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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
39
Ligelizumab treated groups and arms
Placebo treated groups and arms
Novartis Investigative Site
Evansville, Indiana, United States
Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed
Time frame: Baseline, Week 12
Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria
The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.
Time frame: Baseline, Week 12
Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria
Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")
Time frame: Baseline, Week 12
Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0
Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12
Time frame: Week 12
Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism
Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
North Charleston, South Carolina, United States
Novartis Investigative Site
El Paso, Texas, United States
Novartis Investigative Site
Murray, Utah, United States
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Debrecen, Hajdú-Bihar, Hungary
Novartis Investigative Site
Pécs, Hungary
Novartis Investigative Site
Szeged, Hungary
...and 14 more locations
Time frame: Baseline, Week 12
Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest
The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.
Time frame: Baseline, Week 12
Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria
Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")
Time frame: Baseline, Week 12
Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0
Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")
Time frame: Week 12
Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0
Physician global assessment of severity of hives PGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives)
Time frame: Week 12