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A 12-week randomized, participant and investigator blinded, placebo-controlled, exploratory study in adult participants with Chronic Urticaria to assess the efficacy and safety and explore the Mechanism of Action of remibrutinib (LOU064)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516355-41-00
Acronym
CLOU064M12101
Enrollment
39
Registered
2025-05-19
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inducible urticaria and Chronic Spontaneous Urticaria

Brief summary

Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6, Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6

Detailed description

Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12, Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12, Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline., Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs)

Interventions

DRUGLOU064
DRUG-
DRUGPlacebo to LOU064 Film-coated tablet

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6, Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6

Secondary

MeasureTime frame
Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12, Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12, Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline., Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs)

Countries

France, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026