitis, a condition with no prior approved treatments. It works by blocking certain proteins (IL-4 and IL-13) involved in inflammation, which is different from other treatments that may not target these specific pathways.
46789Eligibility Criteria
Adults with a confirmed diagnosis of Eosinophilic Esophagitis (EoE) who experience at least two episodes of difficulty swallowing solid food per week and weigh over 40 kg can join. Those without proper biopsy confirmation or outside the weight criteria cannot participate.Inclusion Criteria
A documented diagnosis of EoE by endoscopic biopsy
Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
I weigh at least 40 kg.
+1 more
Exclusion Criteria
Active Helicobacter pylori infection
Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Up to 12 weeks
1 visit (in-person)
Randomized double-blind treatment
Participants receive either dupilumab or placebo in a double-blind manner
24 weeks
10 site visits, 5 direct-to-participant IMP delivery visits
Open-label treatment
Participants receive open-label dupilumab treatment
104 weeks
10 site visits, 5 direct-to-participant IMP delivery visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 12 weeks
Participant Groups
The study is testing Dupilumab against a placebo to see its effects on esophageal function in EoE patients. Initially, participants are randomly assigned to receive either Dupilumab or placebo for six months, followed by everyone receiving Dupilumab for an additional two years.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Subcutaneous injection (SC) as per protocol
Group II: PlaceboPlacebo Group1 Intervention
SC injection as per protocol
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 NearbySelect from list below to view details:
University of North Carolina School of Medicine Site Number : 8400007Chapel Hill, NC
Investigational Site Number : 1240004Vancouver, Canada
Cleveland Clinic - Cleveland- Site Number : 8400009Cleveland, OH
Investigational Site Number : 1240002Montreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Safety update: dupilumab and ocular adverse reactions. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management. Drug Safety Update 2022;16(4): 1.
[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. [2023]Dupilumab is a humanized IgG4 monoclonal antibody that targets the IL-4 receptor inhibiting the signaling of interleukin-4 and interleukin-13, two major cytokines in type 2 inflammatory diseases such as atopic dermatitis, asthma and nasosinusal polyposis. Since its approval for atopic dermatitis in 2017, the molecule has occasionally been used off-label in several dermatological conditions where standard treatments are often disappointing.Furthermore, what emerges from the data currently in the literature is a favourable safety profile with few, reversible side effects.
Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. [2023]Long-term management options that specifically target the underlying inflammation in eosinophilic oesophagitis are needed. Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13; we aimed to assess its long-term efficacy and safety in adults and adolescents with eosinophilic oesophagitis enrolled in part B of the LIBERTY EoE TREET study who continued to part C (part B-C).
Dupilumab: First Global Approval. [2022]Dupilumab (Dupixent®) is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α (IL-4Rα) subunit. Dupilumab inhibits the signalling of the type 2 cytokines IL-4 and IL-13 and was co-developed by Regeneron Pharmaceuticals and Sanofi as a potential therapeutic agent for the treatment of atopic or allergic diseases. In March 2017 dupilumab received its first global approval, in the USA, for use in the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab is in preregistration for this indication in the EU. In addition, dupilumab is currently under phase III development across the world for the treatment of asthma and nasal polyposis as well as for atopic dermatitis in paediatric patients. The agent has also entered phase II development in the USA for the treatment of eosinophilic oesophagitis. This article summarizes the milestones in the development of dupilumab leading to this first approval for the treatment of moderate-to-severe atopic dermatitis in adults.
Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. [2022]Background: Dupilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-4 receptor and inhibits the signaling of IL-4 and IL-13. It is approved for treating asthma and other type-2 inflammatory diseases. There is a conflict in the literature regarding the safety and efficacy of dupilumab. Thus, we aimed to assess the safety and efficacy of dupilumab in patients with moderate to severe asthma. Methods: Six databases (PubMed, Embase, Scopus, Web of Science, Cochrane library, and clinicaltrials.gov registry) were searched until January 2022. We included randomized controlled trials that compared dupilumab with the placebo in moderate to severe asthma patients. We extracted the data at 12 and 24 weeks and analyzed them using review manager 5.4. Findings: Thirteen trials were included. Dupilumab significantly improved the forced expiratory volume in 1 s, asthma control questionnaire score, the fraction of exhaled nitric oxide level, and immunoglobulin E level at 12 and 24 weeks (p < 0.05). However, it was associated with increased blood eosinophils at 12 and 24 weeks. Dupilumab was generally a safe agent for asthmatic patients. It showed no significant difference compared with the placebo regarding most adverse events. Conclusion: Dupilumab improves pulmonary function and reduces local and systemic inflammatory markers with minimal adverse events in patients with moderate to severe asthma.
Dupixent, a New Entrant In the Asthma Lists. [2019]Sanofi and Regeneron's Dupixent (dupilumab)-which is already approved for atopic dermatitis-has an FDA action date of October 20 for its asthma indication. It will join Nucala, (mepolizumab), Cinqair (reslizumab), and Fasenra (benralizumab) as a monoclonal antibody approved as a treatment for the type 2 inflammation phenotype in severe asthma.
New Indication for Dupilumab. [2022]Dupilumab (Dupixent) has been approved to treat eosinophilic esophagitis in adults and children ages 12 years and older who weigh at least 40 kilograms. This is the first drug approved to treat this disease.
Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]Dupilumab is a monoclonal antibody against the IL-4/IL-13 receptor-subunit approved for the treatment of moderate-severe atopic dermatitis (AD). Some attempts to increase dose interval have been described in both trial and real-world settings.
The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study. [2022]Dupilumab is an antibody against interleukin-4 receptor α, used in the treatment of atopic dermatitis (AD).