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

Primary Purpose

Pyoderma Gangrenosum

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Technical University of Munich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label

Arm Description

300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
Assessment of patient's quality of life
Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
Measurement of serum C reactive protein (mg/dl)
Measurement of leukocyte counts (x10.e3/µl)
Measurement of blood sedimentation rate (mm/h)
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.

Full Information

First Posted
March 28, 2016
Last Updated
April 11, 2023
Sponsor
Technical University of Munich
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02733094
Brief Title
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Official Title
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label
Arm Type
Experimental
Arm Description
300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Primary Outcome Measure Information:
Title
Change of the Physician's global assessment
Description
The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
Time Frame
Week 2,3,8,16,28,40
Title
Assessment of patient's quality of life
Description
Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
Time Frame
Week 2, 4, 8, 16, 28, 40
Title
Measurement of serum C reactive protein (mg/dl)
Time Frame
Week 2, 4, 8, 16, 28, 40
Title
Measurement of leukocyte counts (x10.e3/µl)
Time Frame
Week 2, 4, 8, 16, 28, 40
Title
Measurement of blood sedimentation rate (mm/h)
Time Frame
Week 2, 4, 8, 16, 28, 40
Title
Immunohistochemical analysis of IL-17+ immune cells
Description
The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kilian Eyerich, MD, PhD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University of Munich
City
Munich
ZIP/Postal Code
80802
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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