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A clinical study to evaluate the effectiveness and safety of Dupilumab injection (Dupixent ?R) in the treatment of mild to moderate bullous pemphigoid

A clinical study to evaluate the effectiveness and safety of Dupilumab injection (Dupixent ?R) in the treatment of mild to moderate bullous pemphigoid

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058412
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-28
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Bullous Pemphigoid, BP

Interventions

Experimental group:Dupilumab

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, no gender restriction; 2. According to "Expert Recommendations for the Diagnosis and Treatment of Bullous Pemphigoid" (Autoimmune Disease Sub-specialty Committee of the Dermatologist Branch of the Chinese Medical Doctor Association in 2016)" clinical diagnosis of bullous pemphigoid (requires histopathology) Supported by examination, direct immunofluorescence and pemphigoid antibody results); 3. Severity grade: graded according to the affected area of the body surface as mild (<10%) or moderate (10-50%); 4. Local single topical drug treatment and systemic use of hormones or immunosuppressive agents are not effective, and the symptoms are persistent or repeated; 5. Before the start of the study, fully listen to the explanation of the purpose and content of the experiment, and voluntarily sign a written consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with tumor or immunodeficiency disease; 2. Combined with other autoimmune diseases; 3. Combined with other serious system diseases; 4. Women during pregnancy or lactation; 5. Patients who have used immunosuppressive agents (except glucocorticoids) in the past 4 weeks; 6. Patients who have been treated with glucocorticoids continuously in the past 2 weeks and the dose has reached or exceeded 0.5mg/kg/d; 7. Patients who have used other biological agents (such as rituximab, omalizumab, etc.) in the past 4 weeks; 8. There are other situations that the researcher thinks should not be included in this study.

Design outcomes

Primary

MeasureTime frame
Skin lesion area involvement score;The proportion of pruritus NRS severity score decreased from baseline;

Secondary

MeasureTime frame
Peripheral blood eosinophil level;Total IgE level;BP180 and BP230 antibody levels;

Countries

China

Contacts

Public ContactGang Wang

Xijing Hospital

xjwgang@fmmu.edu.cn+86 13609261631

Outcome results

None listed

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