Chronic Spontaneous UrticariaPhase 3NCT05677451
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
A Phase 3 study testing LOU064 (blinded) in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 49 sites in 17 countries.
Trial summary
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- LOU064 (blinded)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 49 sitesin 17 countries
- Study dates
- 11 Jul 2023to 30 Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female adolescent participants aged >= 12 to < 18 years of age at the time of signing the informed consent
- CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)
- Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:
- The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines
- UAS7 score (range 0 - 42) >= 16, ISS7 score (range 0 - 21) >= 6 and HSS7 score (range 0 - 21) >= 6 during the 7 days prior to randomization (Day 1)
- Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants' medical history)
Who cannot join
- Previous use of remibrutinib or other BTK inhibitors
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited
- History or current hepatic disease
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant
Show all 11Show fewer
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
- Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
- Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria
- Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
49 sites in 17 countries.
49 sites in 17 countries
United States11 sites
Kern Research
Bakersfield, California, 93301
Treasure Valley Medical Research
Boise, Idaho, 83706
Endeavor Health
Glenview, Illinois, 60077
Pediatric Dermatology of Miami at the Pediatric CoE
Miami, Florida, 33156
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, 73120
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, 42301
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
RFSA Dermatology
San Antonio, Texas, 78213
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Allergy Associates of Utah
Sandy City, Utah, 84093
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
Japan5 sites
Novartis Investigative Site
Itabashi-ku, Tokyo, 1738610
Novartis Investigative Site
Izumo, Shimane, 6938501
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 8613106
Novartis Investigative Site
Kitakyushu, Fukuoka, 8078556
Novartis Investigative Site
Sakai, Osaka, 5938324
Argentina4 sites
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF
Novartis Investigative Site
CABA, C1181ACH
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DEJ
Novartis Investigative Site
San Miguel de Tucumán, T4000AXL
China4 sites
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Beijing, 100069
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Guangzhou, Guangdong, 510091
Germany3 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Novartis Investigative Site
Tübingen, 72076
Italy3 sites
Novartis Investigative Site
Florence, FI, 50139
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Siena, SI, 53100
Thailand3 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Turkey (Türkiye)3 sites
Novartis Investigative Site
Adana, 01330
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
Novartis Investigative Site
Istanbul, Fatih, 34093
United Kingdom3 sites
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Peterborough, Cambridgeshire, PE3 9GZ
Novartis Investigative Site
Southampton, SO16 6YD
South Africa2 sites
Novartis Investigative Site
Cape Town, 7925
Novartis Investigative Site
Pretoria, Gauteng, 0181
Spain2 sites
Novartis Investigative Site
Esplugues, Barcelona, 08950
Novartis Investigative Site
Valencia, 46014
Chile1 site
Novartis Investigative Site
Santiago, Santiago Metropolitan, 8420383
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
The purpose of this trial is:
- to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
- to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
- to collect safety data in this population for up to three years after the last dose of study treatment
Read the detailed description
This trial consists of 3 different periods:
- the "core period", which is randomized and double-blind, during which 2/3 participants will receive remibrutinib and 1/3 will receive placebo for 24 weeks. Total duration: approximately 32 weeks (10 site visits).
- an optional "open-label extension (OLE) period" proposed to all participants who completed 24 weeks of treatment of the "core period" and all scheduled assessments planned at week 24 visit . Depending on their CSU symptoms (as assessed by the doctor), participants will either receive remibrutinib for 24 weeks, or enter an observational treatment-free period for 1 year. If the CSU symptoms return during the observational period, the participants can switch to the treatment period at any time (decided by the doctor). At the end of the 24-week treatment period, if CSU is controlled, participants will enter the 1-year observational period, otherwise, they can continue with another cycle of 24-week remibrutinib treatment. The number of remibrutinib treatment or observational cycles will be limited to 6 times each. Total duration: from 1 year to approximately 3 years, and number of visits: from 3 to 15 (depending on the CSU symptoms).
- an optional "long-term treatment-free follow-up period" proposed to all participants who completed at least 4 months treatment in the "OLE period". No treatment will be given. Duration: 3 years with 1 site visit and up to 4 phone call follow-up visits.
The primary clinical question of interest is what is the effect of remibrutinib treatment versus placebo on the change from baseline in UAS7, ISS7 and HSS7 scores after 12 weeks of treatment
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- LOU064 (blinded), placebo
- Keywords
- BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity 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.
LOU064 (blinded)Drug
Also called remibrutinib
LOU064 (blinded) active treatment
placeboDrug
matching active drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: LOU064 (blinded) | Experimental | LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks. Receives: Drug: LOU064 (blinded) |
| Arm 2: LOU064 placebo (blinded) | Placebo comparator | LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in UAS7
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0.
Negative change from baseline indicates improvement.
Measured: Baseline, week 12
Change fron baseline in ISS7
Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).
Negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Change from baseline in HSS7
Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours).
Negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Secondary outcomes (11)
Cmax of remibrutinib
The maximum (peak) observed blood drug concentration after single dose administration
Measured: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
Tmax of remibrutinib
The time to reach maximum (peak) blood drug concentration after single dose administration
Measured: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
AUClast of remibrutinib
The Area Under the Curve (AUC) from pre-dose to the last measurable concentration sampling time
Measured: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
Absolute change from baseline in ISS7
Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).
Negative change from baseline indicates improvement.
Measured: Baseline - Week 12
Absolute change from baseline in HSS7
Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours).
Negative change from baseline indicates improvement.
Measured: Baseline - Week 12
Achievement of UAS7 ≤ 6 (yes/no)
Disease activity control is defined as UAS7 ≤ 6. The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42.
Measured: Week 12 and over time
Achievement of UAS7 = 0 (yes/no)
Complete absence of hives and itch is defined as UAS7 = 0. The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42.
Measured: Week 12 and over time
Absolute change from baseline in CDLQI score
The Children Dermatology life Quality Index (CDLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: Week 12
Number of weeks without angioedema, assessed by the cumulative number of weeks with an AAS7 = 0 response
Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-105 where higher scores indicate increased angioedema activity.
Measured: baseline - Week 12
Occurrence of treatment-emergent adverse events (AE) and serious adverse events (SAE) during the core period
To demonstrate the safety and tolerability of remibrutinib by assessing occurrence of treatment emergent adverse events and serious adverse events during the core period of the study.
Measured: 28 weeks
Occurrence of treatment emergent AEs, and SAEs during the Open Label Extension (OLE) period
To demonstrate the safety and tolerability of remibrutinib by assessing occurrence of treatment emergent adverse events and serious adverse events during the OLE period of the study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start11 Jul 2023
- Primary completion3 Nov 2026 (estimated)
- Study completion30 Mar 2032 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677451
- Sponsor's protocol ID
- CLOU064F12301
- Other IDs
- 2022-502159-78-00
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
- ClinicalTrials.gov ID
- NCT05677451
- Acronym / sponsor ID
- CLOU064F12301
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 30 Mar 2032 (estimated)
- First posted
- 10 Jan 2023 (actual)
- 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.
The purpose of this trial is:
- to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
- to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
- to collect safety data in this population for up to three years after the last dose of study treatment
Detailed description
This trial consists of 3 different periods:
- the "core period", which is randomized and double-blind, during which 2/3 participants will receive remibrutinib and 1/3 will receive placebo for 24 weeks. Total duration: approximately 32 weeks (10 site visits).
- an optional "open-label extension (OLE) period" proposed to all participants who completed 24 weeks of treatment of the "core period" and all scheduled assessments planned at week 24 visit . Depending on their CSU symptoms (as assessed by the doctor), participants will either receive remibrutinib for 24 weeks, or enter an observational treatment-free period for 1 year. If the CSU symptoms return during the observational period, the participants can switch to the treatment period at any time (decided by the doctor). At the end of the 24-week treatment period, if CSU is controlled, participants will enter the 1-year observational period, otherwise, they can continue with another cycle of 24-week remibrutinib treatment. The number of remibrutinib treatment or observational cycles will be limited to 6 times each. Total duration: from 1 year to approximately 3 years, and number of visits: from 3 to 15 (depending on the CSU symptoms).
- an optional "long-term treatment-free follow-up period" proposed to all participants who completed at least 4 months treatment in the "OLE period". No treatment will be given. Duration: 3 years with 1 site visit and up to 4 phone call follow-up visits.
The primary clinical question of interest is what is the effect of remibrutinib treatment versus placebo on the change from baseline in UAS7, ISS7 and HSS7 scores after 12 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: LOU064 (blinded) | Experimental | Drug: LOU064 (blinded)LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks. |
| Arm 2: LOU064 placebo (blinded) | Placebo comparator | Drug: placeboLOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female adolescent participants aged >= 12 to < 18 years of age at the time of signing the informed consent
- CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)
- Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:
- The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines
- UAS7 score (range 0 - 42) >= 16, ISS7 score (range 0 - 21) >= 6 and HSS7 score (range 0 - 21) >= 6 during the 7 days prior to randomization (Day 1)
Key exclusion criteria (11 listed)
- Previous use of remibrutinib or other BTK inhibitors
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited
- History or current hepatic disease
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 |
|---|---|---|
| LOU064 (blinded)Also: remibrutinibLOU064 (blinded) active treatment | Drug | Arm 1: LOU064 (blinded) |
| placebomatching active drug | Drug | Arm 2: LOU064 placebo (blinded) |
Primary outcome
Change from baseline in UAS7
Time frame: Baseline, week 12
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Negative change from baseline indicates improvement.
Change fron baseline in ISS7
Time frame: Baseline, Week 12
Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement.
Change from baseline in HSS7
Time frame: Baseline, Week 12
Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Negative change from baseline indicates improvement.
11 secondary outcomes
Cmax of remibrutinib
Time frame: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
Tmax of remibrutinib
Time frame: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
AUClast of remibrutinib
Time frame: At Week 12, before study drug intake, then after 30 min, 1 h, 2h, 3h and 4 h after study drug intake
Absolute change from baseline in ISS7
Time frame: Baseline - Week 12
Absolute change from baseline in HSS7
Time frame: Baseline - Week 12
Achievement of UAS7 ≤ 6 (yes/no)
Time frame: Week 12 and over time
Achievement of UAS7 = 0 (yes/no)
Time frame: Week 12 and over time
Absolute change from baseline in CDLQI score
Time frame: Week 12
Number of weeks without angioedema, assessed by the cumulative number of weeks with an AAS7 = 0 response
Time frame: baseline - Week 12
Occurrence of treatment-emergent adverse events (AE) and serious adverse events (SAE) during the core period
Time frame: 28 weeks
Occurrence of treatment emergent AEs, and SAEs during the Open Label Extension (OLE) period
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
Related trials for Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
Chronic Spontaneous Urticaria (CSU)
RecruitingPhase 3
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Chronic Spontaneous Urticaria
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 Pharmaceuticals study director
Novartis Pharmaceuticals
49 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LOU064 (blinded) in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 49 sites in 17 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Japan, Argentina, China, Germany and 12 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. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in UAS7 (time frame: Baseline, week 12). The study lists 3 primary outcomes in all. 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 15 Oct 2026.