Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses (ILUVIT)
This study has been completed.
First Posted: July 28, 2010
Last Update Posted: May 31, 2012
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.
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Information provided by (Responsible Party):
Karoline Krause, Charite University, Berlin, Germany
This is a single-center open label study to assess the efficacy and safety of single doses of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10 subjects with urticarial vasculitis will be enrolled.
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||An Open-label Pilot Study to Assess the Efficacy and Safety of a Single Dose Regime of Canakinumab (ACZ885) in Patients With Active, Refractory Urticarial Vasculitis
Primary Outcome Measures:
- Effect of single doses of canakinumab on the clinical signs and symptoms of urticarial vasculitis measured by the urticarial vasculitis activity score (UVAS) [ Time Frame: 18 weeks ]
Change in the mean UV activity score (UVAS) from the baseline phase (day -14 to day 0) to the last 2 weeks of the first 4 weeks treatment phase (day 15 to 28) of the study (The UVAS combines the key symptoms of UV). Daily UVAS values will be documented using DHAFs (Daily Health Assessment Forms). Values for the Sum UVAS can range from 0 to 50 per day (5 symptoms, 0-10 each). Mean Daily UVAS will be calculated by dividing the sum of the daily activity scores by 5.
Secondary Outcome Measures:
- Safety and tolerability following administration of canakinumab to patients with active urticarial vasculitis [ Time Frame: 18 weeks ]
Safety and tolerability: This includes physical examination, electrocardiogram, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
Single dose of canakinumab 300mg s.c. injection
Other Name: Ilaris
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:
|Accepts Healthy Volunteers:
- Adults (18 years or older)
- UV diagnosis based on diagnostic criteria defined in Appendix 3
- Active UV, refractory to treatment with antihistamines, NSAIDS or colchicine, hydroxychloroquine or dapsone
- Patients who have a mean symptom score (UVAS) of at least 5 during baseline
- If necessary, concurrent/ongoing treatment with a stable dose of systemic corticosteroids not greater than 10mg/d for 14 days prior to screening
- If necessary, concurrent/ongoing treatment with a stable dose of antihistamines and NSAIDs for 7 days prior to screening
- Informed consent signed and dated
- Able to read, understand and willing to sign the informed consent form and abide with study procedures
- Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
- In females of childbearing potential: Negative pregnancy test; males and 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)
- In men: Willingness to utilize highly effective contraception and to not have their partner become pregnant during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for two or more cycles prior to screening); bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01170936
|Berlin, Germany, 10117 |
Charite University, Berlin, Germany
||Marcus Maurer, MD
||Charite University, Berlin, Germany
||Karoline Krause, Karoline Krause, MD, Charite University, Berlin, Germany
History of Changes
|Other Study ID Numbers:
2010-020063-21 ( EudraCT Number )
||July 26, 2010
||July 28, 2010
|Last Update Posted:
||May 31, 2012
Keywords provided by Karoline Krause, Charite University, Berlin, Germany:
Additional relevant MeSH terms:
Skin Diseases, Vascular
Immune System Diseases
Physiological Effects of Drugs