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

Phase 1

• 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.; MedDRA version: 20.0Level: PTClassification code 10037635Term: Pyoderma gangrenosumSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-000762-65-DE
• Lead Sponsor: Technische Universität München, School of Medicine, represented by Dean

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-25
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy and tolerability of secukinumab in patients with pyoderma gangrenosum after 16 week treatment with 300 mg s.c. secukinumab.;Secondary Objective: Not applicable;Primary end point(s): Change of the Physician's global assessment (Grade 0-4) of the target lesion;Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Change in surface area of lesions of pyoderma gangrenosum <br>b) Laboratory measurements <br>c) Patient's quality of life (measured by dermatology life quality index, DLQI)<br>d) Immunohistochemical analysis of IL-17+ immune cells <br>e) Change of the Physician's global assessment (Grade 0-4) of the target lesion<br>;Timepoint(s) of evaluation of this end point: a) Week 2, 4, 8, 16, 28, 32, 40<br>b) Week 2, 4, 8, 16, 28, 32, 40<br>c) Week 2, 4, 8, 16, 28, 32, 40 <br>d) Week 16 as compared to week 0<br>e) Week 32