EUCTR2019-001888-75-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderateto- Severe Atopic Dermatitis - RD.06.SPR.118169
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma SA
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects aged = 12 years at the screening visit.
- •Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study.
- •The sponsor will send a written communication to the site confirming that the study is open for enrollment of adolescents. Adolescents must not be enrolled in the study until such communication is received.
- •2. Chronic AD for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit.
- •3. EASI score = 16 at both the screening and baseline visits.
- •4. IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3
- •is moderate and 4 is severe) at both the screening and baseline visits.
- •5. AD involvement = 10% of body surface area (BSA) at both the screening and baseline visits.
- •6. Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit.
- •7. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI).
- •8. Agree to apply a moisturizer throughout the study from the screening visit; agree to apply authorized topical therapy from the screening visit and throughout the study as determined appropriate by the investigator.
- •9. Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- •This criterion also applies to a prepubertal female subject who begins menses during the study.
- •10. Female subjects of non-childbearing potential must meet one of the following criteria:
- •Absence of menstrual bleeding for 1 year prior to screening without any other medical reason
- •Documented hysterectomy or bilateral oophorectomy at least 3 months before screening
- •11. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the subject using an electronic handheld device provided for this study.
- •12. Understand and sign an informed consent form (and assent form, when applicable) before any investigational procedure(s) are performed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 589
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •1. Body weight < 30 kg.
- •2. Subjects meeting 1 or more of the following criteria at screening or baseline:
- •2a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- •2b. Reporting asthma that has not been well-controlled (ie, symptoms occurring on > 2 days per week, nighttime awakenings > 1-3 times per week, or some interference with normal activities) during the preceding 3 months.
- •2c. Asthma Control Test = 19 (only for subjects with a history of asthma).
- •2d. Peak expiratory flow < 80% of the predicted value.
- •3. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- •4. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit. Subjects may be rescreened once the infection has resolved.
- •5. Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit.
- •6. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit.
- •7. Having received any of the treatments specified in Table 3 reported in the protocol within the specified timeframe before the baseline visit.
- •8. Previous treatment with Nemolizumab.
- •9. Subjects who failed to respond clinically to previous treatment with a biologic (eg, dupilumab) or an oral Janus kinase inhibitor.
- •10. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
- •11. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 52 weeks before the baseline visit, or (2) actinic keratoses that have been treated and have no evidence of recurrence in the last 12 weeks.
- •12. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg,
- •monoclonal antibody) or to any of the study drug excipients.
- •13. History of intolerance to TCS or for whom TCS is not advisable (eg, hypersensitivity, significant skin atrophy).
- •14. Known active or latent tuberculosis infection.
- •15. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- •16. History of or current confounding skin condition (eg, Netherton syndrome, psoriasis, cutaneous Tcell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
- •17. Any medical or psychological condition or any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (> 3 × upper limit of normal [ULN]) in combination with elevated bilirubin (> 2 × ULN), at the screening visit that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (eg, poor venous access or needle-phobia).
- •18. Planned or expected major surgical procedure during th
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