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

NCT02733094 | Completed Phase 1

• 1 other identifier: CAIN547ADE01T
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Week 2,3,8,16,28,40

• Assessment of patient's quality of life

  Week 2, 4, 8, 16, 28, 40

• Measurement of serum C reactive protein (mg/dl)

  Week 2, 4, 8, 16, 28, 40

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

  Week 2, 4, 8, 16, 28, 40

• Measurement of blood sedimentation rate (mm/h)

  Week 2, 4, 8, 16, 28, 40

Study Arms (1)

Open-label

EXPERIMENTAL

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

Drug: Secukinumab

Interventions

Secukinumab DRUG

Open-label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age
• Body weight ≥ 40 kg and ≤ 160 kg
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Novartis: collaborator

Study Sites (1)

Technical University of Munich

Munich, 80802, Germany

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Kilian Eyerich, MD, PhD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 11, 2016
• Study Start: April 1, 2016
• Primary Completion: September 10, 2019
• Study Completion: September 19, 2019
• Last Updated: April 12, 2023

Record last verified: 2020-02

Locations

DE (1)