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

Pyoderma Gangrenosum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733094
• Other study ID #: CAIN547ADE01T
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2016
• Est. completion date: September 19, 2019

Study information

• Verified date: February 2020
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 19, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• Secukinumab

Locations

Country	Name	City	State
Germany	Technical University of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Physician's global assessment	The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.	Week 16
Secondary	Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)		Week 2,3,8,16,28,40
Secondary	Assessment of patient's quality of life	Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.	Week 2, 4, 8, 16, 28, 40
Secondary	Measurement of serum C reactive protein (mg/dl)		Week 2, 4, 8, 16, 28, 40
Secondary	Measurement of leukocyte counts (x10.e3/µl)		Week 2, 4, 8, 16, 28, 40
Secondary	Measurement of blood sedimentation rate (mm/h)		Week 2, 4, 8, 16, 28, 40
Secondary	Immunohistochemical analysis of IL-17+ immune cells	The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.	Week 16