Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

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

ClinicalTrials.gov Identifier: NCT05024058

Novartis Reference Number: CQGE031E12301

Last Update: May 11, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is 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

Condition 
Chronic Inducible Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Nov 16, 2021
Completion date 
Dec 27, 2024
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Ligelizumab
Ligelizumab treated groups and arms
Other
Placebo
Placebo treated groups and arms

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
Recruiting
Huntington Beach, 92647
California
United States
Novartis Investigative Site
Recruiting
Orlando, 32806
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
Recruiting
Boise, 83706
Idaho
United States
Novartis Investigative Site
Recruiting
Evansville, 47713
Indiana
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
Novartis Investigative Site
Recruiting
Ocean City, 07712
New Jersey
United States
Novartis Investigative Site
Recruiting
Toledo, 43617
Ohio
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15241
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3002
Victoria
Australia
France
Novartis Investigative Site
Recruiting
Clermont Ferrand, 63003
-
France
Novartis Investigative Site
Recruiting
La Tronche, 38700
-
France
Novartis Investigative Site
Recruiting
Montpellier cedex 5, 34295
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
Recruiting
Toulouse, 31400
-
France
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4026
Hajdu Bihar
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7632
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Italy
Novartis Investigative Site
Recruiting
Firenze, 50141
FI
Italy
Novartis Investigative Site
Recruiting
Siena, 53100
SI
Italy
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3584CX
-
Netherlands
Russian Federation
Novartis Investigative Site
Recruiting
Izhevsk, 426061
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Rostov on Don, 344022
-
Russian Federation
Novartis Investigative Site
Recruiting
Smolensk, 214019
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 191015
-
Russian Federation
Novartis Investigative Site
Recruiting
Stavropol, 355000
-
Russian Federation
Singapore
Novartis Investigative Site
Recruiting
Singapore, 308205
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 529889
-
Singapore
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 85101
-
Slovakia
Novartis Investigative Site
Recruiting
Kezmarok, 060 01
-
Slovakia
Novartis Investigative Site
Recruiting
Nove Zamky, 940 34
-
Slovakia
Novartis Investigative Site
Recruiting
Svidnik, 08901
-
Slovakia
Novartis Investigative Site
Recruiting
Zilina, 010 01
-
Slovakia
Slovenia
Novartis Investigative Site
Recruiting
Golnik, 4204
-
Slovenia
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
Recruiting
Esplugues de Llobregat, 08950
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
Las Palmas de Gran Canaria, 35010
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Tao Yuan, 333
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Denizli, 20070
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34010
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34093
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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