Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosum

Technische Universität München, School of Medicine, represented by Dean0 sites7 target enrollmentJune 25, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pyoderma gangrenosum is an autoinflammatory disease, characterized by relapsing, painful ulcers of the skin. Treatment of PG is difficult. Patients suffer from long hospitalization, pain and reduced life quality. New therapeutic strategies are needed. Immunohistological staining show a high amount of IL-17 in PG. IL-17+ immune cells were located in proximity to cellular damage, indicating an involvement in the pathogenesis. Targeting IL-17 with neutralizing IL-17 antibodies seems promising.
Sponsor: Technische Universität München, School of Medicine, represented by Dean
Enrollment: 7
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

June 25, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Technische Universität München, School of Medicine, represented by Dean

•Confirmed diagnosis of pyoderma gangrenosum, biopsy\-proven, non\-healing ulcer with primarily neutrophil infiltration, regardless of size and location, characterization of target lesion (size, PGA, duration, age 18\-75 years of age, body weight \= 40 kg and \= 160 kg, signed informed consent from patient, the first two patients of the trial must have received one other treatment for pyoderma gangrenosum before being included.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 7
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Permanent severe diseases, especially those affecting the immune system, pregnancy or breast feeding, history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia, myocardial infarction or cardiac arrhythmia which requires drug therapy, evidence of severe renal dysfunction or significant hepatic disease, history of irritable bowel disease, history of lymphoproliferative disorders, simultaneous participation in another clinical trial or participation in another clinical trial during the last 6 months.