Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Mod… (NCT07660835) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis
35 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
6 Months – 23 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 post…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Observed Nemolizumab Serum Concentrations
Timeframe: Predose at Weeks 4, 16, 32 and 52
2
Total Body Clearance For Extravascular Administration (Cl/F) of Nemolizumab
Timeframe: Predose at Weeks 4, 16, 32 and 52
3
Apparent Volume of Distribution for Extravascular Administration (Vd/F) of Nemolizumab
Timeframe: Predose at Weeks 4, 16, 32 and 52
4
First-Order Absorption Rate Constant (ka) of Nemolizumab
Timeframe: Predose at Weeks 4, 16, 32 and 52
5
Area Under the Concentration-Time Curve Across Time (From Zero to Infinity) (AUCinf)) of Nemolizumab
Timeframe: Predose at Weeks 4, 16, 32 and 52
6
Terminal Half-Life (t1/2) of Nemolizumab
Timeframe: Predose at Weeks 4, 16, 32 and 52
7
Trough Serum Concentration at Each Specified Time Point (predicted Ctrough) of Nemolizumab
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)