Chronic Spontaneous UrticariaPhase 3LEVURE PLUSNCT02372604
Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria
A Phase 3 study testing Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration. and Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration. in people with Chronic Spontaneous Urticaria, run by Hospices Civils de Lyon.
Trial summary
Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration. and Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 3
- 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
- Subject must be ≥18 years of age at screening.
- Chronic spontaneous urticaria already treated with anti-H1 for at least two months without sufficient efficacy.
- Urticaria Activity Score (UAS7) >12 at the randomization visit (visit 2).
- For female :
- Of childbearing potential: female must use an acceptable method of contraception during the period of 1 month before the inclusion to 1 month after the last study visit;
- Of non-childbearing potential: e.g. postmenopausal (absence of menstrual bleeding for 1 years), or having had a hysterectomy or bilateral ovariectomy or tubal ligation.
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- Patient agrees not to take other treatments than those provided in the study.
- Willingness and ability to comply with the protocol requirements.
- Written informed consent given prior to any study-related procedure.
- Subject affiliated to the National Social Security System.
Who cannot join
- Pregnancy, breastfeeding or planned pregnancy during the study.
- Inducible urticaria (except immediate dermographism associated with CSU)
- Differential diagnosis of CSU (urticarial vasculitis).
- Known hypersensitivity to antihistamine.
- Known hypersensitivity to one of the product components, to hydroxyzine or to piperazine derivative.
- Sleepiness disorders or with Epworth sleepiness scale >15.
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- Treatment with systemic corticosteroids within the month before the screening visit.
- Treatment with montelukast within the week before the screening visit.
- Treatment with H2-antihistamine within the week before the screening visit.
- Treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil …) within the month before the screening visit.
- Known congenital galactosemia, glucose and galactose malabsorption, lactase deficiency, or lactose and fructose intolerance.
- Swallowing disorders.
- Liver dysfunction with transaminase greater than twice the normal value.
- Renal failure with creatinine clearance <50mL/min (calculated by MDRD formula).
- Regular or excessive alcohol consumption.
- Unstabilized chronic disease under treatment.
- Subject protected by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated).
- Subject with any additional condition that, in the opinion of the investigator, may interfere with the study assessment or put the subject at risk.
- Linguistic or mentally incapacity to sign the consent form.
- Subject in an exclusion period from a previous study or who is participating in another clinical trial
About this study
Official title: Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage
Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine.
The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology.
This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration., Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.
- Keywords
- Chronic spontaneous urticaria, Levocetirizine, H1-antihistamine, Fourfold dosage, Efficacy, Tolerance, UAS7 (Urticaria activity score), resistant
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.Drug
Week 1 to week 5, every day : - the morning : 5 mg of levocetirizine (capsule)
- the evening : placebo capsule
Week 6 to week 10, every day : - the morning : 10 mg of levocetirizine (capsule)
- the evening : 10 mg of levocetirizine (capsule))
Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.Drug
Week 1 to week 5, every day : - the morning : 10 mg of levocetirizine (tablet)
- the evening : 10 mg of levocetirizine(tablet)
Week 6 to week 10, every day : - the morning : 5 mg of levocetirizine (tablet)
- the evening : placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Group1 : Regulatory dosage | Active comparator | In a first time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 2 and 3).
In a second time,and after primary endpoint assessment, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 3 and 4). Receives: Drug: Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration. |
| Group 2 : fourfold dosage | Experimental | In a first time, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 2 and 3).
In a second time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 3 and 4). Receives: Drug: Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS7≤6 (Proportion of patients with a UAS7≤6).
The UAS7 (Urticaria activity score) is calculated as the sum of UAS over 1 week.
Measured: After 5 weeks of treatment (plus or minus 2 days; week 5- visit 3).
Secondary outcomes (5)
Score of pruritus -> Assessment of the weekly score of pruritus
Measured: 5 weeks -> After 5 weeks of treatment (visit 3).
Complete remission of urticaria at week 5
Proportion of patients in complete remission of urticaria after 5 weeks of treatment (UAS7 = 0).
Measured: 5 weeks -> After 5 weeks of treatment (visit 3).
Complete remission of urticaria
Proportion of patients in complete remission of urticaria after 10 weeks of treatment (UAS7 =0).
Measured: 10 weeks -> After 10 weeks of treatment (visit 4).
Quality of life -> Evolution of the quality of life (between week 0, week 5 and week 10).
The quality of the life is evaluated by two questionnaires, the DLQI (DERMATOLOGY LIFE QUALITY INDEX) and the CU-Q2oL (Chronic Urticaria Quality of Life Questionnaire). The DLQI and CU-Q2oL scores are calculated by summing the score of each question.
Measured: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10).
Tolerance of the treatment -> assessment of the tolerance of the H1-antihistamine in up 4 times conventional doses compared to the regulatory dosage of H1-antihistamine.
The tolerance is evaluated by one questionnaire, the Epworth sleepiness scale (ESS). The ESS is an effective instrument used to measure average daytime vigilance and sleepiness. It is calculated by summing the score of each question.
Measured: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric BERARD, Professor, Principal investigator, Service d'Allergologie et Immunologie Clinique - Centre Hospitalier Universitaire Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372604
- Sponsor's protocol ID
- 2014.849
- Acronym
- LEVURE PLUS
- Status last verified
- Sep 2018
- First submitted
- 20 Feb 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage
- ClinicalTrials.gov ID
- NCT02372604
- Acronym / sponsor ID
- LEVURE PLUS / 2014.849
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic spontaneous urticaria, Levocetirizine, H1-antihistamine, Fourfold dosage, Efficacy, Tolerance, UAS7 (Urticaria activity score), resistant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Feb 2015 (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.
Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine.
The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology.
This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 : Regulatory dosage | Active comparator | Drug: Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.In a first time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 2 and 3). In a second time,and after primary endpoint assessment, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 3 and 4). |
| Group 2 : fourfold dosage | Experimental | Drug: Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.In a first time, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 2 and 3). In a second time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 3 and 4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be ≥18 years of age at screening.
- Chronic spontaneous urticaria already treated with anti-H1 for at least two months without sufficient efficacy.
- Urticaria Activity Score (UAS7) >12 at the randomization visit (visit 2).
- For female :
- Patient agrees not to take other treatments than those provided in the study.
Key exclusion criteria (20 listed)
- Pregnancy, breastfeeding or planned pregnancy during the study.
- Inducible urticaria (except immediate dermographism associated with CSU)
- Differential diagnosis of CSU (urticarial vasculitis).
- Known hypersensitivity to antihistamine.
- Known hypersensitivity to one of the product components, to hydroxyzine or to piperazine derivative.
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 |
|---|---|---|
| Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.Week 1 to week 5, every day : - the morning : 5 mg of levocetirizine (capsule) * the evening : placebo capsule Week 6 to week 10, every day : - the morning : 10 mg of levocetirizine (capsule) * the evening : 10 mg of levocetirizine (capsule)) | Drug | Group1 : Regulatory dosage |
| Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.Week 1 to week 5, every day : - the morning : 10 mg of levocetirizine (tablet) * the evening : 10 mg of levocetirizine(tablet) Week 6 to week 10, every day : - the morning : 5 mg of levocetirizine (tablet) * the evening : placebo tablet | Drug | Group 2 : fourfold dosage |
Primary outcome
UAS7≤6 (Proportion of patients with a UAS7≤6).
Time frame: After 5 weeks of treatment (plus or minus 2 days; week 5- visit 3).
The UAS7 (Urticaria activity score) is calculated as the sum of UAS over 1 week.
5 secondary outcomes
Score of pruritus -> Assessment of the weekly score of pruritus
Time frame: 5 weeks -> After 5 weeks of treatment (visit 3).
Complete remission of urticaria at week 5
Time frame: 5 weeks -> After 5 weeks of treatment (visit 3).
Complete remission of urticaria
Time frame: 10 weeks -> After 10 weeks of treatment (visit 4).
Quality of life -> Evolution of the quality of life (between week 0, week 5 and week 10).
Time frame: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10).
Tolerance of the treatment -> assessment of the tolerance of the H1-antihistamine in up 4 times conventional doses compared to the regulatory dosage of H1-antihistamine.
Time frame: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10).
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 18 Sep 2018.
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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.
Frédéric BERARD, Professor principal investigator
Service d'Allergologie et Immunologie Clinique - Centre Hospitalier Universitaire Lyon Sud
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration. and Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration. in people with Chronic Spontaneous Urticaria, run by Hospices Civils de Lyon.
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 20 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
UAS7≤6 (Proportion of patients with a UAS7≤6). (time frame: After 5 weeks of treatment (plus or minus 2 days; week 5- visit 3).). 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 18 Sep 2018.