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

Phase 1

Completed

• Conditions: Pyoderma Gangrenosum
• Interventions: Drug: Secukinumab

• Registration Number: NCT02733094
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-28
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-19
• Status Verified: 2020-02
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label	Secukinumab	300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.

Primary Outcome Measures

Name	Time	Method
Change of the Physician's global assessment	Week 16	The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.

Secondary Outcome Measures

Name	Time	Method
Measurement of blood sedimentation rate (mm/h)	Week 2, 4, 8, 16, 28, 40
Assessment of patient's quality of life	Week 2, 4, 8, 16, 28, 40	Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
Measurement of serum C reactive protein (mg/dl)	Week 2, 4, 8, 16, 28, 40
Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)	Week 2,3,8,16,28,40
Measurement of leukocyte counts (x10.e3/µl)	Week 2, 4, 8, 16, 28, 40
Immunohistochemical analysis of IL-17+ immune cells	Week 16	The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.

Trial Locations

Locations (1)

Technical University of Munich; 🇩🇪 Munich, Germany