The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
Signed informed consent must be obtained prior to participation in the study.
Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization
Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa),
food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant
hereditary or acquired angioedema.
Parallel
Remibrutinib
Drugtablets
Placebo
Drugtablets
Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD)
To investigate the efficacy of remibrutinib versus placebo for the most bothersome symptom in CINDU patients. The USDD was developed to assess daily exposure and avoidance of triggers, severity of urticaria symptoms (including NRS for pain itch and burning). On the first day of completion, the participants will be asked which symptom (itch, pain, and burning) is the most bothersome symptom of urticaria.
Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores
To investigate the impact of remibrutinib versus placebo on urticaria symptom control. The UCT is a 4-item PRO measure developed to assess disease control in patients with CU specifically CINDU and CSU. It has a 7-day recall period and participants respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Participants with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control.
Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores
To investigate the impact of remibrutinib versus placebo on urticaria symptom control and quality of life. The UCT is a 4-item PRO measure developed to assess disease control in patients with CU specifically CINDU and CSU. It has a 7-day recall period and participants respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Participants with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control.
Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1
To investigate the impact of remibrutinib versus placebo on urticaria symptom control and quality of life. The DLQI is a 10-item (grouped in 6 domains) dermatology-specific Quality of Life (QoL) measure. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse dermatology QoL). For DLQI, the domain scores are calculated for: Symptoms and Feelings (0-6), Daily Activities (0-6), Leisure (0-6), Work and School (0-3), Personal Relationships (0-6) and Treatment (0-3). A DLQI score of \> 10 is relevant for a very large impact on patients' life and justification for a biologic prescription for example in psoriasis.
Absolute change from baseline in USDD weekly component scores; this includes the change in itch, pain and burning numeric rating scale (NRS) from baseline.
To investigate the change in symptoms in participants treated with remibrutinib versus placebo. The USDD was developed to assess daily exposure and avoidance of triggers, severity of urticaria symptoms (including NRS for pain itch and burning). On the first day of completion, the participants will be asked which symptom (itch, pain, and burning) is the most bothersome symptom of urticaria.
Number of Participants With Adverse Events of Special Interest (AESI)
To investigate the safety of remibrutinib versus placebo in patients with Chronic Urticaria
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