ong-term study to assess the safety and efficacy of Nemolizumab in subjects with Atopic Dermatitis
- Conditions
- Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
- Registration Number
- EUCTR2019-001889-15-IT
- Lead Sponsor
- Galderma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1300
1. 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 qualifyfor 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], and SPR.114322 [Week 24]), unless the subject experienced an AE that may present an unreasonable risk if study medication is continued;
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 enroll within 28 days of completing the final visit of a lead-in study may use final
study assessments for the screening visit, unless the subject prematurely discontinued study drug in the lead-in study. All other subjects should complete a separate screening visit within 28 days before the first dose of study medication in the LTE.
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 must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection or to use an effective 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.
Effective and approved methods of contraception applicable for the subject and/or her partner are defined below:
• Progestogen-only oral hormonal contraception;
• Male or female condom;
• Cap, diaphragm, or sponge with spermicide;
• Combination of male or female condom with cap, diaphragm, or sponge with spermicide;
• Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception;
• Injectable or implanted hormonal contraception;
• Intrauterine devices;
• Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study;
• 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;
• Documented hysterectomy or bilateral oophorectomy at least 3 months before screening.
5. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol;
6. Understand and sign
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.Having received any of the treatments listed in Table 6 of the protocol within the specified timeframe before the baseline visit;
3.Pregnant women,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;
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 subjects who do not rollover from a prior nemolizumab study within 28 days of completing final study assessments or who discontinued study drug before completing the
treatment period during the lead-in study:
7.Body weight <30kg;
8.Subjects with a history of asthma meeting 1 or more of the following criteria:
8a.Had an asthma exacerbation requiring hospitalization in the preceding 12 months;
8b.Reporting asthma that has been not well controlled (ie,symptoms>2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the preceding 3 months;
8c. Asthma Control Test(ACT)=19;
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 screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1week before the
screening visit. Subjects may be rescreened once the infection has resolved;
11.Positive serology results(hepatitisB surface antigen or hepatitisB core antibody,hepatitisC antibody,or human immunodeficiency virus antibody)at the screening visit;
12.Subjects who failed to respond clinically to previous treatment with a biologic(eg, dupilumab)or a Janus kinase inhibitor;
13.History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for basal cell carcinoma,squamous cell carcinoma in situ (Bowen's disease),actinic keratoses,or carcinoma in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit;
14.History of hypersensitivity(including anaphylaxis)to an immunoglobulin product or to any of the study drug excipients;
15.History of intolerance to TCS or for whom TCS is not advisable(eg,hypersensitivity to TCS,significant skin atrophy,etc),unless TCS was not used as background therapy in the lead-in study;
16.Known active or latent tuberculosis infection;
17.Known or suspected immunosuppression or unusually frequent,recurrent,severe,or prolonged infections as per investigator judgment;
18.History of or current confounding skin condition (eg,Netherton Syndrome,psoriasis,cutaneous T-cell lymphoma,contact dermatitis,chronic actinic dermatitis,dermatitis herpetiformis);
19.Any clinically relevant lab.abnormalities, such as but not limited to elevated ALT or AST(>3× upper limit of normal) in combination with elevated bilirubin(>2× upper limit of
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<br>(CD14152) in adult and adolescent subjects with moderate-to-severe<br>atopic dermatitis (AD).;Secondary Objective: The secondary objective is to assess the long-term efficacy of<br>Nemolizumab (CD14152) in adult and adolescent subjects with<br>moderate-to-severe AD;Primary end point(s): Safety Endpoints:<br>- Incidence and severity of treatment-emergent AEs throughout the<br>study<br>- Incidence of serious treatment-emergent AEs throughout the study<br>- Incidence and severity of AEs of special interest (AESIs);Timepoint(s) of evaluation of this end point: Safety Endpoints: throughout the study
- Secondary Outcome Measures
Name Time Method