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

April 11, 2023 updated by: Technical University of Munich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80802
        • Technical University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label
300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.
Drug: Secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Physician's global assessment
Time Frame: Week 16
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Novartis

Investigators

  • Principal Investigator: Kilian Eyerich, MD, PhD, Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN547ADE01T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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