A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

Who is this study for? Patients with Atopic Keratoconjunctivitis
What treatments are being studied? Dupilumab
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• be at least 18 years of age at Visit 1 of either gender and any race or ethnicity;

• provide written informed consent and sign the HIPAA form;

• be willing and able to follow all instructions and attend all study visits;

• if on an active therapy for AKC prior to Visit 1, such treatment must have been maintained stably for at least 2 weeks for topical corticosteroids, topical and oral antihistamines, topical mast cell stabilizers, and topical tacrolimus and at least 3 months for topical and oral cyclosporine, and systemic corticosteroids. Such therapy must remain current throughout duration of study;

• have a history of AKC or atopic dermatitis with a diagnosis of AKC at Visit 1 (by meeting inclusion 7 and 8);

• be able to self-administer or receive subcutaneous injections satisfactorily or have a caregiver at home routinely available for this purpose. If unable to administer at home, patients must be willing to come in to office to receive injections that do not coincide with a visit;

• present signs of active disease, defined as one or more of the following in at least one eye at Visit 2 (baseline):

‣ \>/=2 score in conjunctival redness AND

⁃ \>/=2 score in at least one of the following lid disease signs: i. lid margin redness ii. lid excoriation

• present symptoms of active disease, defined as having both of the following in at least one eye at Visit 2 (baseline):

‣ \>/=2.5 score in ocular itching AND

⁃ \>/=2 score for ocular discomfort;

• (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at exit visit; must not be lactating; and must agree to use at least one medically acceptable form of birth control throughout the study duration and for at least 14 days prior to the first dose of investigational product (Visit 2) and for 1 month after the last dose of investigational product. Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);

• 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.

Locations
United States
California
Premiere Practice Management, LLC
RECRUITING
Los Angeles
Colorado
Colorado Eye Consultants/Corneal Consultants of Colorado
RECRUITING
Littleton
Florida
Encore Medical Research, LLC
COMPLETED
Hollywood
Kansas
Kannar Eye Care
RECRUITING
Pittsburg
Massachusetts
Andover Eye Associates
RECRUITING
Andover
Michigan
University of Michigan- Kellogg Eye Center
WITHDRAWN
Ann Arbor
Missouri
Silverstein Eye Centers
RECRUITING
Kansas City
Mercy Clinic Eye Specialists
RECRUITING
Springfield
Ophthalmology Associates
RECRUITING
St Louis
St. Louis Eye Institute
RECRUITING
Town And Country
North Carolina
NC Eye Associates
RECRUITING
Apex
Vita Eye Clinic
RECRUITING
Shelby
North Dakota
Tracie Malsom
RECRUITING
Fargo
New York
Northwell Health Physician Partners Ophthalmology at Great Neck
COMPLETED
Great Neck
Gerald W. Zaidman, MD
RECRUITING
Hawthorne
Pennsylvania
Vantage EyeCare, LLC.
RECRUITING
Bala-cynwyd
Tennessee
Blink Research Center
RECRUITING
Memphis
Advancing Vision Research, LLC
RECRUITING
Smyrna
Texas
Eye Associates of Central Texas
WITHDRAWN
Round Rock
Washington
Periman Eye Institute
RECRUITING
Seattle
Contact Information
Primary
Kara Quealy
kquealy@andovereye.org
978-332-9417
Time Frame
Start Date: 2020-02-10
Estimated Completion Date: 2025-01
Participants
Target number of participants: 42
Treatments
Placebo_comparator: Placebo
Placebo of Dupilumab
Experimental: Dupilumab
one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks
Sponsors
Collaborators: Regeneron Pharmaceuticals, Statistics & Data Corporation
Leads: Andover Eye Associates

This content was sourced from clinicaltrials.gov