Trial record 19 of 125 for:    autoinflammatory

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01390350
Recruitment Status : Active, not recruiting
First Posted : July 11, 2011
Last Update Posted : February 23, 2018
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Karoline Krause, Charite University, Berlin, Germany

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.

  1. 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.
  2. 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.

Condition or disease Intervention/treatment Phase
Schnitzler Syndrome Drug: Canakinumab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : December 21, 2017
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
150mg subcutaneous injections on day 0
Experimental: Canakinumab Drug: Canakinumab
150mg subcutaneous injections on day 0
Other Name: Ilaris

Primary Outcome Measures :
  1. The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment [ Time Frame: 16 months ]
    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 :
  1. The safety and tolerability of canakinumab in subjects with Schnitzler syndrome [ Time Frame: 16 months ]
  2. The change in biomarkers of inflammation during the treatment period with canakinumab [ Time Frame: 16 months ]
    Biomarkers of inflammation include C-reactive protein, serum amyloid A and erythrocyte sedimentation rate

  3. Changes in patients' quality of life during the treatment period with canakinumab [ Time Frame: 16 months ]
    Patient's quality of life assessment includes the Dermatology Life Quality Index and SF 36

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01390350

Allergie-Centrum-Charité, Charité University
Berlin, Germany, 10117
Dept. of Dermatology, Klinikum Darmstadt
Darmstadt, Germany
Dept. of Dermatology, University Heidelberg
Heidelberg, Germany
Dept. of Dermatology, University Münster
Münster, Germany
Dept. of Dermatology, University Tübingen
Tübingen, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis Pharmaceuticals
Principal Investigator: Karoline Krause, MD Charité University, Berlin

Responsible Party: Karoline Krause, Karoline Krause, MD, Charite University, Berlin, Germany Identifier: NCT01390350     History of Changes
Other Study ID Numbers: CACZ885DDE03T
2010-024156-28 ( EudraCT Number )
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Karoline Krause, Charite University, Berlin, Germany:
Schnitzler syndrome
autoinflammatory syndrome

Additional relevant MeSH terms:
Schnitzler Syndrome
Pathologic Processes
Monoclonal Gammopathy of Undetermined Significance
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs