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Efficacy and safety of upadacitinib in patients over 12 years old with moderate to severe atopic dermatitis after poor response to dupilumab

Efficacy and safety of upadacitinib in patients over 12 years old with moderate to severe atopic dermatitis after poor response to dupilumab

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066260
Enrollment
Unknown
Registered
2022-11-29
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

atopic dermatitis

Interventions

Moderate to severe atopic dermatitis group:no intervention

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)Male or female aged between12-75, >=40Kg, meeting the Hanifin-Rajka criteria for diagnosis of atopic dermatitis, with atopic dermatitis symptoms >=3 years (2)EASI>=16 and weekly mean WP-NRS>=4 (3)The patient didn't reach EASI 90 or whose weekly mean WP-NRS deceased<4 from baseline after 16 weeks of Dupilumab treatment (4)Dermatologists suggest further treatment with upadacitinib based on the patient's signs and symptoms. (5)The informed content is signed by the patient.

Exclusion criteria

Exclusion criteria: (1) The patient is suffering from other skin diseases which will interfere with the assessment of efficacy (2) The patient is allergic to upadacitinib. (3) The patient is suffering from active tuberculosis or active severe infections. (4) The patient is suffering from severe liver function impairment. (5) The patient is suffering from malignant tumor or had a history of malignant tumor within 5 years (except cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma without metastasis). (6) Pregnancy or lactation (7) The patient is excluded in the study due to other diseases, which is evaluated by researchers.

Design outcomes

Primary

MeasureTime frame
The proportion of patients who reach EASI 75 and EASI 90;

Secondary

MeasureTime frame
The proportion of patients who reach EASI 75 and EASI 90;The proportion of patients whose weekly mean WP-NRS deceased=4 from baseline;The proportion of patients whose DLQI deceased >=4 from baseline;

Countries

China

Contacts

Public ContactCuihong Lian

Shenzhen Second People's Hospital

liancuihong@email.szu.edu.cn+86 15814692161

Outcome results

None listed

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