Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT04117932
• Date of registration: 04/10/2019
• Prospective Registration: Yes
• Primary sponsor: CHU de Reims
• Public title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid PB-USTE
• Scientific title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
• Date of first enrolment: March 11, 2020
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04117932
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion criteria

inclusion criteria :

- patient with bullous pemphigoid

- patient aged between 18 and 90

- patient with Karnofsky Performance score > 60%

- patient agreed to participate to the study

exclusion criteria :

- patient with allergy to corticosteroids

- patient with allergy to ustekinumab

- patient with any severe medical condition at time of inclusion including stroke, heart
failure, renal failure, high blood pressure and diabetes mellitus

- malignancy < 5 years prior to inclusion

- pregnant or nursing (lactating) women, or women of child-bearing potential

- active infection or with recent history of clinically significant infection within 4
weeks prior to inclusion

- history or presence of infection with hepatitis B or C.

- history or presence of immunodeficiency diseases, including a positive HIV (ELISA and
Western blot) test result.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bullous Pemphigoid

Intervention(s)

Drug: Ustekinumab

Primary Outcome(s)

complete remission [Time Frame: 28 weeks]

Secondary ID(s)

PO19083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors