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Completed

NCT Number: NCT02733094

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

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.

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Key information

Conditions

Pyoderma Gangrenosum Pyoderma Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Technical University of Munich

Munich, 80802, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

secukinumab

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)

    Time frame: Week 2,3,8,16,28,40

  2. 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.

  3. Measurement of serum C reactive protein (mg/dl)

    Time frame: Week 2, 4, 8, 16, 28, 40

  4. Measurement of leukocyte counts (x10.e3/µl)

    Time frame: Week 2, 4, 8, 16, 28, 40

  5. Measurement of blood sedimentation rate (mm/h)

    Time frame: Week 2, 4, 8, 16, 28, 40

  6. 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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2016
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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