Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Andover Eye Associates
- Study ID
- NCT04296864
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Atopic Keratoconjunctivitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab — DRUGmonoclonal antibody
Study Details
This is a multi-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy, safety, and tolerability study evaluating the efficacy of Dupilumab in the treatment of signs and symptoms of atopic keratoconjunctivitis (AKC).
Key Dates
- Start date
- Feb 10, 2020
- Status verified
- Jan 2024
- Primary completion
- Jan 31, 2025
- Completion
- Jan 31, 2025
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboPlacebo of Dupilumab
- Experimental: Dupilumabone loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks
Primary Outcome Measure
Percentage of treatment responders [ Time Frame: Baseline to Week 16 ]
Central Contacts
- Kara Quealy978-332-9417
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Premiere Practice Management, LLC | Los Angeles | California | 90013 | - |
| Colorado Eye Consultants/Corneal Consultants of Colorado | Littleton | Colorado | 80120 | - |
| Encore Medical Research, LLC | Hollywood | Florida | 33021 | - |
| Kannar Eye Care | Pittsburg | Kansas | 66762 | Megan Compton |
| Andover Eye Associates | Andover | Massachusetts | 01810 | - |
| University of Michigan- Kellogg Eye Center | Ann Arbor | Michigan | 48105 | - |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | - |
| Mercy Clinic Eye Specialists | Springfield | Missouri | 65804 | - |
| Ophthalmology Associates | St Louis | Missouri | 63131 | Dawn Weimers |
| St. Louis Eye Institute | Town and Country | Missouri | 63017 | Abigail Carpenter |
| Northwell Health Physician Partners Ophthalmology at Great Neck | Great Neck | New York | 11021 | - |
| Gerald W. Zaidman, MD | Hawthorne | New York | 10532 | - |
| NC Eye Associates | Apex | North Carolina | 27502 | Cheryl Salter |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | - |
| Tracie Malsom | Fargo | North Dakota | 58103 | Kayla Geyer |
| Vantage EyeCare, LLC. | Bala-Cynwyd | Pennsylvania | 19004 | - |
| Blink Research Center | Memphis | Tennessee | 38119 | Brandy Robertson |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | - |
| Eye Associates of Central Texas | Round Rock | Texas | 78681 | - |
| Periman Eye Institute | Seattle | Washington | 98119 | Christeen DeNeui |
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