NL-OMON48003已完成2 期
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 - REGN3500
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A patient must meet the following criteria to be eligible for inclusion in the
- •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
- •based on the average of daily NRS scores for maximum itch intensity (the daily
- •ranges from 0 to 10) during the 7 days immediately preceding randomization. A
- •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
- •requirement is met, but without exceeding the 35-day maximum duration for
- •7. Documented recent history (within 6 months before the screening visit) of
- •response to topical AD medication(s) or for whom topical treatments are
- •inadvisable (eg, intolerance, because of important side effects, or safety
- •* Inadequate response is defined as failure to achieve and maintain remission
- •disease activity state (comparable to IGA 0<=clear to 2<=mild) despite treatment
- •daily regimen of topical corticosteroids (TCS) of medium to higher potency (±
- •calcineurin inhibitors [TCI] as appropriate), applied for at least 28 days or
- •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
- •benefits and include intolerance to treatment, hypersensitivity reactions,
- •significant
- •skin atrophy, and systemic effects, as assessed by the investigator or by the
- •treating physician.
- •* Acceptable documentation includes contemporaneous chart notes that record
- •medication prescription and treatment outcome, or investigator documentation
- •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
- •during the screening period or for the maximum duration recommended by the
- •prescribing information, whichever is shorter. Patients who demonstrate
- •response during this period, as defined above, will be eligible for inclusion
- 另有 2 项未显示
排除标准
- •A patient who meets any of the following criteria will be excluded from the
- •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
- 另有 6 项未显示
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