Moderate-to-Severe Atopic Dermatitis study: Nemolizumab
Official title Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07660835
What this study is testing
What is Nemolizumab?
an investigational subcutaneous injectable medicine being studied for moderate-to-severe atopic dermatitis in young children is designed to block the interleukin‑31 receptor, which may reduce itch and inflammation
Also referred to as CD14152.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing how a new medicine works in the body. It also checks if the medicine is safe for babies.
- Who it's for
- You may be able to join if your baby is 6 to 23 months old. Your baby must have a severe skin rash that does not get better with cream.
- What's involved
- Your baby would get the new medicine. The team would check how it moves through the body. They would also watch for any side effects.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 23
You may be able to join if
- 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...
- AD involvement \>= 10 percent (%) of body surface area (BSA) at both screening and baseline visits.
You likely can't join if
- 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...
- Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals...
- Having received any of the following treatments within the specified timeframe before the baseline visit: Coal tar products - 2 weeks Topical Janus...
- Participants who, after a full 16-week treatment course with dupilumab, experienced worsening of AD or failed to achieve minimal improvement (e.g...
- History of lymphoproliferative disease or malignancy of any organ system before the screening visit.
See the full eligibility 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).)
- 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).
- 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
- 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.
- 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)...
- 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).
- 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.
- Asthma exacerbation requiring hospitalization since birth (\ 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 23 months. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.