Dupilumab for Conjunctivitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Dupilumab, a medication, to evaluate its effectiveness for individuals with atopic keratoconjunctivitis (AKC), a condition causing red, itchy, and uncomfortable eyes. Participants will receive either Dupilumab or a placebo (a harmless substitute) to compare results. The study aims to determine if Dupilumab can safely reduce the signs and symptoms of AKC. Individuals with a history of AKC or atopic dermatitis with active eye symptoms who can manage injections may be suitable for this study. As a Phase 2 trial, this research measures Dupilumab's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in AKC treatment.
Do I need to stop my current medications for the trial?
If you are already on treatment for atopic keratoconjunctivitis (AKC), you must have been on it for at least 2 weeks for some medications and 3 months for others, and you need to continue taking them throughout the study.
Is there any evidence suggesting that Dupilumab is likely to be safe for humans?
Research has shown that Dupilumab is generally well-tolerated in clinical studies. However, some side effects require attention. In studies involving patients with conditions like atopic dermatitis, Dupilumab was associated with a higher rate of eye inflammation (conjunctivitis) compared to a placebo. One study found that 16% of patients on Dupilumab experienced eye inflammation, while only 1% of the placebo group did. Another study reported eye inflammation in 3% of patients on Dupilumab, compared to 1% of those taking a placebo. Importantly, all patients with eye inflammation in these studies recovered. Overall, while Dupilumab can cause some eye issues, it has a low rate of serious side effects.12345
Why do researchers think this study treatment might be promising for conjunctivitis?
Researchers are excited about Dupilumab for conjunctivitis because it offers a novel approach by targeting the immune system. Most treatments for conjunctivitis, like antihistamines and decongestants, focus on relieving symptoms. In contrast, Dupilumab works by blocking the IL-4 and IL-13 pathways, which play a crucial role in the inflammatory response. This mechanism could lead to more effective and long-lasting relief from conjunctivitis symptoms, offering hope for patients who do not find adequate relief with current options.
What evidence suggests that Dupilumab might be an effective treatment for atopic keratoconjunctivitis?
Research has shown that Dupilumab, which participants in this trial may receive, can help with eye problems similar to those in atopic keratoconjunctivitis (AKC). In studies for other conditions, many patients experienced reduced eye inflammation. Dupilumab is already effective for conditions like atopic dermatitis, where it alleviated skin issues and reduced inflammation. Its safety for long-term use suggests potential effectiveness for AKC as well. Early results are promising, indicating Dupilumab may improve both the signs and symptoms of AKC.16789
Are You a Good Fit for This Trial?
Adults with active atopic keratoconjunctivitis (AKC) who can self-administer or receive injections, and are not pregnant or lactating. Participants must have stable AKC treatments prior to the study and agree to use birth control. Excluded are those with recent contact lens use, eye surgery, certain eye conditions, abnormal blood pressure, live vaccine treatment, untreated infections, drug sensitivities or other health risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a loading dose of Dupilumab 600 mg followed by 300 mg weekly for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Trial Overview
The trial is testing Dupilumab's effectiveness in treating signs and symptoms of AKC compared to a placebo. It's a multi-center study where participants are randomly assigned to either the test drug or placebo without knowing which one they're receiving (double-masked).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks
Placebo of Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andover Eye Associates
Lead Sponsor
Statistics & Data Corporation
Collaborator
Statistics & Data Corporation
Industry Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
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
Citations
Conjunctivitis in Adults with Atopic Dermatitis Treated with ...
Most conjunctivitis events recovered/resolved (84%) or were resolving/recovering (12%) at study end. Mean ± SD time to recovery from the initial ...
Conjunctivitis in dupilumab clinical trials - PMC
Patients who achieved high‐level efficacy outcomes [IGA 0/1 or ≥ 75% improvement from baseline Eczema Area and Severity Index (EASI 75)] in the monotherapy ...
Adult Real-World Data | DUPIXENT® (dupilumab)
Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual ...
Dupilumab provides sustained effectiveness on patient- ...
At follow-up, overall work impairment decreased from 40.1% to 16.3% to 13.3% in adults. Furthermore, class I obesity and itch-dominant patients generally had ...
Dupilumab-associated ocular surface disease - eye
Dupilumab has been found to significantly improve signs and symptoms of AD and is considered a safe treatment for long-term use.
safety data and study designs in adults
In SINUS-52 (52 weeks), the frequency of conjunctivitis was 3% in the DUPIXENT group compared with 1% in the placebo group; all of these subjects recovered.1 ...
DUPIXENT® Full Prescribing Information
In adult subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared to 1% in the placebo group in the 24-week safety pool; ...
Adult Clinical Trial Safety Profile
Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group1; Conjunctivitis was reported in 16% of the DUPIXENT + TCS ...
Conjunctivitis in patients with atopic dermatitis treated ...
Data from phase phase 2 and 3 studies have revealed that dupilumab generally has a low rate of adverse events, although an increased incidence of mild-to- ...
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