A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis. - Long-term nemolizumab in atopic dermatitis (RD.06.SPR.118163)

Galderma0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Galderma
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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: 12 至 64（—）

入选标准

•See protocol page 11:
•1. Adolescent subjects (aged 12-17) who have not participated in a previous
•nemolizumab study (selected countries/selected sites - See Appendix 3) or
•subjects who may benefit from study participation in the opinion of the
•investigator and had participated in a prior nemolizumab study for AD including:
•a. Subjects who completed the initial treatment period (Week 16 visit) in a
•Phase 3 pivotal study (SPR.118161 or SPR.118169) and do not qualify for the
•maintenance period;
•b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3
•pivotal study (SPR.118161 or SPR.118169);
•c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2
•vaccination safety study (SPR.118380);
•d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2
•adolescent PK/safety study (SPR.116912);
•e. Subjects who completed the treatment period (Week 24 visit) in the Phase 2b
•dose-ranging study (SPR.114322) and remain insufficiently controlled on topical
•therapy alone;
•f. Subjects who discontinued study medication in a prior study and completed
•required study visits prior to LTE participation (Week 16 visit for SPR.118161
•and SPR.118169 initial treatment period, Week 32 visit for SPR.118161 and
•SPR.118169 maintenance period; final study visits for SPR.118380 [Week 16],
•SPR.116912 [Week 16], SPR.114322 [Week 24], SPR.201591 [Week 16], and
•SPR.201593 [Week 13] , unless the subject experienced an AE that may present an
•unreasonable risk if study medication is continued.
•g. Subjects who completed the treatment period (Week 16) in the Phase 3b study
•(SPR.201591);
•h. Subjects who completed the treatment period (Week 13) in the Phase 2 DDI
•study (SPR.201593).
•Note(s): For ongoing studies, transfer into the LTE study should occur as soon
•as possible to minimize gaps in study medication dosing. Subjects who satisfy
•inclusion criteria 1a through 1c are permitted to enroll immediately into the
•LTE study, provided other eligibility criteria are met.
•Enrollment of subjects aged 12 to 17 years has been open after the IDMC has
•assessed interim safety data from the phase 2 study (SPR.116912) and provided
•recommendations to the sponsor, who then determined the eligibility of this age
•group for enrollment in the study. The sponsor sent a written communication to
•study sites confirming that the study is open for enrollment of adolescents.
•Adolescents could not be enrolled in the study until such communication was
•2. Agree to apply a moisturizer at least once daily throughout the study and
•agree to apply the authorized topical therapy, as determined appropriate by the
•investigator.
•3. Women 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
•Adequate and approved meth

排除标准

•See protocol page 12:
•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. Having received any of the following treatments in Table 3 within the
•specified timeframe before the baseline visit.
•3. Pregnant women (positive pregnancy test result at screening or baseline
•visit), breastfeeding women, or women planning a pregnancy during the clinical
•4. Any medical or psychological condition 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).
•5. Planning or expected to have a major surgical procedure during the clinical
•6. Subjects unwilling to refrain from using prohibited medications during the
•clinical study (see Section 8.4.9.2).
•Additional Exclusion Criteria: For new adolescent subjects or for subjects who
•do not rollover from a prior nemolizumab study within 28 days of completing
•final study assessments during the lead-in study:
•7. Body weight < 30 kg.
•8. Subjects meeting 1 or more of the following criteria at screening or
•8a. Had an asthma exacerbation requiring hospitalization in the preceding 12
•8b. Reporting asthma that has been not 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;
•8c. Asthma Control Test (ACT) <= 19 (only for subjects with a history of asthma);
•8d. Peak expiratory flow < 80% of the predicted value.
•Note: In the event that PEF is * 80% of the predicted value at the screening
•visit, PEF testing can be repeated once within 48 hours:
•For subjects without a history of asthma
•For subjects with a history of asthma but if the ACT score is >19 at
•9. Subjects with a current medical history of chronic obstructive pulmonary
•disease and/or chronic bronchitis.
•10. 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 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 8.3.5.2.; Note: Subjects with chronic, stable
•use of prophylactic treatment for recurrent herpes viral infection can be
•included in this study.
•11. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis
•B core antibody, [HBcAb], hepatitis C [HCV] antibody with positive HCV RNA, or
•human immunodeficiency virus [HIV] antibody) at the screening visit.
•Note: Subjects with a positive HBcAb and a negative HBsAg can be included if
•hepatitis B surface antibody is positive (considered immune after a natural
•infection). Subjects who are positive for HCV antibody and negative for HCV RNA
•may be enrolled.
•In the event of rescreening,

研究者

发起方

Galderma

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