EUCTR2019-004294-13-SE进行中（未招募）1 期
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis - A long-term study to assess the safety and efficacy of nemolizumab in subjects with P
Galderma S.A.0 个研究点目标入组 508 人开始时间: 2020年4月16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
- 508
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
- •Individuals must meet all of the following criteria at screening and baseline, as applicable, to be included in the study (individuals re-entering from the phase 3b durability study RD.06.SPR.203890 must meet all inclusion criteria at re-entry Week R0):
- •1. Subjects who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including:
- •a. Subjects who completed the treatment period in a phase 3 pivotal study (RD.06.SPR.202685 or RD.06.SPR.203065) and enroll within 56 days
- •b. Subjects who were previously randomized in the nemolizumab phase 2a PN study (RD.03.SPR.115828).
- •c. Subjects who completed through Week 24 of the phase 3b durability study (RD.06.SPR.203890) or who exit the study due to relapse may be eligible to reenter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
- •2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- •Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below:
- •True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
- •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 an adequate and approved method of contraception);
- •Note: Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (eg, condom) together with a spermicide is not acceptable
- •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
- •3. 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 the study.
- •4. Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the subject using an electronic handheld device provided for this study;
- •5. Understand and sign an informed consent form before any investigational procedure(s) are performed.
- •Are the trial subjects under 18? no
- •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 359
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 149
排除标准
- •Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study (individuals re-entering from the phase 3b durability study RD.06.SPR.203890 meeting any of the following criteria at the re-entry Week R0 visit are ineligible):
- •1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject;
- •2. Body weight < 30 kg;
- •3. Having received any of the treatments listed in Table 7 in the protocol within the specified timeframe before the baseline or re-entry Week R0 visit;
- •4. Pregnant women (positive pregnancy test result at screening, baseline or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study;
- •5. Any medical or psychological condition 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);
- •6. Planning or expected to have a major surgical procedure during the clinical study;
- •7. Subjects unwilling to refrain from using prohibited medications during the clinical study;
- •8. History of alcohol or substance abuse within 6 months of the screening or re-entry Week R0 visit.
- •For subjects who do not rollover within 28 days from a prior nemolizumab study or who completed study visits but prematurely discontinued study drug, the following exclusion criteria also apply:
- •9. Subjects with a history of asthma meeting 1 or more of the following criteria:
- •a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months;
- •b. 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;
- •c. Asthma Control Test (ACT) =19 (only for subjects with a history of asthma) at screening and baseline;
- •d. Peak expiratory flow (PEF) <80% of the predicted value.
- •10. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis;
- •11. 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 8.4.2 of the protocol.
- •12. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at screening.
- •13. Chronic pruritus resulting from another active condition than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (eg, primary biliary cirrhosis), or di
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