Chronic Spontaneous Urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: LOU064
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: remibrutinib
Current Sponsor code: LOU064
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Male and female subjects aged =18 years of age 3. CSU diagnosis for = 6 months prior to screening 4. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the time of randomization as defined in the following: - The presence of itch and hives for =6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local treatment guidelines during this time period - UAS7 score (range 0-42) =16 and HSS7 score (range 0-21) = 8 during 7 days prior to randomization (Day 1) 5. Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 286 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any of the study treatments 2. Clearly defined, predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) 3. Other diseases with symptoms of urticaria or angioedema 4. Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results 5. Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C. 6. Pregnant or nursing (lactating) women 7. Women of child-bearing potential not using highly effective methods of contraception Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the dose-response relationship of LOU064 administered once or twice daily in subjects with CSU with respect to change from baseline in UAS7 at Week 4;Secondary Objective: To evaluate: - the efficacy of LOU064 compared to placebo with respect to change from baseline in UAS7 at Week 12 - the efficacy of LOU064 compared to placebo with respect to change from baseline in UAS7 over time - the efficacy of LOU064 compared to placebo with respect to achievement of complete clinical response (UAS7= 0) over time - the efficacy of LOU064 compared to placebo with respect to achievement of disease control (UAS7= 6) over time - the effect of LOU064 on angioedema (AAS7) with respect to the number of weeks with an AAS7= 0 response from baseline through Week 12 - the effect of LOU064 on disease-related quality of life with respect to achievement of a DLQI score of 0 or 1 at Week 4 and Week 12 - the effect of LOU064 on CSU related quality of life with respect to change from baseline in DLQI at Week 4 and Week 12 - the pharmacokinetics of LOU064 resulting from oral dosing at Week 4 and Week 12 - safety and tolerability of LOU064 in subjects with CSU;Primary end point(s): Change from baseline in weekly Urticaria Activity Score (UAS7);Timepoint(s) of evaluation of this end point: week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in UAS7 at Week 12 - Change from baseline in UAS7 over time - Complete absence of hives and itch, assessed as UAS7= 0 response over time - Disease control (UAS7= 6) over time - Cumulative number of weeks with an AAS7= 0 response between baseline and Week 12 - DLQI score of 0 or 1 at Week 4 and 12 - Change from baseline in DLQI score at Week 4 and 12 - Concentrations of LOU064 in blood and calculation of respective PK parameters at Week 4 and Week 12 - Safety endpoints will include but not be limited to: - Occurrence of treatment emergent adverse events during the study - Occurrence of treatment emergent serious adverse events during the study;Timepoint(s) of evaluation of this end point: week 4 and week 12 | — |
Countries
Argentina, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Japan, Netherlands, Poland, Russian Federation, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed