A Phase 4, multicenter study to evaluate pharmacokinetics, safety and effectiveness of dupilumab in Chinese participants aged =6 years to <18 years with moderate-tosevere atopic dermatitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300073738

Enrollment

Unknown

Registered

2023-07-19

Start date

2023-08-25

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis

Interventions

dupilumab:None

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Enrolled in Study OBS17243. Signed informed consent by the parent/legally authorized representative and assent by the participants appropriate to the participants’ age. Assent will be collected from participants as per China law and regulation.

Exclusion criteria

Exclusion criteria: None.

Design outcomes

Primary

Measure	Time frame
Trough concentration of dupilumab in serum over time;	—

Secondary

Measure	Time frame
Number of participants with Adverse Events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation, and AEs leading to death;Proportion of participants with a vIGA score of 0 to 1 (on a 5-point scale) at Week 16;Proportion of participants with EASI-75 (=75% improvement from baseline) at Week 16;Percent change from baseline to Week 16 in Pruritus NRS for participants aged =6 years to <18 years;	—

Measure

Time frame

Number of participants with Adverse Events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation, and AEs leading to death;Proportion of participants with a vIGA score of 0 to 1 (on a 5-point scale) at Week 16;Proportion of participants with EASI-75 (=75% improvement from baseline) at Week 16;Percent change from baseline to Week 16 in Pruritus NRS for participants aged =6 years to <18 years;

—

Countries

China

Contacts

Public ContactHua Wang

Children's hospital of Chongqing Medical University

huawang63@hotmail.com+86 151 2338 0348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026