Ilaris® Effects in Schnitzler Syndrome (ILESCH)

Brief Title

Ilaris® Effects in Schnitzler Syndrome (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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment

Secondary Outcome

 The safety and tolerability of canakinumab in subjects with Schnitzler syndrome

Condition

Schnitzler Syndrome

Intervention

Canakinumab

Study Arms / Comparison Groups

 Placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

July 2011

Completion Date

May 2018

Primary Completion Date

December 21, 2017

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karoline Krause, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01390350

Organization ID

CACZ885DDE03T

Secondary IDs

2010-024156-28

Responsible Party

Principal Investigator

Study Sponsor

Charite University, Berlin, Germany

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Karoline Krause, MD, Principal Investigator, Charité University, Berlin


Verification Date

July 2018