Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
NCT ID: NCT02733094
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2016-04-30
2019-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label
300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.
Secukinumab
Interventions
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Secukinumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Kilian Eyerich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Technical University of Munich
Locations
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Technical University of Munich
Munich, , Germany
Countries
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Other Identifiers
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CAIN547ADE01T
Identifier Type: -
Identifier Source: org_study_id
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