Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07660835

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis

Conditions: Moderate-to-Severe Atopic Dermatitis

Sex: All
Ages: 6 Months – 23 Months
Healthy volunteers: No
Phase: PHASE2
Enrollment: 35
Sponsor: Galderma R&D

Location: Texas Dermatology and Laser Specialist-San Antonio San Antonio Texas

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.

Eligibility Criteria

Inclusion Criteria * Participants greater than and equal to (\>=) 6 to less than (\= 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 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. Exclusion Criteria * 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., \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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07660835). StuddyBuddy aggregates publicly available trial information.