No registrations found.
ID
Source
Brief title
Health condition
Pemphigoid
Pemfigioid
Sponsors and support
Intervention
Outcome measures
Primary outcome
Partial remission
Secondary outcome
Drug survival
Complete remission
Background summary
Pemphigoid is the most common chronic autoimmune disease of the skin and mucosae. It is often treated with systemic corticosteroids, which are associated with serious adverse effects. Therefore, there is a need for safer treatment options. In this pilot efficacy study the treatment response of apremilast combined with doxycycline in mild to moderate cutaneous pemphigoid of ten patients will be evaluated. The primary objective is partial remission, secondary objectives are drug survival and complete remission. Eligible patients will be recruited during routine clinical care in the department of Dermatology of the UMCG.
Study objective
Impairment of immune-complex-induced neutrophil activation caused by PDE4 inhibition, making it a potential target for the treatment of pemphigoid diseases.
Study design
Baseline and week 16
Intervention
Apremilast combined with doxycycline
Inclusion criteria
Adult patients with recently diagnosed mild to moderate localized or generalized cutaneous pemphigoid, or patients that were in complete remission without treatment that have a mild-moderate flare-up of the disease.
Exclusion criteria
Contradiction or known allergy for PDE4 inhibitors.
Women of childbearing potential without contraception, women who are pregnant or planning to become pregnant or who are lactating.
Patients that use systemic immunosuppressive medication
Any condition which would make the patient unsuitable for treatment, or requires steroid use.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7166 |
| NTR-old | NTR7388 |
| Other | Celgene : AP-CL-OTHER-PI-12868 |