NL-OMON54290招募中3 期
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis - Long Term Extension Prurigo Nodularis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Galderma
- 入组人数
- 10
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
- •Inclusion Criteria
- •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
- •re-enter in the LTE study within 28 days of exiting the durability study
- •(selected countries/ selected sites)
- •Note: Transfer into the LTE study from a phase 3 study can occur immediately
- •but must occur within 56 days of lead-in study completion, provided other
- •eligibility criteria are met. Subjects from the phase 2 study, subjects who
- •rollover between 29 to 56 days after completion of a phase 3 study, or subjects
- •who discontinued study drug but otherwise completed a phase 3 study must
- •undergo a separate screening visit prior to the baseline visit. Subjects from a
- •phase 3 study who do not rollover within 56 days are ineligible for
- •participation in the LTE.
- •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. See Appendix 1 for details. 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
- •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
- 另有 2 项未显示
排除标准
- •Exclusion Criteria:
- •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
- •2. Body weight < 30 kg.
- •3. Having received any of the following treatments in Table 3 within the
- •specified timeframe before the baseline visit or re-entry Week R0 visit
- •4. Pregnant women (positive pregnancy test result at screening or 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
- •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 visit
- •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
- •a. Had an exacerbation of asthma requiring hospitalization in the preceding 12
- •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.
- •Note: In the event that PEF is <80% of the predicted value at screening in
- •patients without any history of asthma or in patients with history of asthma
- •but with the ACT score >19, PEF testing can be repeated once within 48 hours.
- •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.
- •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.
- •Note: Subjects with a positive HBcAb and a negative HBsAg can be included in
- •this clinical study if hepatitis B surface antibody is positive (considered
- •immune after a natural infection). Subjects with negative confirmatory test for
- •HCV can be included in this clinica
研究者
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