Chronic Spontaneous UrticariaPhase 2NCT04109313
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
A Phase 2 study testing LOU064 in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 69 sites in 15 countries.
Trial summary
The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- LOU064
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 69 sitesin 15 countries
- Study dates
- 24 Oct 2019to 9 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must provide written informed consent prior to any assessments.
- Participants must be willing and able to complete a daily symptom eDiary throughout the study and adhere to the study visit schedules.
- Participants transitioning from the CLOU064A2201 trial must have completed either the Week 12 visit (end of treatment period) or the Week 16 visit (end of follow-up period). They will be assigned to either the treatment period or the observational period based on their UAS7 score (average score from the 7 days prior to the respective visit) as follows:
- Participants transitioning at Week 12 of CLOU064A2201 with a UAS7 score of ≥16 will be allocated to the treatment period.
- Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of ≥16 will be allocated to the treatment period.
- Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of <16 will be allocated to the observational period.
Who cannot join
- Participants with a clearly defined predominant or sole trigger for their chronic urticaria, such as chronic inducible urticaria (including symptomatic dermographism, cold-induced, heat-induced, solar-induced, pressure-induced, delayed pressure-induced, aquagenic-induced, cholinergic-induced, or contact-induced urticaria).
- Participants with other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
- Participants with any other skin disease associated with chronic itching that, in the opinion of the investigator, could affect the study evaluations and results, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis.
- Participants with a history or current diagnosis of ECG abnormalities that indicate a significant safety risk for their participation in the study, including:
- Concomitant clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia) and clinically significant second or third-degree AV block without a pacemaker.
- History of familiar long QT syndrome or a known family history of Torsades de Pointes.
Show all 11Show fewer
- Resting heart rate (as determined by physical exam or 12-lead ECG) below 50 bpm.
- Resting QTcF interval ≥450 msec (in males) or ≥460 msec (in females) at day 1 of the treatment period or inability to determine the QTcF interval.
- Use of agents known to prolong the QT interval, unless they can be permanently discontinued for the duration of the study.
- Participants with a significant risk of bleeding or coagulation disorders.
- Participants with a known or suspected history of an ongoing, chronic, or recurrent infectious disease, including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis, or aspergillosis), HIV, or Hepatitis B/C.
Trial locations and contacts
69 sites in 15 countries.
69 sites in 15 countries
United States10 sites
Novartis Investigative Site
Grove City, Ohio, 43123
Novartis Investigative Site
Litchfield Park, Arizona, 85340
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Pembroke Pines, Florida, 33028
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Walnut Creek, California, 94598
Novartis Investigative Site
Ypsilanti, Michigan, 48197
Japan9 sites
Novartis Investigative Site
Funabashi, Chiba, 273-0031
Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551
Novartis Investigative Site
Ichinomiya, Aichi-ken, 491-0041
Novartis Investigative Site
Itabashi-ku, Tokyo, 173-8610
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013
Novartis Investigative Site
Takaoka, Toyama, 933-0871
Novartis Investigative Site
Yokohama, Kanagawa, 220-6208
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825
Novartis Investigative Site
Yokohama, Kanagawa, 240-0013
Canada6 sites
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3
Novartis Investigative Site
London, Ontario, N6H 5L5
Novartis Investigative Site
Niagara Falls, Ontario, L2H 1H5
Novartis Investigative Site
Ottawa, Ontario, K1G 6C6
Novartis Investigative Site
Québec, Quebec, G1V 4W2
Novartis Investigative Site
Verdun, Quebec, H4G 3E7
Spain6 sites
Novartis Investigative Site
Alicante, Valencia, 03010
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28046
Hungary5 sites
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Orosháza, Bekes County, 5900
Novartis Investigative Site
Pécs, 7632
Novartis Investigative Site
Szolnok, 5000
Poland5 sites
Novartis Investigative Site
Gdansk, 80 803
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Warsaw, 02 777
Argentina4 sites
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF
Novartis Investigative Site
CABA, 1035
Novartis Investigative Site
La Plata, Buenos Aires, B1902COS
Novartis Investigative Site
Mendoza, Mendoza Province, M5500AWD
Russia4 sites
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 195112
Novartis Investigative Site
Stavropol, 355000
United Kingdom4 sites
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Oxford, OX3 7LJ
Novartis Investigative Site
Plymouth, PL6 8DH
Czechia3 sites
Novartis Investigative Site
Prague, Czech Republic, 180 00
Novartis Investigative Site
Prague, Prague 1, 11000
Novartis Investigative Site
Tábor, 390 01
France3 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 06202
Slovakia3 sites
Novartis Investigative Site
Košice, Slovak Republic, 040 15
Novartis Investigative Site
Nové Zámky, 940 34
Novartis Investigative Site
Svidník, 08901
Turkey (Türkiye)3 sites
Novartis Investigative Site
Denizli, 20070
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Talas / Kayseri, 38039
Belgium2 sites
Novartis Investigative Site
Edegem, Antwerpen, 2650
Novartis Investigative Site
Liège, 4000
Denmark2 sites
Novartis Investigative Site
Arhus C, DK 8000
Novartis Investigative Site
Copenhagen NV, 2400
About this study
Official title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201
The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)
Read the detailed description
This was an open-label, single-arm, multicenter, long-term safety and tolerability extension study for CSU patients rolling over from study CLOU064A2201 (NCT03926611).
Subjects rolling over from CLOU064A2201 with a weekly Urticaria Activity Score (UAS7)<16 after the follow-up period at Week 16 were further followed up without receiving LOU064 for up to 12 weeks (observational period). If there was a relapse (UAS7≥16 at least once), the 12-week observational period was terminated, and subjects entered the treatment period. Subjects who never relapsed within 12 weeks completed the study after the observational period without treatment.
Subjects who rolled over from CLOU064A2201 with a UAS7≥16 at Week 12 or Week 16, as well as those subjects who relapsed during the 12-week observational period, were treated with 100 mg LOU064 twice a day (b.i.d.) open-label for 52 weeks. No background medication with a second-generation H1-antihistamine was permitted up to Week 4 of the treatment period. Subjects who completed the treatment period or who discontinued treatment early were followed-up for a minimum duration of 4 weeks. Subjects who had a UAS7≤6 at Week 52 of the treatment period had their follow-up period extended until relapse (UAS7≥16) for up to a total of 16 weeks.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- LOU064
- Keywords
- Chronic spontaneous urticaria, BTK Inhibitor, Long term safety, Urticaria activity score
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOU064Drug
Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Participants with UAS7<16 at Week 16 of CLOU064A2201 were followed up to 12 weeks without receiving treatment (observational period). If participants relapsed (UAS7≥16 at least once), they were transitioned to the treatment period. Otherwise, they were discontinued from the study.
Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered 100 mg of LOU064 b.i.d. open-label for up to 52 weeks. Receives: Drug: LOU064 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (AEs)
An AE refers to any undesirable medical occurrence, such as an unintended sign (including abnormal laboratory findings), symptom, or disease, experienced by a participant. Serious AEs (SAEs) is defined as any AE that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or any other medically significant condition.
Treatment-emergent AEs were defined as AEs that either begin on the same day or after the first dose of study medication during the treatment period in the extension study or worsen on the same day or after the first dose of study medication in the extension study and within the minimum of either 28 days post last dose or the end of the study visit. The number of participants with treatment-emergent AEs was summarized.
Measured: From first dose of treatment up to 28 days after last dose, assessed up to 56 weeks
Secondary outcomes (5)
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment Period
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The change from baseline in UAS7 at Week 4 of the treatment period was calculated. A negative change score from baseline indicates improvement. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.
Measured: Baseline, Week 4 of treatment period
Percentage of Participants With Well-controlled Disease (UAS7≤6) at Week 4 of the Treatment Period
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness.
The percentage of subjects with UAS7≤ 6 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.
Measured: Week 4 of the treatment period
Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment Period
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness.
The percentage of subjects with UAS7= 0 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.
Measured: Week 4 of the treatment period
Percentage of Participants With Well-controlled Disease (UAS7≤ 6) Overtime
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The percentage of subjects with UAS7≤ 6 during the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.
Measured: From baseline until Week 52 of the treatment period
Change From Baseline in UAS7 Overtime
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The change from baseline in UAS7 during the treatment period was calculated. A negative change score from baseline indicates improvement. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.
Measured: From baseline until Week 52 of the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start24 Oct 2019
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceutical, Study director, Novartis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109313
- Sponsor's protocol ID
- CLOU064A2201E1
- Other IDs
- 2019-001074-29, 2019
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2019
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Jain V, Gimenez-Arnau A, Hayama K, Reich A, Carr W, Tillinghast J, Dahale S, Lheritier K, Walsh P, Zharkov A, Hugot S, Haemmerle S. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol. 2024 Feb;153(2):479-486.e4. doi: 10.1016/j.jaci.2023.10.007. Epub 2023 Oct 20.
PubMed 37866460
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201
- ClinicalTrials.gov ID
- NCT04109313
- Acronym / sponsor ID
- CLOU064A2201E1
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic spontaneous urticaria, BTK Inhibitor, Long term safety, Urticaria activity score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 29 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)
Detailed description
This was an open-label, single-arm, multicenter, long-term safety and tolerability extension study for CSU patients rolling over from study CLOU064A2201 (NCT03926611).
Subjects rolling over from CLOU064A2201 with a weekly Urticaria Activity Score (UAS7)<16 after the follow-up period at Week 16 were further followed up without receiving LOU064 for up to 12 weeks (observational period). If there was a relapse (UAS7≥16 at least once), the 12-week observational period was terminated, and subjects entered the treatment period. Subjects who never relapsed within 12 weeks completed the study after the observational period without treatment.
Subjects who rolled over from CLOU064A2201 with a UAS7≥16 at Week 12 or Week 16, as well as those subjects who relapsed during the 12-week observational period, were treated with 100 mg LOU064 twice a day (b.i.d.) open-label for 52 weeks. No background medication with a second-generation H1-antihistamine was permitted up to Week 4 of the treatment period. Subjects who completed the treatment period or who discontinued treatment early were followed-up for a minimum duration of 4 weeks. Subjects who had a UAS7≤6 at Week 52 of the treatment period had their follow-up period extended until relapse (UAS7≥16) for up to a total of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: LOU064Participants with UAS7<16 at Week 16 of CLOU064A2201 were followed up to 12 weeks without receiving treatment (observational period). If participants relapsed (UAS7≥16 at least once), they were transitioned to the treatment period. Otherwise, they were discontinued from the study. Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered 100 mg of LOU064 b.i.d. open-label for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must provide written informed consent prior to any assessments.
- Participants must be willing and able to complete a daily symptom eDiary throughout the study and adhere to the study visit schedules.
- Participants transitioning from the CLOU064A2201 trial must have completed either the Week 12 visit (end of treatment period) or the Week 16 visit (end of follow-up period). They will be assigned to either the treatment period or the observational period based on their UAS7 score (average score from the 7 days prior to the respective visit) as follows:
Key exclusion criteria (11 listed)
- Participants with a clearly defined predominant or sole trigger for their chronic urticaria, such as chronic inducible urticaria (including symptomatic dermographism, cold-induced, heat-induced, solar-induced, pressure-induced, delayed pressure-induced, aquagenic-induced, cholinergic-induced, or contact-induced urticaria).
- Participants with other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
- Participants with any other skin disease associated with chronic itching that, in the opinion of the investigator, could affect the study evaluations and results, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis.
- Participants with a history or current diagnosis of ECG abnormalities that indicate a significant safety risk for their participation in the study, including:
- Concomitant clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia) and clinically significant second or third-degree AV block without a pacemaker.
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 |
|---|---|---|
| LOU064Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period. | Drug | All participants |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: From first dose of treatment up to 28 days after last dose, assessed up to 56 weeks
An AE refers to any undesirable medical occurrence, such as an unintended sign (including abnormal laboratory findings), symptom, or disease, experienced by a participant. Serious AEs (SAEs) is defined as any AE that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or any other medically significant condition. Treatment-emergent AEs were defined as AEs that either begin on the same day or after the first dose of study medication during the treatment period in the extension study or worsen on the same day or after the first dose of study medication in the extension study and within the minimum of either 28 days post last dose or the end of the study visit. The number of participants with treatment-emergent AEs was summarized.
5 secondary outcomes
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment Period
Time frame: Baseline, Week 4 of treatment period
Percentage of Participants With Well-controlled Disease (UAS7≤6) at Week 4 of the Treatment Period
Time frame: Week 4 of the treatment period
Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment Period
Time frame: Week 4 of the treatment period
Percentage of Participants With Well-controlled Disease (UAS7≤ 6) Overtime
Time frame: From baseline until Week 52 of the treatment period
Change From Baseline in UAS7 Overtime
Time frame: From baseline until Week 52 of the treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37866460Jain V, Gimenez-Arnau A, Hayama K, Reich A, Carr W, Tillinghast J, Dahale S, Lheritier K, Walsh P, Zharkov A, Hugot S, Haemmerle S. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol. 2024 Feb;153(2):479-486.e4. doi: 10.1016/j.jaci.2023.10.007. Epub 2023 Oct 20.
- Patient Lay Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceutical study director
Novartis Pharmaceutical
69 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LOU064 in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 69 sites in 15 countries.
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 6 inclusion and 11 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Japan, Canada, Spain, Hungary and 10 more countries. 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. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (AEs) (time frame: From first dose of treatment up to 28 days after last dose, assessed up to 56 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 NCT04109313, 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 20 Jun 2024.