Moderate-to-Severe Atopic DermatitisPhase 2NemoBabyNCT07660835
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis
A Phase 2 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Moderate-to-Severe Atopic Dermatitis
- What is being tested?
- Nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 15 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- Screening WSI-NRS score will be determined by a single WSI-NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.
- Baseline WSI-NRS score will be determined based on the average of daily WSI-NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned enrollment date, enrollment should be postponed until this requirement is met, without exceeding the maximum screening duration of 4 weeks.
- 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.
Who cannot join
- Body weight < 5 Kilograms (kg).
- Child in Care: a child placed under the control or protection of an agency, organization, institution, or entity by courts or government authorities under applicable law or regulation.
- Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit. Participants may be rescreened once the infection has resolved.Note: A participant with mild, localized superficial infection may be included based on investigator discretion.
- Having received any of the following treatments within the specified timeframe before the baseline visit:
- 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.
- Participants who, after a full 16-week treatment course with dupilumab, experienced worsening of AD or failed to achieve minimal improvement (e.g., <= 10% reduction in EASI or no reduction in IGA).
Show all 20Show fewer
- History of lymphoproliferative disease or malignancy of any organ system before the screening visit.
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or any study treatment excipients.
- Known or suspected primary immunodeficiency.
- History of, or current confounding skin condition (e.g., Netherton syndrome, psoriasis, contact dermatitis, dermatitis herpetiformis, erythroderma, ichthyosis, scabies) that may interfere with study assessments.
- Any medical condition (e.g., serious cardiac, hepatic, pulmonary [including uncontrolled asthma], or hematologic disease) or clinically relevant laboratory abnormality during screening that may place the participant at significant risk or interfere with study assessments (e.g., poor venous access or needle phobia). Note: Laboratory tests with abnormal results may be repeated once during screening; the last value will determine eligibility.
- 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
- Planned or expected major surgical procedure during the clinical study.
- Planned or anticipated use of prohibited medications during the study.
- Currently participating or participated in another clinical study of an investigational drug or device within the past 8 weeks (or 5 half-lives, whichever is longer) before the screening visit, or currently in an exclusion period from a previous clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Dermatology and Laser Specialist-San Antonio
San Antonio, Texas, 78218
About this study
Official title: A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy
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.
Read the detailed description
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.
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Being tested
- Nemolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemolizumabDrug
Also called CD14152
A lyophilized powder for solution for SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nemolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Nemolizumab Serum Concentrations
Measured: Predose at Weeks 4, 16, 32 and 52
Total Body Clearance For Extravascular Administration (Cl/F) of Nemolizumab
Measured: Predose at Weeks 4, 16, 32 and 52
Apparent Volume of Distribution for Extravascular Administration (Vd/F) of Nemolizumab
Measured: Predose at Weeks 4, 16, 32 and 52
First-Order Absorption Rate Constant (ka) of Nemolizumab
Measured: Predose at Weeks 4, 16, 32 and 52
Area Under the Concentration-Time Curve Across Time (From Zero to Infinity) (AUCinf)) of Nemolizumab
Measured: Predose at Weeks 4, 16, 32 and 52
Terminal Half-Life (t1/2) of Nemolizumab
Measured: Predose at Weeks 4, 16, 32 and 52
Trough Serum Concentration at Each Specified Time Point (predicted Ctrough) of Nemolizumab
Measured: 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)
Measured: Baseline up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start13 Jul 2026
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-Severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660835
- Sponsor's protocol ID
- SPR.118130
- Other IDs
- 2025-525027-27-00, 2025
- Acronym
- NemoBaby
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy
- ClinicalTrials.gov ID
- NCT07660835
- Acronym / sponsor ID
- NemoBaby / SPR.118130
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab | Experimental | Drug: NemolizumabParticipants 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). |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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).)
Key exclusion criteria (20 listed)
- Body weight < 5 Kilograms (kg).
- Child in Care: a child placed under the control or protection of an agency, organization, institution, or entity by courts or government authorities under applicable law or regulation.
- Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit. Participants may be rescreened once the infection has resolved.Note: A participant with mild, localized superficial infection may be included based on investigator discretion.
- Having received any of the following treatments within the specified timeframe before the baseline visit:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NemolizumabAlso: CD14152A lyophilized powder for solution for SC injection. | Drug | Nemolizumab |
Primary outcome
Observed Nemolizumab Serum Concentrations
Time frame: Predose at Weeks 4, 16, 32 and 52
Total Body Clearance For Extravascular Administration (Cl/F) of Nemolizumab
Time frame: Predose at Weeks 4, 16, 32 and 52
Apparent Volume of Distribution for Extravascular Administration (Vd/F) of Nemolizumab
Time frame: Predose at Weeks 4, 16, 32 and 52
First-Order Absorption Rate Constant (ka) of Nemolizumab
Time frame: Predose at Weeks 4, 16, 32 and 52
Area Under the Concentration-Time Curve Across Time (From Zero to Infinity) (AUCinf)) of Nemolizumab
Time frame: Predose at Weeks 4, 16, 32 and 52
Terminal Half-Life (t1/2) of Nemolizumab
Time frame: Predose at Weeks 4, 16, 32 and 52
Trough Serum Concentration at Each Specified Time Point (predicted Ctrough) of Nemolizumab
Time frame: 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)
Time frame: Baseline up to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Moderate-to-Severe Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galderma Research and Development (1-817-961-5000, clinical.studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Nemolizumab Serum Concentrations (time frame: Predose at Weeks 4, 16, 32 and 52). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.