Chronic Inducible Urticaria MedDRA version: 20.0 Level: PT Classification code 10009869 Term: Cold urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10008675 Term: Cholinergic urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 23.0 Level: LLT Classification code 10012521 Term: Dermographism System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained before any assessment is performed. 2. Participant’s parent’s or legal guardian’s signed informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed. 3. Male and female participants = 12 years of age at the time of screening. 4. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for = 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)). 5. 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 6. Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU. 7. Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included. 8. Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules. Are the trial subjects under 18? yes Number of subjects for this age range: 22 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days for small molecules prior to the screening visit or until the expected pharmacodynamic effect has returned to baseline for biologics, whichever is longer. 2. History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests 3. Participants who have any concomitant CSU at screening 4. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study 5. 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 6. 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). 7. 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 8. Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies 9. Female participants, including adolescent females of 12 to less than 18 years of age, of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to a standardized provocation test for each CINDU subtype.;Secondary Objective: To demonstrate superiority of ligelizumab versus placebo with regard to proportion of participants with a complete response after standardized provocation test. To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation test. To assess the safety of ligelizumab.;Primary end point(s): Symptomatic Dermographism Change from baseline in Total Fric Score (TFS) at Week 12 in response to FricTest® 4.0 Cold Urticaria Change from baseline in critical temperature threshold (CTT) at Week 12 in response to the TempTest® 4.0 Cholinergic Urticaria Change from baseline in itch numerical rating scale (NRS) at Week 12 in response to the pulse-controlled ergometry test. ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Symptomatic Dermographism Proportion of participants with complete response in FricTest® at Week 12 Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline Cold Urticaria Proportion of participants with complete response in TempTest® at Week 12 Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline Cholinergic Urticaria Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 12 Proportion of participants with physician global assessment of severity of hives=0 following the pulse-controlled ergometry test at Week 12 Safety endpoints will include but not be limited to: •Occurrence of treatment emergent adverse events (serious and non-serious) during the study •Occurrence of treatment emergent adverse events during the study leading to discontinuation of study treatment •Occurrence of treatment emergent adverse events of interest listed as either identified or potential risks, during the study •Changes in safety parameters ;Timepoint(s) of evaluation of this end point: At 12 Weeks and over time | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Jordan, Korea, Republic of, Lebanon, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Viet Nam
Contacts
Public ContactMedical Information Desk
Novartis Pharma Services Inc., Podružnica v Sloveniji
Outcome results
None listed