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

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal

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