Clinical trial NCT05024058: Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Official title: A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Inducible Urticaria
Keywords: ligelizumab
anti-IgE
CINDU
chronic inducible urticaria
symptomatic dermographism
cold urticaria
cholinergic urticaria
urticaria
itch
hives
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.

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

Primary outcomes:
measure: Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
timeFrame: Baseline, Week 12
measure: Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria
timeFrame: Baseline, Week 12
measure: Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0
timeFrame: Week 12
measure: Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism
timeFrame: Baseline, Week 12
measure: Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest
timeFrame: Baseline, Week 12
measure: Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria
timeFrame: Baseline, Week 12
measure: Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0
timeFrame: Week 12
measure: Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0
timeFrame: Week 12
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: North Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Murray
country: United States
facility: Novartis Investigative Site
state: Utah
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
state: Hajdu Bihar
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov On Don
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Stavropol
country: Russian Federation
facility: Novartis Investigative Site
city: Kezmarok
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
References: