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Ilaris® Effects in Schnitzler Syndrome (ILESCH) (ILESCH)

Primary Purpose

Schnitzler Syndrome

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Canakinumab
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schnitzler Syndrome focused on measuring Schnitzler syndrome, autoinflammatory syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Adults (18 years or older)
  • Informed consent signed and dated
  • Able to read, understand and willing to sign the informed consent form and abide with study procedures
  • SchS diagnosis based on diagnostic criteria defined in Appendix
  • Patients with symptomatic Schnitzler syndrome [SchS] (as defined by the physician's global assessment with a minimum score of 8 and C-reactive protein [CRP] > upper limit of normal [ULN])
  • Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have subcutaneous injections administered by a qualified person
  • In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
  • Subjects are considered eligible, if they meet the following tuberculosis [TB] screening criteria: no history of latent or active TB prior to screening, no signs or symptoms suggestive of active TB, no recent close contacts with a person with active TB, and negative QuantiFERON-TB test at screening (if QuantiFERON-TB test is positive, the patient can only be included if active TB is ruled out with appropriate measurements according to standard of care)
  • No participation in other clinical trials 4 weeks before and after participation in this study

Exclusion Criteria:

  • Concurrent/ongoing treatment with anakinra (Kineret®) or recent treatment within 48 hours prior to day 0
  • Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives)
  • Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
  • Concurrent/ongoing treatment with high doses of systemic steroids (>20mg prednisolone equivalent)
  • Evidence of recurrent or latent systemic infection such as TB
  • Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
  • Treatment with a live (attenuated) virus vaccine during three months prior to day 0 and for 3 months after end of study
  • Evidence of tuberculosis as defined by local guidelines/ local medical practice (at screening)
  • An abnormal chest radiograph consistent with clinical signs of prior or present tuberculosis infection whether or not previously treated with anti-tuberculosis agents
  • A history of listeriosis, active persistent chronic or active infection(s) requiring treatment with parenteral antibiotics, parenteral antivirals, or parenteral antifungals within four weeks prior to day 0
  • Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
  • Evidence of current HIV, active hepatitis B, or hepatitis C infection by serological screening
  • History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
  • Presence of any of the following laboratory abnormalities at enrollment visit: creatinine >2.0 x ULN, WBC <3000/µl; platelet count <100000/µl ; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x ULN
  • Lactating females or pregnant females
  • Subjects for whom there is concern about compliance with the protocol procedures
  • Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
  • History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
  • Subjects who are detained officially or legally to an official institute

Sites / Locations

  • Allergie-Centrum-Charité, Charité University
  • Dept. of Dermatology, Klinikum Darmstadt
  • Dept. of Dermatology, University Heidelberg
  • Dept. of Dermatology, University Münster
  • Dept. of Dermatology, University Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Canakinumab

Arm Description

Outcomes

Primary Outcome Measures

The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment
Proportion of patients with complete response (based on physician's global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group

Secondary Outcome Measures

The safety and tolerability of canakinumab in subjects with Schnitzler syndrome
The change in biomarkers of inflammation during the treatment period with canakinumab
Biomarkers of inflammation include C-reactive protein, serum amyloid A and erythrocyte sedimentation rate
Changes in patients' quality of life during the treatment period with canakinumab
Patient's quality of life assessment includes the Dermatology Life Quality Index and SF 36

Full Information

First Posted
July 7, 2011
Last Updated
July 16, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01390350
Brief Title
Ilaris® Effects in Schnitzler Syndrome (ILESCH)
Acronym
ILESCH
Official Title
A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center double-blind placebo-controlled study to assess the efficacy and safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's global assessment (a combined clinical symptom score) and inflammation markers. Following a baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day 7. Patients will then be eligible to enter the 16-week open-label phase and receive canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled. Amendment: After successful completion of the 16-week open-label phase patients will be eligible to enter a one-year open-label extension of the study. During this part of the study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be performed upon relapse of symptoms comparable to the 16-week open-label phase. Amendment: After successful completion of the 1-year open-label study extension patients will be eligible to enter another 3-year open-label extension. Patients will be scheduled at 3-month-intervals and Canakinumab dosing will be performed on an individual basis with optimized dosing intervals to ensure a constant low disease activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schnitzler Syndrome
Keywords
Schnitzler syndrome, autoinflammatory syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Canakinumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Other Intervention Name(s)
Ilaris
Intervention Description
150mg subcutaneous injections on day 0
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
150mg subcutaneous injections on day 0
Primary Outcome Measure Information:
Title
The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment
Description
Proportion of patients with complete response (based on physician's global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group
Time Frame
16 months
Secondary Outcome Measure Information:
Title
The safety and tolerability of canakinumab in subjects with Schnitzler syndrome
Time Frame
16 months
Title
The change in biomarkers of inflammation during the treatment period with canakinumab
Description
Biomarkers of inflammation include C-reactive protein, serum amyloid A and erythrocyte sedimentation rate
Time Frame
16 months
Title
Changes in patients' quality of life during the treatment period with canakinumab
Description
Patient's quality of life assessment includes the Dermatology Life Quality Index and SF 36
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (18 years or older) Informed consent signed and dated Able to read, understand and willing to sign the informed consent form and abide with study procedures SchS diagnosis based on diagnostic criteria defined in Appendix Patients with symptomatic Schnitzler syndrome [SchS] (as defined by the physician's global assessment with a minimum score of 8 and C-reactive protein [CRP] > upper limit of normal [ULN]) Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have subcutaneous injections administered by a qualified person In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) Subjects are considered eligible, if they meet the following tuberculosis [TB] screening criteria: no history of latent or active TB prior to screening, no signs or symptoms suggestive of active TB, no recent close contacts with a person with active TB, and negative QuantiFERON-TB test at screening (if QuantiFERON-TB test is positive, the patient can only be included if active TB is ruled out with appropriate measurements according to standard of care) No participation in other clinical trials 4 weeks before and after participation in this study Exclusion Criteria: Concurrent/ongoing treatment with anakinra (Kineret®) or recent treatment within 48 hours prior to day 0 Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives) Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer Concurrent/ongoing treatment with high doses of systemic steroids (>20mg prednisolone equivalent) Evidence of recurrent or latent systemic infection such as TB Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial Treatment with a live (attenuated) virus vaccine during three months prior to day 0 and for 3 months after end of study Evidence of tuberculosis as defined by local guidelines/ local medical practice (at screening) An abnormal chest radiograph consistent with clinical signs of prior or present tuberculosis infection whether or not previously treated with anti-tuberculosis agents A history of listeriosis, active persistent chronic or active infection(s) requiring treatment with parenteral antibiotics, parenteral antivirals, or parenteral antifungals within four weeks prior to day 0 Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study Evidence of current HIV, active hepatitis B, or hepatitis C infection by serological screening History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer Presence of any of the following laboratory abnormalities at enrollment visit: creatinine >2.0 x ULN, WBC <3000/µl; platelet count <100000/µl ; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x ULN Lactating females or pregnant females Subjects for whom there is concern about compliance with the protocol procedures Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures Subjects who are detained officially or legally to an official institute
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karoline Krause, MD
Organizational Affiliation
Charité University, Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergie-Centrum-Charité, Charité University
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Dept. of Dermatology, Klinikum Darmstadt
City
Darmstadt
Country
Germany
Facility Name
Dept. of Dermatology, University Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Dept. of Dermatology, University Münster
City
Münster
Country
Germany
Facility Name
Dept. of Dermatology, University Tübingen
City
Tübingen
Country
Germany

12. IPD Sharing Statement

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Ilaris® Effects in Schnitzler Syndrome (ILESCH)

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