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-DE
- 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
- 1749
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], 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).
Note: 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 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 received.
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. If a subject has reached Tanner stage 3 breast development, even if not having menarche, the subject will be considered a female of child bearing potential.
Adequate and approved methods of contraception applicable for the
subject and/or her partner are defined below:
- Progestogen-only oral hormonal contraception;
- Combined (estrogen- and progestogen-containing) oral, intravaginal, or t
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 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 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;
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 (PEF) < 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 screening.
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 carcinoma in situ (Bowen's disease), 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, or
2) actinic keratoses that have been treated;
14. History of hypersensitivity (includin
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