Dupilumab for Conjunctivitis

Recruiting at 18 trial locations

Overseen By Kara Quealy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andover Eye Associates

Must be taking: Topical corticosteroids, oral antihistamines

Disqualifiers: Contact lenses, Corneal ulcer, Ocular herpes, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

42 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

I can self-inject medication or have someone to help me.

Have a calculated visual acuity of 0.7 logarithm of the minimum angle of resolution (logMAR) or better in at least one eye (Snellen equivalent of 20/100) and 1.0 logMAR (or count fingers) or better in the fellow eye (Snellen equivalent of 20/200) as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart.

I am not pregnant, not breastfeeding, and will use birth control during and after the study.

Exclusion Criteria

I have uncontrolled high eye pressure or glaucoma.

I will not receive any live vaccines during the study.

Wear contact lenses for at least 48 hours prior to and during the study trial period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a loading dose of Dupilumab 600 mg followed by 300 mg weekly for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Dupilumab Experimental Treatment 1 Intervention

one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo of Dupilumab

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?

Andover Eye Associates

Lead Sponsor

Trials

1

Recruited

40+

Statistics & Data Corporation

Collaborator

Trials

4

Recruited

1,000+

Statistics & Data Corporation

Industry Sponsor

Trials

5

Recruited

1,100+

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40388089/

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6850316/

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 ...

3. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/adult-real-world-results

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224006418

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 ...

5. nature.com nature.com/articles/s41433-020-01379-9

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.

6. dupixenthcp.com dupixenthcp.com/crswnp/efficacy/safety-data-and-design

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 ...

7. regeneron.com regeneron.com/downloads/dupixent_fpi.pdf

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; ...

8. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/safety-clinical-trial

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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7216785/

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- ...