Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Condition: Chronic Inducible Urticaria
MeSH terms: Urticaria; Chronic Inducible Urticaria
Intervention: Ligelizumab; Placebo
Intervention description: Ligelizumab treated groups and arms; Placebo treated groups and arms
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: ligelizumab; anti-IgE; CINDU; chronic inducible urticaria; symptomatic dermographism; cold urticaria; cholinergic urticaria; urticaria; itch; hives

Summary:

      This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of
      ligelizumab in participants with chronic inducible urticaria who are inadequately controlled
      with H1-antihistamines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold
             urticaria or cholinergic urticaria for ≥ 4 months.

               -  Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic
                  urticaria) inadequately controlled with H1-AH at local label approved doses at
                  the time of randomization, as defined by all of the following:

               -  Positive response (i.e development of symptoms) to triggers despite treatment
                  with H1-AH

               -  Positive response (i.e. development of symptoms) to provocation test on day of
                  randomization

               -  Participants must be able to physically perform the protocol defined provocation
                  test specific to the participant's CINDU.

               -  Cholinergic urticaria participants must show sweating in performing the
                  pulse-controlled ergometry test on day of randomization. Participants with
                  anhidrosis must not be included.

               -  Willing and able to complete a daily symptom eDiary as per protocol requirement
                  and adhere to the study visit schedules

        Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs or its components or to drugs of
             similar chemical classes or to the provocation test or items used in provocation tests

               -  Participants who have concomitant CSU at screening

               -  Participants who have a familial form of the target CINDU that is being
                  considered for the participant's inclusion in this study

               -  Participants having a more defined other form of inducible urticaria than the
                  target CINDU that is being considered for the participant's inclusion in this
                  study

               -  Diseases, other than chronic inducible urticaria, with urticarial or angioedema
                  symptoms such as urticarial vasculitis, erythema multiforme, cutaneous
                  mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg,
                  due to C1 inhibitor deficiency).

               -  Any other skin disease associated with chronic itching that might influence, in
                  the investigator's opinion, the study evaluations and results (eg, atopic
                  dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
                  or skin diseases associated with only wheals and no itch e.g asymptomatic
                  dermographism

               -  Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies