A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis.
- Conditions
- atopic dermatitischronic skin inflammation10014982
- Registration Number
- NL-OMON54779
- Lead Sponsor
- Galderma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
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;
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(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
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.
Adequate and approved meth
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
subject.
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
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 (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
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.
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.; 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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Endpoints:<br /><br>- Incidence and severity of treatment-emergent AEs throughout the study<br /><br>- Incidence of serious treatment-emergent AEs throughout the study<br /><br>- Incidence and severity of AEs of special interest (AESIs) throughout the<br /><br>study</p><br>
- Secondary Outcome Measures
Name Time Method