Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria (MASTER)
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|ClinicalTrials.gov Identifier: NCT04513548|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : June 30, 2022
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria.
The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. In Part 1, approximately 20 healthy volunteers and patients with chornic urticaria will be enrolled. In Part 2 approximately 48 patients with chronic urticaria (spontaneous chronic urticaria, cholinergic urticaria or cold urticaria). Part 1 consists of a screening period up 2 weeks and a visit with skin tests; there is no treatment taken in Part 1. Part 2 is randomized, subject, investigator and sponsor blinded. It consists of a screening period up to 4 weeks, a 16 week treatment period and a 12-week follow-up period after last treatment. A follow-up call at Week 32 will be performed via telephone.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria Cholinergic Urticaria Cold Urticaria||Drug: Ligelizumab Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Part 1 is not masked Part 2 is masked|
|Primary Purpose:||Basic Science|
|Official Title:||A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator and Sponsor-blinded, Placebo Controlled, Study (Part 2) to Assess the MechAniSm of acTion of ligElizumab (QGE031) in Patients With Chronic uRticaria (MASTER)|
|Actual Study Start Date :||August 5, 2020|
|Estimated Primary Completion Date :||March 13, 2023|
|Estimated Study Completion Date :||March 14, 2023|
One injection every four weeks
|Placebo Comparator: Placebo||
One injection every four weeks
- Part 1: Wheal and erythema size after skin prick test with several different ciprofloxacin and icatibant concentrations. [ Time Frame: At Day 1 ]Size of the wheal and erythema in mm will be measured after the skin prick and intradermal tests are performed. Different dilution steps will be applied (to differentiate Chronic Spontaneous Urticaria patients and healthy controls) for ciprofloxacin and icatibant to determine the conditions to be used in Part 2.
- Part 2: Change in wheal size after challenge procedure from Day 1 (pre-dose) to week 16. [ Time Frame: Day 1 and Week 16 ]Size of wheal in mm2 after skin prick test and autologous serum skin test will be measured.
- Part 2: Urticaria Control Test [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 ]The Urticaria Control Test (UCT) is a questionnaire that assesses the extent of the disease control over the previous 4 weeks. It consists of 4 questions, each rated from 0 to 4 points. Subsequently, the scores for all 4 questions are summed up. The minimum and maximum UCT scores are 0 and 16, with 12 points or higher indicating controlled disease, and 16 points indicating complete disease control.
- Part 2: Weekly Urticaria Activity Score [ Time Frame: Throughout the study (to 28 weeks) ]Chronic Spontaneous Urticaria (CSU) patients: The Urticaria Activity Score (UAS) is evaluated in the screening period and throughout the study. It records each morning and evening on a daily basis symptoms of itch and hives into a patient diary. The UAS is a composite score with numeric severity intensity ratings on a scale of 0 - 3 for the number of wheals (hives) and the itch intensity. The UAS7 is the sum of the daily UAS scores over 7 days. UAS7 values range from 0 to 42, with higher values indicate higher disease activity.
- Part 2: Cholinergic Urticaria Activity score [ Time Frame: Day 1 to Week 28 ]Cholinergic urticaria patients: Cholinergic Urticaria Activity score (CholUAS) is a questionnaire that records each evening on a daily basis symptoms of itch and hives and the general assessment of disease severity into a patient diary. The CholUAS is a composite score with numeric ratings on a scale of 0 - 3 for the intensity of wheals (hives), the itch intensity, and the overall assessment of the disease severity. The total score is a sum of scores multiplied with the score for the trigger. The CholUAS7 is the sum of the daily CholUAS scores over 7 days. Higher values indicate a higher disease activity.
- Part 2: Chronic Urticaria Quality of Life questionnaire [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 ]CSU patients: The Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). with a total score of 0 to 100 %. Higher scores indicate higher impairment in quality of life.
- Part 2: Angioedema control test [ Time Frame: Day 1, Week 16, Week 28 ]CSU patients with angioedema: Angioedema Control Test (AECT) is a questionnaire that assesses the extent of the symptom control (angioedema). It consists of 4 questions, each rated from 0 to 4 points. Subsequently, the scores for all 4 questions are summed up. The minimum and maximum AECT scores are 0 and 16, with 10 points or higher indicating controlled disease, and 16 points indicating complete disease control.
- Part 2: Cholinergic Urticaria Quality of Life questionnaire [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 ]Cholinergic patients: The Cholinergic Urticaria Quality of Life questionnaire (Chol-Q2oL) is a questionnaire that measures the relative burden of cholinergic urticaria on subjective well-being. The questionnaire consists of 28 items, each item being scored between 0 and 4. Higher scores indicate higher impairment in quality of life.
- Part 2: Provocation test for cholinergic patients [ Time Frame: Day 1, Week 4, Week 16, Week 28 ]Cholinergic patients: Time from onset of sweating and urticaria symptoms after an exercise on a stationary bicycle.
- Part 2: Temperature trigger test for cold urticaria patients [ Time Frame: Day 1, Week 4, Week 16, Week 28 ]Cold urticaria patients: The temperature that will provoke the formation of wheals will be assessed.
- Part 2: Safety and tolerability [ Time Frame: Throughout the study (to 28 weeks) ]Number of patients with adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513548
|Novartis Investigative Site|
|Berlin, Germany, 13353|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|