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Efficacy Evaluation and Mechanistic Study of Stapokibart in the Treatment of Moderate-to-Severe Bullous Pemphigoid

Efficacy Evaluation and Mechanistic Study of Stapokibart in the Treatment of Moderate-to-Severe Bullous Pemphigoid

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124314
Enrollment
Unknown
Registered
2026-05-10
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Bullous pemphigoid

Interventions

Stapokibart Group:Stapokibart combined with oral glucocorticoids
Mycophenolate Mofetil Group:Mycophenolate Mofetil combined with oral glucocorticoids

Sponsors

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine (Wuhan First Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Patients who have been diagnosed with bullous pemphigoid; 3. Disease activity score (BPDAI) reaches moderate to severe level (>= 20); 4. Able to follow up as required by the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Active severe infection or other conditions deemed unsuitable by investigators. 2.Known hypersensitivity/contraindications to study-related medications. 3.Pregnancy or breastfeeding. 4.Recent participation in other interventional clinical studies or poor compliance. 5.Any other condition judged by investigators to make the participant ineligible.

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving clinical remission at Week 36;

Secondary

MeasureTime frame
Pruritus score;Cumulative glucocorticoid dose (prednisone equivalent);Incidence of adverse events;Time to disease control;Change from baseline in BPDAI score;Anti-epidermal basement membrane zone antigen 230;Anti-epidermal basement membrane zone antigen 180;

Countries

China

Contacts

Public ContactJinbo Chen

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine (Wuhan First Hospital)

chen999jb@163.com+86 27 85332176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026