Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China

NCT ID: NCT05680298

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-03-15

Brief Summary

This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and <12 years old), and a 12-week follow-up period. Patients will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 End of Treatment (EoT) phase visit, and every 6-weeks thereafter during the follow-up period and by this will end the study for each participant (End of Study [EoS]). The maximum duration of the study per participant will be 32 weeks (including screening period).

Skin barrier function in approximately 10 healthy volunteers (not more than 20 healthy participants aged ≥6 and <12 years old) matched for age (match on age ±2 years), gender, location of targeted lesion area, and study site to the AD cases will be assessed in a similar manner at baseline, and will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 EoT phase visit, and every 6-weeks thereafter during the follow-up period, serving as a reference comparator for skin barrier function.

Detailed Description

32 weeks

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD patients

Pediatric patients (≥6 and \<12 years of age) with moderate-to-severe AD will receive a SC injection of dupilumab depending on the body weight

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

solution for injection, Subcutaneous injection

Healthy volunteers

Except for IMPs administration, skin barrier function assessments for healthy volunteers are conducted at the same time and in the same measurement conditions as for AD patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dupilumab

solution for injection, Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Dupixent

Eligibility Criteria

Inclusion Criteria

• Participant must be between ≥6 to <12 years of age inclusive, at the time of signing the informed consent.
• Male or female.
• Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
• Investigator Global Assessment score of ≥3 (for US patients) or IGA ≥4 (for EU patients) at screening (on the 0 to 4 scale) depending on approved label indication in the country.
• Patients with moderate-to-severe AD are eligible to be treated with dupilumab according to product label.
• Patients with AD must have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0 to 3 scale of the ISS.
• Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible.
• Willing to refrain from applying any topical medications on the target assessment areas (including lesional and non-lesional) throughout the study until EoS unless necessary to alleviate intolerable symptoms.
• Willing to refrain from showers or soak in a bathtub with soaps and body washes within 6 hours before TEWL assessments.
• Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas (lesional and non-lesional) during the entire study from Day -7 to Week 28 (EoS).
• Willing and able to comply with all clinic visits and study-related procedures.
• 15 kg ≤ body weight <60 kg

• Age and gender matched (match on age ±2 years) to a selected AD patient by study site.
• No current dermatologic or systemic condition that could interfere with the assessments.
• 15 kg ≤ body weight <60 kg
• Male or female - - - -

Exclusion Criteria

Medical conditions

• Previous treatment with dupilumab within 6 months prior to screening.
• Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis).
• Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments.
• Hypersensitivity to the active substance or to any of the excipients of dupilumab.
• Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation.
• Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors or phototherapy within 4 weeks of baseline.
• Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the Investigator.
• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
• History of hypersensitivity reaction to tape or adhesives used in desquamme discs.
• Patients administered live attenuated vaccines within the 4 weeks prior to the baseline visit or need to receive live (attenuated) vaccinations through Week 28.

Prior/concomitant therapy

• Treatment with an investigational medication within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer.
• Patients who received a live vaccine within 4 weeks of baseline.

Prior/concurrent clinical study experience

• Current participation in another investigational or interventional clinical study

Other exclusions

• Planned or anticipated major surgical procedure during the patient's participation in this study.
• Healthy volunteers with a personal history of an atopic condition.
• Healthy volunteers with use of any topical treatment anywhere except Cetaphil®, Vanicream™, E45 cream or the preferred moisturizer not containing additives on non-targeted skin areas.
• Female of childbearing potential* and sexually active, who is unwilling to use highly effective methods of contraception prior to the initial dose, during the study and for at least 120 days after the last dose of study drug.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Beijing Children's hospital

Beijing, , China

Countries

China

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25296&tenant=MT_SNY_9011

LPS17244 Plain language Results Summary

Other Identifiers

U1111-1272-6639

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-000402-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LPS17244

Identifier Type: -

Identifier Source: org_study_id