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: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-001889-15-FR
- Lead Sponsor
- Galderma S.A.
- 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 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], 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 satisfy inclusion criteria 1a through 1c are permitted to enroll immediately into the LTE study, provided other eligibility criteria are met.
Subjects satisfying inclusion criterion 1d can be considered for eligibility after interim PK and safety analyses of data from SPR.116912 are conducted by the sponsor and an IDMC to determine whether enrollment of the adolescent age group (12-17 years) is safe. Following Independent Ethics Committees/Institutional Review Boards approval, the sponsor will send
a written communication to the site confirming that the study is open for enrollment of adolescents. Adolescents and/or subjects from SPR.116912 even if presently 18 years of age must not be enrolled in the study until such communication is received. 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 (
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 (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 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 < 30 kg;
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 1 week before the screening visit. Subjects may be rescreened once the infection has resolved;
11. Positive serology results (hepatitis B surface antigen or hepatitis B core antibody, hepatitis C 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 (plasma-derived or recombinant, eg, monoclonal antibody) 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 [Myco
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method