Phase 2
N=109
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
Moderate-to-Severe Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04921345 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Nemolizumab Serum Concentrations — 5950; 2900; 3080; 5150 nanograms per milliliters (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nemolizumab (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nemolizumab Serum Concentrations |
5950; 2900; 3080; 5150; 2800; 2560 | — |
| PRIMARY Apparent Total Body Clearance (Cl/F) of Nemolizumab |
0.139; 0.134; 0.0761 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) of Nemolizumab |
3.39; 3.37; 1.75 | — |
| PRIMARY Absorption Rate Constant (Ka) of Nemolizumab |
0.502; 0.503; 0.494 | — |
| PRIMARY Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab |
6.71; 3.25; 3.13; 6.38; 3.15; 3.20 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab |
204; 101; 93.2 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of Nemolizumab |
17.7; 17.8; 16.9 | — |
| PRIMARY 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) |
30; 32; 32; 4; 3; 1 | — |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 |
-48.91; -66.10; -68.88; -61.40; -74.65; -75.41 | — |
| SECONDARY Absolute Change From Baseline in EASI Score |
-12.86; -18.90; -17.72; -16.56; -20.87; -19.51 | — |
| SECONDARY Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90) |
19; 25; 29; 10; 18; 21 | — |
| SECONDARY Number of Participants With Investigator's Global Assessment (IGA) Success Rate |
5; 12; 10; 9; 17; 14 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) |
-12.76; -22.22; -17.66; -17.75; -28.34; -23.09 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score |
-2.78; -3.03; -4.36; -3.91; -4.29; -4.84 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of PP NRS Score |
-38.15; -41.48; -57.89; -53.41; -58.95; -65.90 | — |
| SECONDARY Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS |
23.5; 31.4; 69.4; 44.4; 64.7; 66.7 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score |
-2.46; -2.84; -4.26; -3.61; -4.14; -4.64 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score |
-38.07; -42.77; -60.43; -55.69; -62.42; -66.94 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score |
-2.22; -2.87; -4.49; -3.22; -4.04; -4.91 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score |
-39.21; -42.47; -62.43; -56.84; -62.31; -70.03 | — |
| SECONDARY Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment |
13.9; 2.7; 5.6 | — |
| SECONDARY Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score |
-35.91; -49.08; -55.04; -50.33; -59.01; -61.09 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age |
-9.78; -10.80; -10.52; -10.72; -11.97; -12.00 | — |
| SECONDARY Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age |
-13.00; -13.27 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) |
-12.31; -13.71; -12.09; -13.31; -14.77; -15.53 | — |
| SECONDARY Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS |
0.719 | — |
| SECONDARY PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score |
4.58 | — |
| SECONDARY PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score |
0.09160 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab |
2; 0; 0; 3; 0; 0 | — |
Summary
The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion Criteria
- Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
- EASI score >=16 at both screening and baseline visits
- IGA score >=3 at both screening and baseline visits
- AD involvement >=10% of BSA at both screening and baseline visits
- Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
- Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
- Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Body weight less than 10 kilogram (kg)
- Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
- Participants with a current medical history of chronic bronchitis
- Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
- Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction [PCR]), or human immunodeficiency virus (HIV) antibody at the screening visit
- History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
- Known or suspected immunosuppression
- Participants unwilling to refrain from using prohibited medications during the clinical trial.
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT04921345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.