EUCTR2019-001888-75-BE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 Moderate-to-Severe Atopic Dermatitis
Galderma S.A.0 个研究点目标入组 750 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 (ie, fertile, following
- •menarche and until becoming postmenopausal unless permanently
- •sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate 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. *In Germany only, if a subject has reached Tanner stage 3 breast development, even if not having
- •menarche, the subject will be considered a female of childbearing
- •Adequate and approved methods of contraception applicable for the
- •subject and/or her partner are defined below:
- •- Progestogen-only oral hormonal contraception;
- •- Combination of male condom with cap, diaphragm, or sponge with
- •spermicide (double barrier methods) (*In Germany only, double barrier
- •methods are not considered a highly effective method of contraception);
- •- Combined (estrogen- and progestogen-containing) oral, intravaginal,
- •or transdermal hormonal contraception;
- •- Injectable or implanted hormonal contraception;
- •- Intrauterine devices or intrauterine hormone-releasing system;
- •- Bilateral tubal ligation or tube insert (such as the Essure system) at
- •least 3 months before the study;
- •- Bilateral vasectomy of partner at least 3 months before 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, confirmed with follicle-stimulating hormone (FSH) level in the postmenopausal range;
- •- Documented hysterectomy, bilateral salpingectomy 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
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 2 or more 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 baseline visit, any
- •infection requiring treatment with oral or parenteral antibiotics,
- •antivirals, antiparasitics or antifungals within 2 weeks before the
- •baseline visit, or any confirmed or suspected coronavirus disease
- •(COVID)-19 infection within 2 weeks before the screening or baseline
- •visit. Subjects may be rescreened once the infection has
- •resolved. Resolution of COVID-19 infection can be confirmed by recovery
- •assessment methods, as described in Section 8.3.4.2;
- •Note: Subjects with chronic, stable use of prophylactic treatment for
- •recurrent herpes viral infection can be included in this study.
- •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, after a full treatment course of 16 weeks with
- •dupilumab, experienced worsening of their AD or failed to achieve
- •minimal improvement (eg, = 10% reduction in EASI or no reduction in
- •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 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
- •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 untreated latent tuberculosis infection.
- •Note: Subjects who have a documented history of completion of an appropriate TB treatment regimen for active or latent TB with no history of re-exposure to TB since their treatment was completed are eligible to participate in the study.
- •15. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- •16. Presence of confounding skin condition that may interfere with study
- •assessments (eg, Netherton syndrome, psoriasis,
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