Schnitzler SyndromePhase 2ILESCHNCT01390350
Ilaris® Effects in Schnitzler Syndrome (ILESCH)
A Phase 2 study testing Canakinumab in people with Schnitzler Syndrome, run by Charite University, Berlin, Germany at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schnitzler Syndrome
- What is being tested?
- Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2011to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Allergie-Centrum-Charité, Charité University
Berlin, 10117
Dept. of Dermatology, Klinikum Darmstadt
Darmstadt
Dept. of Dermatology, University Heidelberg
Heidelberg
Dept. of Dermatology, University Münster
Münster
Dept. of Dermatology, University Tübingen
Tübingen
About this study
Official title: A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome
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.
- Conditions
- Schnitzler Syndrome
- Being tested
- Canakinumab, Placebo
- Keywords
- Schnitzler syndrome, autoinflammatory syndrome
- Medical subject headings
- Schnitzler Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called Ilaris
150mg subcutaneous injections on day 0
PlaceboDrug
150mg subcutaneous injections on day 0
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Canakinumab | Experimental | Not described Receives: Drug: Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 months
Secondary outcomes (3)
The safety and tolerability of canakinumab in subjects with Schnitzler syndrome
Measured: 16 months
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
Measured: 16 months
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
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completion21 Dec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schnitzler SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Karoline Krause, Charite University, Berlin, Germany
- Investigators
- Karoline Krause, MD, Principal investigator, Charité University, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390350
- Sponsor's protocol ID
- CACZ885DDE03T
- Other IDs
- 2010-024156-28
- Acronym
- ILESCH
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2011
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome
- ClinicalTrials.gov ID
- NCT01390350
- Acronym / sponsor ID
- ILESCH / CACZ885DDE03T
- Conditions
- Schnitzler Syndrome
- Keywords
- Schnitzler syndrome, autoinflammatory syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jul 2011
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Canakinumab | Experimental | Drug: Canakinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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])
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: Ilaris150mg subcutaneous injections on day 0 | Drug | Canakinumab |
| Placebo150mg subcutaneous injections on day 0 | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
The safety and tolerability of canakinumab in subjects with Schnitzler syndrome
Time frame: 16 months
The change in biomarkers of inflammation during the treatment period with canakinumab
Time frame: 16 months
Changes in patients' quality of life during the treatment period with canakinumab
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Related trials for Schnitzler Syndrome
RecruitingObservational study
A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome
Schnitzler Syndrome
RecruitingObservational study
AutoInflammatory Disease Alliance Registry (AIDA)
Hereditary Autoinflammatory Diseases, Schnitzler Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karoline Krause, MD principal investigator
Charité University, Berlin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab in people with Schnitzler Syndrome, run by Charite University, Berlin, Germany at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.