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

• Register: EUCTR
• Last refreshed on: 18 March 2020
• Main ID: EUCTR2015-000762-65-DE
• Date of registration: 25/06/2015
• Prospective Registration: Yes
• Primary sponsor: Technische Universität München, School of Medicine, represented by Dean
• Public title: Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosu
• Scientific title: Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosum
• Date of first enrolment: 09/07/2015
• Target sample size: 7
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000762-65
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Studienzentrum Dermatologie
• Affiliation: Department of Dermatology and Allergy Technische Universität München

• Name: Studienzentrum Dermatologie
• Affiliation: Department of Dermatology and Allergy Technische Universität München

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

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: 20.0 Level: PT Classification code 10037635 Term: Pyoderma gangrenosum System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

Trade Name: Cosentyx®
Product Name: Cosentyx
Product Code: EU/1/14/980/002; EU/1/14/980/003
Pharmaceutical Form: Solution and suspension for suspension for injection in pre-filled syringe

Primary Outcome(s)

Main Objective: To evaluate efficacy and tolerability of secukinumab in patients with pyoderma gangrenosum after 16 week treatment with 300 mg s.c. secukinumab.

Timepoint(s) of evaluation of this end point: Week 16

Primary end point(s): Change of the Physician's global assessment (Grade 0-4) of the target lesion

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): a) Change in surface area of lesions of pyoderma gangrenosum
b) Laboratory measurements
c) Patient's quality of life (measured by "dermatology life quality index, DLQI")
d) Immunohistochemical analysis of IL-17+ immune cells
e) Change of the Physician's global assessment (Grade 0-4) of the target lesion

Timepoint(s) of evaluation of this end point: a) Week 2, 4, 8, 16, 28, 32, 40
b) Week 2, 4, 8, 16, 28, 32, 40
c) Week 2, 4, 8, 16, 28, 32, 40
d) Week 16 as compared to week 0
e) Week 32

Secondary ID(s)

CAIN457ADE01T

Source(s) of Monetary Support

Novartis Pharmaceuticals AG

Ethics review

Status: Approved
Approval date: 01/07/2015
Contact: