An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: LOU064
Intervention description: Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic spontaneous urticaria; BTK Inhibitor; Long term safety; Urticaria activity score

Summary:

      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)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants must provide written informed consent prior to any assessments.

          -  Participants must be willing and able to complete a daily symptom eDiary throughout
             the study and adhere to the study visit schedules.

          -  Participants transitioning from the CLOU064A2201 trial must have completed either the
             Week 12 visit (end of treatment period) or the Week 16 visit (end of follow-up
             period). They will be assigned to either the treatment period or the observational
             period based on their UAS7 score (average score from the 7 days prior to the
             respective visit) as follows:

               1. Participants transitioning at Week 12 of CLOU064A2201 with a UAS7 score of ≥16
                  will be allocated to the treatment period.

               2. Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of ≥16
                  will be allocated to the treatment period.

               3. Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of <16
                  will be allocated to the observational period.

        Key Exclusion Criteria:

          -  Participants with a clearly defined predominant or sole trigger for their chronic
             urticaria, such as chronic inducible urticaria (including symptomatic dermographism,
             cold-induced, heat-induced, solar-induced, pressure-induced, delayed pressure-induced,
             aquagenic-induced, cholinergic-induced, or contact-induced urticaria).

          -  Participants with other diseases presenting with urticaria or angioedema symptoms,
             including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema
             multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.

          -  Participants with any other skin disease associated with chronic itching that, in the
             opinion of the investigator, could affect the study evaluations and results, such as
             atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or
             psoriasis.

          -  Participants with a history or current diagnosis of ECG abnormalities that indicate a
             significant safety risk for their participation in the study, including:

          -  Concomitant clinically significant cardiac arrhythmias (e.g., sustained ventricular
             tachycardia) and clinically significant second or third-degree AV block without a
             pacemaker.

          -  History of familiar long QT syndrome or a known family history of Torsades de Pointes.

          -  Resting heart rate (as determined by physical exam or 12-lead ECG) below 50 bpm.

          -  Resting QTcF interval ≥450 msec (in males) or ≥460 msec (in females) at day 1 of the
             treatment period or inability to determine the QTcF interval.

          -  Use of agents known to prolong the QT interval, unless they can be permanently
             discontinued for the duration of the study.

          -  Participants with a significant risk of bleeding or coagulation disorders.

          -  Participants with a known or suspected history of an ongoing, chronic, or recurrent
             infectious disease, including but not limited to opportunistic infections (e.g.,
             tuberculosis, atypical mycobacterioses, listeriosis, or aspergillosis), HIV, or
             Hepatitis B/C.