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 numbe
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent must be obtained before any assessment is performed. - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. - Subjects must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) of CLOU064A2201 and will be allocated to the treatment period or the observational period of CLOU064A2201E1 based on the UAS7 score (of the 7 days prior to the respective visit) as follows: a) Subjects rolling over at Week 12 of CLOU064A2201 with a UAS7=16 will be allocated to the Treatment period (note: subjects with UAS7=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to enrollment or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations. - History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. - Subjects 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 urticaria, or acquired/drug-induced urticaria - Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis - History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study - Patients/subjects taking medications prohibited by the protocol - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. - Pregnant or nursing (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study medication. - Sexually active males must use a condom during intercourse while taking drug and for 7 days after stopping study medication and should not father a child in this period. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. - Major surgery within 8 weeks prior to enrollment or surgery planned prior to end of the treatment period. - History of live attenuated vaccine within 6 weeks prior to enrollment or requirement to receive these vaccinations at any time during study drug treatment - Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation. - Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids. - Hematology parameters at last visit before Day 1 of the Treatment period (either last available value from CLOU064A2201 or most recent value taken during observational period): Hemoglobin: < 10 g/dl; Platelets: < 100 000/mm3; White blood cells: < 3 000/mm3; Neutrophils: < 1 500/mm3; - Significant bleeding risk or coagulation disorders - History of gastrointestinal bleeding, eg in association wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of LOU064 in patients with CSU who have participated in CLOU064A2201;Secondary Objective: - To evaluate the efficacy of LOU064 when given without H1-antihistamines in patients with CSU who have participated in CLOU064A2201 with respect to change from baseline in UAS7, achieving controlled disease (defined by a UAS7=6), and achieving complete response (defined by a UAS7=0) at Week 4 of treatment. - To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in CLOU064A2201 with respect to maintaining or achieving controlled disease (defined by a UAS7=6) over time. - To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in CLOU064A2201 with respect to change from baseline in UAS7 over time.;Primary end point(s): Safety endpoints will include but not be limited to: occurrence of treatment emergent (serious and non-serious) adverse events during the extension study;Timepoint(s) of evaluation of this end point: 56 weeks (treatment plus follow-up period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in UAS7 at Week 4 2. UAS7=6 response at Week 4 3. UAS7=0 response at Week 4 4. UAS7= 6 response over time 5. Change from baseline in UAS7 over time;Timepoint(s) of evaluation of this end point: at Week 4 and over time | — |
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