Atopic KeratoconjunctivitisPhase 2NCT04296864
Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)
A Phase 2 study testing Dupilumab in people with Atopic Keratoconjunctivitis, run by Andover Eye Associates at 20 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Keratoconjunctivitis
- What is being tested?
- Dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 Feb 2020to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- have known contraindications or sensitivity to the use of any of the study drug(s) or their components, or any other medications required by the protocol;
- wear contact lenses for at least 48 hours prior to and during the study trial period;
- have a corneal ulcer in either eye;
- have a presence or history of ocular herpes or varicella-zoster infections in either eye;
- have uncontrolled ocular hypertension or glaucoma in either eye;
- have prior (within 30 days of beginning investigational product) or anticipated concurrent use of an investigational product or device during the study period;
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- have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's study participation;
- manifest in either eye symblepharon, significant conjunctival scarring, and/or fornix shortening;
- have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
- have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit
- be a female who is currently pregnant, planning a pregnancy, or lactating;
- have any previous exposure to dupilumab (unless discontinuation of exposure was due to a non-medical reason);
- have treatment with a live (attenuated) vaccine during the study;
- have an untreated parasitic (helminth) infection prior to Visit 2 and during the study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites, 16 recruiting
- Recruiting
Andover Eye Associates
Andover, Massachusetts, 01810
- Withdrawn
University of Michigan- Kellogg Eye Center
Ann Arbor, Michigan, 48105
- Recruiting
NC Eye Associates
Apex, North Carolina, 27502
Cheryl Salter
- Recruiting
Vantage EyeCare, LLC.
Bala-Cynwyd, Pennsylvania, 19004
- Recruiting
Tracie Malsom
Fargo, North Dakota, 58103
Kayla Geyer
- Completed
Northwell Health Physician Partners Ophthalmology at Great Neck
Great Neck, New York, 11021
- Recruiting
Gerald W. Zaidman, MD
Hawthorne, New York, 10532
- Completed
Encore Medical Research, LLC
Hollywood, Florida, 33021
- Recruiting
Silverstein Eye Centers
Kansas City, Missouri, 64133
- Recruiting
Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, 80120
- Recruiting
Premiere Practice Management, LLC
Los Angeles, California, 90013
- Recruiting
Blink Research Center
Memphis, Tennessee, 38119
Brandy Robertson
- Recruiting
Kannar Eye Care
Pittsburg, Kansas, 66762
Megan Compton
- Withdrawn
Eye Associates of Central Texas
Round Rock, Texas, 78681
- Recruiting
Periman Eye Institute
Seattle, Washington, 98119
Christeen DeNeui
- Recruiting
Vita Eye Clinic
Shelby, North Carolina, 28150
- Recruiting
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
- Recruiting
Mercy Clinic Eye Specialists
Springfield, Missouri, 65804
- Recruiting
Ophthalmology Associates
St Louis, Missouri, 63131
Dawn Weimers
- Recruiting
St. Louis Eye Institute
Town and Country, Missouri, 63017
Abigail Carpenter
About this study
Official title: 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)
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).
- Conditions
- Atopic Keratoconjunctivitis
- Being tested
- Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo of Dupilumab Receives: Drug: Dupilumab |
| Dupilumab | Experimental | one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment responders
- Determination of the percentage of treatment responders as defined as meeting one or more of the below at the end of the 16-week treatment period (Visit 7) as compared to Visit 2 (baseline):
- ≥ 1 grade improvement in lid margin redness (0-3 scale, NOT allowing half unit increments)
- ≥ 1 grade improvement in lid excoriation (0-3 scale, NOT allowing half unit increments)
- ≥ 1 grade improvement in lid thickening/lichenification (0-3 scale, NOT allowing half unit increments)
- ≥ 1 grade improvement in changes in mucocutaneous junction (0-3 scale, NOT allowing half unit increments)
- ≥ 4 grade improvement in a composite symptom score (the sum of scores for ocular itching, tearing/watery eyes, ocular discomfort, photophobia, and nonpurulent mucous discharge)
- >2 grade improvement in an individual symptom from Visit 2 (baseline)
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start10 Feb 2020
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic KeratoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andover Eye Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistics & Data Corporation, Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296864
- Sponsor's protocol ID
- 18-290-0002
- Status last verified
- Jan 2024
- First submitted
- 2 Mar 2020
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04296864
- Acronym / sponsor ID
- 18-290-0002
- Conditions
- Atopic Keratoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Andover Eye AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- Statistics & Data Corporation, Regeneron Pharmaceuticals
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DupilumabPlacebo of Dupilumab |
| Dupilumab | Experimental | Drug: Dupilumabone loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (14 listed)
- have known contraindications or sensitivity to the use of any of the study drug(s) or their components, or any other medications required by the protocol;
- wear contact lenses for at least 48 hours prior to and during the study trial period;
- have a corneal ulcer in either eye;
- have a presence or history of ocular herpes or varicella-zoster infections in either eye;
- have uncontrolled ocular hypertension or glaucoma in either eye;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: Dupixentmonoclonal antibody | Drug | Dupilumab, Placebo |
Primary outcome
Percentage of treatment responders
Time frame: Baseline to Week 16
• Determination of the percentage of treatment responders as defined as meeting one or more of the below at the end of the 16-week treatment period (Visit 7) as compared to Visit 2 (baseline): * ≥ 1 grade improvement in lid margin redness (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in lid excoriation (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in lid thickening/lichenification (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in changes in mucocutaneous junction (0-3 scale, NOT allowing half unit increments) * ≥ 4 grade improvement in a composite symptom score (the sum of scores for ocular itching, tearing/watery eyes, ocular discomfort, photophobia, and nonpurulent mucous discharge) * >2 grade improvement in an individual symptom from Visit 2 (baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Atopic Keratoconjunctivitis, run by Andover Eye Associates at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kara Quealy (978-332-9417, kquealy@andovereye.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treatment responders (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.