This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: LOU064 Arm 1; LOU064 Arm 2; LOU064 Arm 3; LOU064 Arm 4; LOU064 Arm 5; LOU064 Arm 6; Placebo arm
Intervention description: 10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 10mg bid of LOU064 orally, twice daily from Day 1 to 85; 25 mg bid of LOU064 orally, twice daily from Day 1 to 85; 100 mg bid of LOU064 orally, twice daily from Day 1 to 85; Matching placebo, orally, twice daily from Day 1 to 85
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebocontrolled study investigating the efficacy, safety and tolerability of 6 dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. Study duration was 18 weeks (2 weeks of screening period; 12 weeks of treatment period and a 4 weeks follow-up period).
Study had 7 arms: 10 mg LOU064 q.d.; 35 mg LOU064 q.d.; 100 mg LOU064 q.d.; 10 mg LOU064 b.i.d.; 25 mg LOU064 b.i.d.; 100 mg LOU064 b.i.d.; and Placebo
Throughout study, subjects were treated with a 2nd generation H1-antihistamine at a locally approved licensed posology ("background medication"). Subjects could take an additional second generation H1-antihistamine that was eliminated primarily via renal excretion (e.g. cetirizine, levocetirizine or bilastine) as rescue medication. Eligible subjects could roll over to extension at Wk 12 or Wk 16
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: BTK inhibitor; Urticaria Activity Score; Angioedema Activity Score; CSU

Summary:

      This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding
      study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria
      (CSU) patients inadequately controlled by H1-antihistamines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged ≥18 years of age

          -  CSU diagnosis for ≥ 6 months prior to screening

          -  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)

          -  Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the
             duration of the study

        Exclusion Criteria:

          -  Hypersensitivity to any of the study treatments

          -  Clearly defined predominant or sole trigger of their chronic urticaria (chronic
             inducible urticaria)

          -  Other diseases with symptoms of urticaria or angioedema

          -  Other skin disease associated with chronic itching that might influence in the
             investigators opinion the study evaluations and results,

          -  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.

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential not using highly effective methods of contraception