A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF REGN3500 MONOTHERAPY AND COMBINATION OF REGN3500 PLUS DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
- Conditions
- atopic dermatitiseczema10014982
- Registration Number
- NL-OMON48003
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
A patient must meet the following criteria to be eligible for inclusion in the
study:
1. Male or female, 18 to 75 years
2. Chronic AD, according to American Academy of Dermatology Consensus Criteria
(Eichenfield, 2014), that has been present for at least 3 years before the
screening visit
3. EASI score *16 at the screening and baseline visits
4. IGA score *3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is
severe) at screening
and baseline visits
5. *10% BSA of AD involvement at the screening and baseline visits
6. Baseline peak Pruritus NRS score for maximum itch intensity *4
NOTE: Baseline peak Pruritus NRS score for maximum itch intensity will be
determined
based on the average of daily NRS scores for maximum itch intensity (the daily
score
ranges from 0 to 10) during the 7 days immediately preceding randomization. A
minimum
of 4 daily scores out of the 7 days is required to calculate the baseline
average score. For
patients who do not have at least 4 daily scores reported during the 7 days
immediately
preceding the planned randomization date, randomization should be postponed
until this
requirement is met, but without exceeding the 35-day maximum duration for
screening.
7. Documented recent history (within 6 months before the screening visit) of
inadequate
response to topical AD medication(s) or for whom topical treatments are
medically
inadvisable (eg, intolerance, because of important side effects, or safety
risks).
NOTE:
* Inadequate response is defined as failure to achieve and maintain remission
or a low
disease activity state (comparable to IGA 0<=clear to 2<=mild) despite treatment
with a
daily regimen of topical corticosteroids (TCS) of medium to higher potency (±
topical
calcineurin inhibitors [TCI] as appropriate), applied for at least 28 days or
for the
maximum duration recommended by the product prescribing information (eg, 14 days
for super-potent TCS), whichever is shorter.
* Patients with documented systemic treatment for AD (eg, systemic
immunosuppressant
drugs like cyclosporine, methotrexate, corticosteroids, etc) in the past 6
months are also
considered to be inadequate responders to topical treatments and are
potentially eligible
for treatment with dupilumab and REGN3500 after appropriate washout.
* Important side effects or safety risks are those that outweigh the potential
treatment
benefits and include intolerance to treatment, hypersensitivity reactions,
significant
skin atrophy, and systemic effects, as assessed by the investigator or by the
patient*s
treating physician.
* Acceptable documentation includes contemporaneous chart notes that record
topical
medication prescription and treatment outcome, or investigator documentation
based
on communication with the patient*s treating physician. If documentation is
inadequate, potential patients may be offered a course of treatment with a
daily regimen
of TCS of medium or higher potency (±TCI as appropriate), applied for at least
28 days
during the screening period or for the maximum duration recommended by the
product
prescribing information, whichever is shorter. Patients who demonstrate
inadequate
response during this period, as defined above, will be eligible for inclusion
in the study
following appropriate
A patient who meets any of the following criteria will be excluded from the
study:
1. Prior participation in an anti-IL-33 class antibody (including not limited
to REGN3500) or anti-IL4R* class antibody (including but not limited to
dupilumab) clinical study; past treatment with or current treatment with
dupilumab or another anti-IL4R* treatment
2. Body mass index <16 kg/m2
3. Treatment with an investigational drug within 8 weeks or within 5 half-lives
(if known), whichever is longer, before the baseline visit
4. Having used any of the following treatments within 4 weeks before the
baseline visit or any condition that, in the opinion of the investigator, is
likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-*, Janus kinase inhibitors,
azathioprine, methotrexate, etc)
- Phototherapy for AD
5. Treatment with TCS, TCI, or topical crisaborole within 1 week before the
baseline visit
6. Treatment with biologics as follows:
- Any cell-depleting agents including but not limited to rituximab: within 6
months before the baseline visit, or until lymphocyte count returns to normal,
whichever is longer
- Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline
visit, whichever is longer
7. Initiation of treatment of AD with prescription moisturizers or moisturizers
containing additives such as ceramide, hyaluronic acid, urea, or filaggrin
degradation products during the screening period (patients may continue using
stable doses of such moisturizers if initiated before the screening visit)
8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4
weeks of the baseline visit
9. Planned or anticipated use of any prohibited medications and procedures
during study treatment
10. Treatment with a live (attenuated) vaccine within 12 weeks before the
baseline visit
11. Active chronic or acute infection requiring treatment with systemic
antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within
2 weeks before the baseline visit, or superficial skin infections within 1 week
before the baseline visit
NOTE: patients may be re-screened after infection resolves
12. Known or suspected history of immunosuppression, including history of
invasive opportunistic infections (eg, tuberculosis [TB]*, histoplasmosis,
listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite
infection resolution: or unusually frequent, recurrent, or prolonged
infections, per investigator judgment
*Patients with a positive TB QuantiFERON test result at screening will be
excluded from the study.
13. History of human immunodeficiency virus (HIV) infection or positive HIV
serology at screening
14. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
15. At baseline, presence of any conditions listed as criteria for study drug
discontinuation
16. Presence of skin comorbidities that may interfere with study assessments
17. History of cancer, with the exceptions of:
- Patients with adequately treated basal cell carcinoma or carcinoma in situ of
the cervix.
- Patients with other malignanc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in the study is the percent change in EASI score from<br /><br>baseline to week 16.</p><br>
- Secondary Outcome Measures
Name Time Method