ong-term study to assess the safety and efficacy of Nemolizumab in subjects with Atopic Dermatitis
- Conditions
- Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-001889-15-HU
- Lead Sponsor
- Galderma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1749
To be eligible for study entry, subjects must satisfy all of the following criteria:
1. Adolescent subjects (aged 12-17) who have not participated in a previous nemolizumab study (selected countries/selected sites) 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;
OR
b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169);
OR
c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 vaccination safety study (SPR.118380);
OR
d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 adolescent PK/safety study (SPR.116912);
OR
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;
OR
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;
OR
g. Subjects who completed the treatment period (Week 16) in the Phase 3b study (SPR.201591);
OR
h. Subjects who completed the treatment period (Week 13) in the Phase 2 DDI study (SPR.201593)
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 the study.
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);
- 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
4. 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 sal
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;
In Czech Republic only, 1 is revised:
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.
Subjects who experienced
• worsening or recurrence of asthma
• recurrent or severe infections
during the lead-in study where continued exposure to study drug would pose unacceptable risk to the subject.
2. Having received any of the treatments listed in Table 10 of the protocol 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 study;
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 study;
6. Subjects unwilling to refrain from using prohibited medications during the clinical study;
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 in the lead-in study:
7. Body weight < 30 kg;
In Czech Republic only, 7 applies to all subjects.
8. Subjects meeting 1 or more of the following criteria at screening or baseline:
8a. Had an asthma exacerbation requiring hospitalization in the preceding 12 months;
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.
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.;
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;
12. 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 IGA);
13. 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 carci
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the long-term safety of Nemolizumab (CD14152) in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: The secondary objective is to assess the long-term efficacy of Nemolizumab (CD14152) in adult and adolescent subjects with moderate-to-severe AD;Primary end point(s): Safety Endpoints:<br>- Incidence and severity of treatment-emergent AEs throughout the study<br>- Incidence of serious treatment-emergent AEs throughout the study<br>- Incidence and severity of AEs of special interest (AESIs) throughout the study<br>;Timepoint(s) of evaluation of this end point: Safety Endpoints: throughout the study<br><br><br>
- Secondary Outcome Measures
Name Time Method