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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-525027-27-00 | Other Identifier | EU CT Number |
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The primary objective of the study is to assess the pharmacokinetics (PK) and safety of nemolizumab in pediatric participants (aged 6-23 months) with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical treatments.
Participants will be screened up to 4 weeks prior to the Baseline visit. At Baseline/Day 1, all participants will receive a loading dose of nemolizumab high dose administered subcutaneously (SC), followed by nemolizumab low dose SC every 4 weeks (Q4W) during the 52-week treatment period, with the final study treatment administered at Week 48.
After completion of the 52-week treatment period, participants will enter an 8-week safety follow-up period through Week 60. Participants who prematurely discontinue the study before the Week 48 visit will be followed for 12 weeks after their last administration of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab | Experimental | Participants aged 6 to 23 months will receive a subcutaneous (SC) loading dose of nemolizumab high dose on Baseline/Day 1 followed by nemolizumab low dose SC once every 4 weeks (Q4W) for up to 52 weeks (last dose at 48 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemolizumab | Drug | A lyophilized powder for solution for SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed Nemolizumab Serum Concentrations | Predose at Weeks 4, 16, 32 and 52 | |
| Total Body Clearance For Extravascular Administration (Cl/F) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| Apparent Volume of Distribution for Extravascular Administration (Vd/F) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| First-Order Absorption Rate Constant (ka) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| Area Under the Concentration-Time Curve Across Time (From Zero to Infinity) (AUCinf)) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| Terminal Half-Life (t1/2) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| Trough Serum Concentration at Each Specified Time Point (predicted Ctrough) of Nemolizumab | Predose at Weeks 4, 16, 32 and 52 | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs) | Baseline up to Week 60 |
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Inclusion Criteria
Participants greater than and equal to (>=) 6 to less than (<) 24 months of age at the screening visit.
Diagnosis of AD according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit.
Eczema Area and Severity Index (EASI) score >= 16 at both screening and baseline visits.
Investigator's Global Assessment (IGA) score >= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both screening and baseline visits.
AD involvement >= 10 percent (%) of body surface area (BSA) at both screening and baseline visits. (Note: BSA to be derived from the SCORing Atopic Dermatitis (SCORAD).)
Weekly average of worst scratch/itch Numeric Rating Scale (WSI-NRS) score of at least 4 at both screening and baseline visits as assessed by the parent(s)/caregiver:
Documented history by a physician and/or investigator of inadequate response to existing topical AD medications or use of systemic therapies for control of the disease (within 6 months before the screening visit).
Participant's parent(s)/caregiver willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.
Participant's parent(s)/caregiver understand and sign a parental Informed Consent Form (ICF) before any study-related procedures are performed.
Participant's parent(s)/caregiver agree to apply a moisturizer daily from the screening visit and liberally as needed throughout the study; if applying a prescribed topical corticosteroid (TCS) prior to study enrollment, agree to continue at the same stable dose from screening and throughout the study as determined appropriate by the investigator.
Exclusion Criteria
Coal tar products - 2 weeks Topical Janus kinase (JAK) inhibitor - 2 weeks Topical phosphodiesterase-4 (PDE-4) inhibitor - 2 weeks Medium and higher potency TCS - 2 weeks Topical calcineurin inhibitor (TCI) - 2 weeks Topical medications with occlusive dressings (e.g., wet wraps) - 2 weeks Systemic corticosteroids (inhaled and intraocular permitted) - 4 weeks Immunosuppressive or immunomodulatory drugs (e.g., cyclosporine A, oral tacrolimus, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, JAK inhibitors) - 4 weeks or 5 half-lives (whichever is longer) Biologics and biosimilars (e.g., etanercept, adalimumab, infliximab, omalizumab) - 8 weeks or 5 half-lives (whichever is longer) Dupilumab - 10 weeks Live (attenuated) vaccine - 4 weeks Alternative medicine for AD (e.g., traditional Chinese medicine) - 2 weeks For participants with planned live (attenuated) vaccination during the study, consultation with a pediatrician will determine whether vaccination should be postponed until study completion or administered before study start without compromising health. Inactivated vaccines (e.g., diphtheria, tetanus, pertussis (DPT), hepatitis A, hepatitis B, inactivated polio vaccine (IPV), haemophilus influenzae type B, meningococcal, pneumococcal, influenza) are permitted.
Uncontrolled asthma defined as one or more of the following:
Asthma exacerbation requiring hospitalization since birth (<=12 months of age) or within the preceding 12 months (>12 months of age)
Daytime asthma symptoms >2 times per week during the preceding 3 months
Nighttime awakenings >2 times per month during the preceding 3 months
Asthma exacerbation requiring oral corticosteroids or additional Short-Acting
Beta-Agonist (SABA) inhalers >2 times per week during the preceding 3 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research and Development | Contact | 1-817-961-5000 | clinical.studies@galderma.com |
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| ID | Term |
|---|---|
| C000612881 | nemolizumab |
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