Chronic Idiopathic UrticariaPhase 2URTICANANCT01635127
Efficacy Study of Canakinumab to Treat Urticaria
A Phase 2 study testing Canakinumab in people with Chronic Idiopathic Urticaria, run by University of Zurich at 1 site in Switzerland.
Trial summary
Evaluation whether canakinumab leads to improvement of urticaria Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- Canakinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to May 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Alexander Navarini, MD PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Division of Dermatology
Zurich
About this study
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
Evaluation whether canakinumab leads to improvement of urticaria
Read the 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
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- Canakinumab, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called Ilaris
150mg s.c.
PlaceboDrug
Constituent of canakinumab
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab | Experimental | Monoclonal antibody inhibiting interleukin 1 beta Receives: Drug: Canakinumab |
| Placebo | Placebo comparator | Constituent, inactive Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical remission
Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Schmid-Grendelmeier, Prof MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635127
- Sponsor's protocol ID
- USZ-DER-AAN-017
- Acronym
- URTICANA
- Status last verified
- Sep 2016
- First submitted
- 3 Jul 2012
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32827729
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01635127
- Acronym / sponsor ID
- URTICANA / USZ-DER-AAN-017
- Conditions
- Chronic Idiopathic Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 6 Jul 2012 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canakinumab | Experimental | Drug: CanakinumabMonoclonal antibody inhibiting interleukin 1 beta |
| Placebo | Placebo comparator | Drug: PlaceboConstituent, inactive |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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.
Key exclusion criteria (21 listed)
- 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:
- Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
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 s.c. | Drug | Canakinumab |
| PlaceboConstituent of canakinumab | Drug | Placebo |
Primary outcome
Complete clinical remission
Time frame: 4 weeks
Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 32827729Maul 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.
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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.
Alexander Navarini, MD PhD contact
Peter Schmid-Grendelmeier, Prof MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site 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 Chronic Idiopathic Urticaria, run by University of Zurich at 1 site in Switzerland.
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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonios Kolios, MD (+41 (0)44 255 11 11, antonios.kolios@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical remission (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635127, which also lists 1 linked publication.
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 27 Sep 2016.