Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum

Technical University of Munich

Status and phase

Completed

Phase 2

Phase 1

Conditions

Pyoderma Gangrenosum

Treatments

Drug: Secukinumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02733094

CAIN547ADE01T

Details and patient eligibility

About

The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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)
- 18-75 years of age
- Body weight ≥ 40 kg and ≤ 160 kg
- Signed informed consent
Key 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
- Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin