Efficacy Study of Canakinumab to Treat Urticaria (URTICANA)
Primary Purpose
Chronic Idiopathic Urticaria
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Canakinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic idiopathic urticaria for more than 6 weeks as confirmed by clinical and, if necessary, histological examination
CIU of moderate to severe severity defined by all of the following
- Physician severity score of 2 or 3 (on a scale from 0 - 3)
- Run-in period of the diary-based UAS7 score of > 21 (on a scale from 0 - 42)
- Symptomatic despite use of non-sedating antihistamine with or without concomitant leukotriene antagonist/corticosteroids
- Use of maintenance non-sedating antihistamine at a stable dose for at least 1 week prior to entering run-in period
- Maintenance corticosteroids at a dose of <20 mg/day or <0.4 mg/kg stable for at least the week prior to study entry for treatment of the patient's CIU will be allowed.
- Age: > 18 years.
- Signed informed consent
- Negative or unreactive QuantiFERON test (QFT-TB G In-Tube) or history of adequate treatment of active or latent tuberculosis.
Exclusion criteria:
- Age < 18 or > 70 years
- History of cancer except for treated basal cell carcinoma of the skin
- With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
Patients currently treated with systemic immunosuppressive agents or following treatments in the specified period before the baseline visit:
- corticosteroids =20 mg/day or >0.4 mg/kg for 1 week prior to study entry;
- leukotriene antagonists for 1 week prior to study entry
- colchicine, dapsone or mycophenolate mofetil for 3 weeks;
- etanercept, leflunomide (documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required), thalidomide or ciclosporin for 4 weeks;
- adalimumab or intravenous immunoglobulin for 8 weeks;
- infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil for 12 weeks
- Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study, lack of safe contraception.
- Safe contraception is defined as follows:
- Double-barrier contraception such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices together with condom use.
- Both men and women must use safe contraception (double-barrier as defined above) during the duration of the study and until 6 months after the study.
- Please note that female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Sites / Locations
- University Hospital Zurich, Division of DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Canakinumab
Placebo
Arm Description
Monoclonal antibody inhibiting interleukin 1 beta
Constituent, inactive
Outcomes
Primary Outcome Measures
Complete clinical remission
Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01635127
Brief Title
Efficacy Study of Canakinumab to Treat Urticaria
Acronym
URTICANA
Official Title
A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation whether canakinumab leads to improvement of urticaria
Detailed Description
Single center prospective placebo-controlled cross-over phase II study.
To assess if canakinumab can induce clinical improvement and/or complete clinical remission of chronic idiopathic urticaria at week 4 as compared to placebo
To compare canakinumab and placebo treated patients in the percentage who achieve complete clinical remission at week 1, 2, 4, and 8.
To compare the percentage with clinical improvement as measured by UAS7 score at week 1, 2, 4, and 8 in canakinumab and placebo treated patients
To compare the percentage of canakinumab and placebo treated patients with 75% and 100% improvement of their baseline (Run-in-period) UAS7 score at week 1,2,4,and 8
To compare the daily wheal score for Days 1 to 7 in canakinumab and placebo treated patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab
Arm Type
Experimental
Arm Description
Monoclonal antibody inhibiting interleukin 1 beta
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Constituent, inactive
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Other Intervention Name(s)
Ilaris
Intervention Description
150mg s.c.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Constituent of canakinumab
Primary Outcome Measure Information:
Title
Complete clinical remission
Description
Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Diagnosis of chronic idiopathic urticaria for more than 6 weeks as confirmed by clinical and, if necessary, histological examination
CIU of moderate to severe severity defined by all of the following
Physician severity score of 2 or 3 (on a scale from 0 - 3)
Run-in period of the diary-based UAS7 score of > 21 (on a scale from 0 - 42)
Symptomatic despite use of non-sedating antihistamine with or without concomitant leukotriene antagonist/corticosteroids
Use of maintenance non-sedating antihistamine at a stable dose for at least 1 week prior to entering run-in period
Maintenance corticosteroids at a dose of <20 mg/day or <0.4 mg/kg stable for at least the week prior to study entry for treatment of the patient's CIU will be allowed.
Age: > 18 years.
Signed informed consent
Negative or unreactive QuantiFERON test (QFT-TB G In-Tube) or history of adequate treatment of active or latent tuberculosis.
Exclusion criteria:
Age < 18 or > 70 years
History of cancer except for treated basal cell carcinoma of the skin
With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
Patients currently treated with systemic immunosuppressive agents or following treatments in the specified period before the baseline visit:
corticosteroids =20 mg/day or >0.4 mg/kg for 1 week prior to study entry;
leukotriene antagonists for 1 week prior to study entry
colchicine, dapsone or mycophenolate mofetil for 3 weeks;
etanercept, leflunomide (documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required), thalidomide or ciclosporin for 4 weeks;
adalimumab or intravenous immunoglobulin for 8 weeks;
infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil for 12 weeks
Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study, lack of safe contraception.
Safe contraception is defined as follows:
Double-barrier contraception such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices together with condom use.
Both men and women must use safe contraception (double-barrier as defined above) during the duration of the study and until 6 months after the study.
Please note that female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.
Participation in another study with investigational drug within the 30 days preceding and during the present study.
Previous enrolment into the current study.
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonios Kolios, MD
Phone
+41 (0)44 255 11 11
Email
antonios.kolios@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Navarini, MD PhD
Email
alexander.navarini@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schmid-Grendelmeier, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Dermatology
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
32827729
Citation
Maul JT, Distler M, Kolios A, Maul LV, Guillet C, Graf N, Imhof L, Lang C, Navarini AA, Schmid-Grendelmeier P. Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-Blind Placebo-Controlled Single-Center Study. J Allergy Clin Immunol Pract. 2021 Jan;9(1):463-468.e3. doi: 10.1016/j.jaip.2020.07.058. Epub 2020 Aug 20.
Results Reference
derived
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Efficacy Study of Canakinumab to Treat Urticaria
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