Adults 18 to 99, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (AEs)Primary· 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
AEs
Group
Value
95% CI
Treated Cohort
139
Deaths
Group
Value
95% CI
Treated Cohort
0
Non-fatal Serious AEs (SAEs)
Group
Value
95% CI
Treated Cohort
6
SAE(s)
Group
Value
95% CI
Treated Cohort
6
Discontinued treatment due to any AE(s)
Group
Value
95% CI
Treated Cohort
11
Discontinued treatment due to any SAE(s)
Group
Value
95% CI
Treated Cohort
2
Treatment interruption due to AE(s)
Group
Value
95% CI
Treated Cohort
13
Treatment interruption due to SAE(s)
Group
Value
95% CI
Treated Cohort
1
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment PeriodSecondary· Baseline, Week 4 of 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 neede
Group
Value
95% CI
Treated Cohort
-17.58
± 13.400
Percentage of Participants With Well-controlled Disease (UAS7≤6) at Week 4 of the Treatment PeriodSecondary· 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 need
Group
Value
95% CI
Treated Cohort
51.0
44.9 – 57.1
Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment PeriodSecondary· 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 need
Group
Value
95% CI
Treated Cohort
27.3
22.2 – 33.1
Percentage of Participants With Well-controlled Disease (UAS7≤ 6) OvertimeSecondary· From baseline until Week 52 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 need
Baseline
Group
Value
95% CI
Treated Cohort
1.0
0.2 – 3.5
Week 1
Group
Value
95% CI
Treated Cohort
37.4
31.4 – 43.8
Week 4
Group
Value
95% CI
Treated Cohort
52.7
46.4 – 58.8
Week 12
Group
Value
95% CI
Treated Cohort
56.6
50.1 – 63.0
Week 20
Group
Value
95% CI
Treated Cohort
62.7
56.1 – 68.9
Week 28
Group
Value
95% CI
Treated Cohort
68.5
61.9 – 74.5
Week 40
Group
Value
95% CI
Treated Cohort
66.5
59.6 – 72.7
Week 52
Group
Value
95% CI
Treated Cohort
68.0
61.1 – 74.3
Change From Baseline in UAS7 OvertimeSecondary· From baseline until Week 52 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 need
Week 1
Group
Value
95% CI
Treated Cohort
-14.76
± 11.502
Week 4
Group
Value
95% CI
Treated Cohort
-17.58
± 13.400
Week 12
Group
Value
95% CI
Treated Cohort
-19.37
± 12.502
Week 20
Group
Value
95% CI
Treated Cohort
-20.61
± 11.634
Week 28
Group
Value
95% CI
Treated Cohort
-21.54
± 11.525
Week 40
Group
Value
95% CI
Treated Cohort
-21.25
± 11.400
Week 52
Group
Value
95% CI
Treated Cohort
-21.82
± 10.699
Adverse events — posted to ClinicalTrials.gov
Time frame: In the Treated cohort, treatment-emergent AEs were collected from first dose of treatment up to 28 days post last dose, up to 56 weeks; and deaths were collected from first dose of treatment until end of study, assessed up to 68 weeks. In the Treatment-free cohort, AEs and deaths were collected from start of observation period until relapse (UAS7≥16) or end of observation period, up to 12 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment-free Cohort (Observational Period)
Serious: 1/68 (1%)
Deaths: 0/68
Treated Cohort (Treatment+Follow-up Period)
Serious: 6/194 (3%)
Deaths: 0/194
Serious adverse events (7 terms)
Reaction
System
Treatment-free Cohort (Obs…
Treated Cohort (Treatment+…
COVID-19 pneumonia
Infections and infestations
—
—
Melaena
Gastrointestinal disorders
—
—
Chest pain
General disorders
—
—
Appendicitis
Infections and infestations
—
—
Tibia fracture
Injury, poisoning and procedural complications
—
—
Ovarian cyst
Reproductive system and breast disorders
—
—
Superficial spreading melanoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05795153 — A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous
· Phase 3
· completed
NCT05048342 — A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-ant
· Phase 3
· completed
NCT03918980 — Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064
· Phase 1
· completed
Other recruiting trials for Chronic Spontaneous Urticaria
Currently open trials in the same condition.
NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont
· recruiting
NCT07358364 — Remibrutinib in Real-world Clinical Practice
· recruiting
NCT07358780 — Remibrutinib in Real-world Clinical Practice - a US Sub-study
· recruiting
NCT07408219 — A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
· recruiting
NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
· Phase 2
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04109313.