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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04833855
Other study ID # 20190194
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 15, 2021
Est. completion date April 13, 2023

Study information

Verified date March 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date April 13, 2023
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Signed informed consent must be obtained prior to participation in the study. - Male and female participants = 18 years and = 80 years of age at the time of screening. - Chronic spontaneous urticaria (CSU) diagnosis for = 6 months at the time of screening. - CSU inadequately controlled by second generation H1-antihistamines (sgAH) at enrollment, as defined by all of the following: - The presence of itch and hives for >= 6 consecutive weeks at any time prior to screening visit 2 - Failure to respond to an sgAH (up to 4 times the approved dose) - Urticaria Activity Score over 7 days (UAS7) (range 0-42) >= 16 and Hives Severity Score over 7 days (HSS7) (range 0-21) >= 8 during the 7 days prior to enrollment - Participant with CSU who discontinued, is intolerant to, or was an inadequate responder to anti-IgE therapies despite being treated with omalizumab 300 mg every 4 weeks (Q4W) for 6 months or higher doses of omalizumab > 2 months or another anti-IgE therapy. Note: This criterion is only applicable for anti-IgE-experienced participants. - Participant willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. - Subject must have been on a sgAH at approved or increased doses (up to 4x the approved dose) for treatment of CSU for at least 3 consecutive days immediately prior to the day -14 screening visit (screening visit 2) and must have documented current use on the day of screening visit 1 Exclusion Criteria: Disease related, including but not limited to: - Urticaria is solely due to inducible urticaria - Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals 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 active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, dermatitis herpetiformis, senile pruritus, etc.) - History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the participant in the study, interfere with evaluation of the investigational product, or reduce the participants ability to participate in the study. - Evidence of active tuberculosis (TB) (in the opinion of the investigator), either treated or untreated, or a positive purified protein derivative (PPD) or QuantiFERON-TB Gold Plus (QFT-Plus) test for TB during screening. - History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to screening visit 1. - Subject is unable to complete an electronic patient diary or complete questionnaires, or does not meet the required level of compliance with the eDiary during the 14 days sgAH stabilization period Other medical conditions - History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation. Prior/concomitant therapy, including but not limited to: - Treatment with any biologic products (eg, omalizumab, ligelizumab) within 4 months or 5 half-lives (whichever is longer) prior to screening visit 1 - Routine (daily or every other day for 5 or more consecutive days) use of systemic corticosteroids, systemic hydroxychloroquine, methotrexate, cyclosporine A, cyclophosphamide, tacrolimus, azathioprine, and mycophenolate mofetil within 30 days prior to screening visit 1. - Major surgery within 8 weeks prior to screening visit 1 or planned inpatient surgery or hospitalization during the study period. - Receipt of Ig or blood products within 30 days prior to screening visit 1. - Vaccination with a live or attenuated vaccine within 30 days prior to screening visit 1. Receipt of COVID-19 vaccines and inactive/killed vaccinations (eg, inactive influenza) are allowed, provided the vaccinations are not administered within 7 days before or after any study dosing visit. - Known hypersensitivity, including severe hypersensitivity reactions and/or history of anaphylactic shock, to any of the products or components to be administered during dosing or to products of similar chemical classes (ie, to murine, chimeric, or human antibodies.

Study Design


Intervention

Biological:
Tezepelumab Dose 1
Subcutaneous injection.
Tezepelumab Dose 2
Subcutaneous injection.
Omalizumab
Subcutaneous injection.
Placebo
Subcutaneous injection.

Locations

Country Name City State
Canada Dermatology Research Institute Incorporated Calgary Alberta
Canada Brunswick Dermatology Centre Fredericton New Brunswick
Canada LEADER Research Hamilton Ontario
Canada Lynderm Research Inc Markham Ontario
Canada Cheema Research Incorporated Mississauga Ontario
Canada Dr. S. K. Siddha Medicine Professional Corporation Newmarket Ontario
Canada Allergy Research Canada Incorporated Niagara Falls Ontario
Canada Gordon Sussman Clinical Research Incorporated North York Ontario
Canada Clinique Spécialisée en Allergie de la Capitale Quebec
France Centre Hospitalier Universitaire de Brest - Hôpital Morvan Brest
France Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Grenoble Cedex 9
France Hôpital Saint Eloi Montpellier cedex 5
France Centre Hospitalier Universitaire Archet 2 Nice
France Centre Hospitalier Lyon Sud Pierre Benite Cedex
Germany *Charité* Berlin
Germany Universitaetsklinikum Dresden Dresden
Germany Johannes Gutenberg Universitaet Mainz Mainz
Greece Andreas Syggros Hospital Athens
Greece Attikon University General Hospital of Athens Athens
Greece Laiko General Hospital of Athens Athens
Greece Sotiria General Hospital Athens
Greece George Papageorgiou General Hospital of Thessaloniki Thessaloniki
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano
Italy Azienda Ospedaliero Universitaria di Modena Modena
Italy Fondazione Policlinico Tor Vergata Roma
Italy Policlinico Universitario Agostino Gemelli Roma
Italy IRCCS Istituto Clinico Humanitas Rozzano MI
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino
Japan Osaka Habikino Medical Center Habikino-shi Osaka
Japan Hiroshima University Hospital Hiroshima-shi Hiroshima
Japan Nihon University Itabashi Hospital Itabashi-ku Tokyo
Japan Kosugi Dermatology Clinic Kawasaki-shi Kanagawa
Japan Fujita Health University Bantane Hospital Nagoya-shi Aichi
Japan Takagi Dermatological Clinic Obihiro-shi Hokkaido
Japan Dermatology and Ophthalmology Kume Clinic Sakai-shi Osaka
Japan NTT Medical Center Tokyo Shinagawa-ku Tokyo
Japan Nomura Dermatology Clinic Yokohama-shi Kanagawa
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Hwaseong-si, Gyeonggi-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Ajou University Hospital Suwon-si, Gyeonggi-do
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa Lodz
Poland SPZOZ Centralny Szpital Kliniczny Lodz
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin
Poland Clinical Research Center Spzoo Medic-R Spolka Komandytowa Poznan
Poland Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina Rzeszow
Poland Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski Warszawa
Poland Wojskowy Instytut Medyczny Warszawa
Spain Hospital de la Santa Creu i Sant Pau Barcelona Cataluña
Spain Hospital del Mar Barcelona Cataluña
Spain Hospital Universitari de Bellvitge Hospitalet de LLobregat Cataluña
Spain Hospital Arnau de Vilanova de Valencia Valencia Comunidad Valenciana
Spain Hospital General Universitario de Valencia Valencia Comunidad Valenciana
United States David Fivenson MD Professional Liability Company Ann Arbor Michigan
United States Johns Hopkins Asthma and Allergy Center Baltimore Maryland
United States Clinical Research Center of Alabama Birmingham Alabama
United States Bernstein Clinical Research Center LLC Cincinnati Ohio
United States Clarkston Skin Research Clarkston Michigan
United States Asthma and Allergy Associates PC Colorado Springs Colorado
United States Henry Ford Medical Center - New Center One Detroit Michigan
United States Aventiv Research Inc Dublin Ohio
United States First OC Dermatology Fountain Valley California
United States Suzanne Bruce and Associates Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Clinical Partners LLC Johnston Rhode Island
United States The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research Knoxville Tennessee
United States Avance Clinical Trials Laguna Niguel California
United States Cutis Wellness Dermatology and Dermatopathology, PLLC Laredo Texas
United States Bluegrass Allergy Care Lexington Kentucky
United States Dermatology Research Associates Los Angeles California
United States Jonathan Corren MD Inc Los Angeles California
United States Family Allergy and Asthma Research Institute Louisville Kentucky
United States The Community Research of South Florida Miami Lakes Florida
United States Icahn School of Medicine at Mount Sinai New York New York
United States Epiphany Dermatology of Kansas, LLC Overland Park Kansas
United States Washington University School of Medicine Saint Louis Missouri
United States Advanced Medical Research PC Sandy Springs Georgia
United States Clinical Science Institute Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 16 The UAS is a CSU-specific patient-reported outcome measure with 2 components: Hives Severity Score (HSS) for number of wheals and an Itch Severity Score (ISS) for itch intensity, and are each scored from 0 (no wheals, no itch) to 3 (>50 wheals, severe itch) for the previous 24 hours. The HSS and ISS are combined to give a daily UAS ranging from 0 to 6. The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). The least squares mean (LSM) estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity. Baseline and Week 16
Secondary Change From Baseline in ISS Over 7 Days (ISS7) at Week 16 The ISS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed itch intensity, with daily scores ranging from 0 (no itch) to 3 (severe itch) for the previous 24 hours. The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline ISS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity. Baseline and Week 16
Secondary Change From Baseline in HSS Over 7 Days (HSS7) at Week 16 The HSS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed the number of wheals, with daily scores ranging from 0 (no wheals) to 3 (>50 wheals) for the previous 24 hours. The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline HSS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity. Baseline and Week 16
Secondary Number of Participants With a UAS7 of = 6 (Minimal Residual Disease) at Week 16 The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal residual disease in UAS7 was defined as a score = 6 and indicates well-controlled urticaria and a good response to treatment. Week 16
Secondary Number of Participants With a Change From Baseline in UAS7 of = -10 (Minimal Important Difference) The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal important difference in UAS7 was defined as a change from baseline of = -10. Baseline and Week 16
Secondary Number of Participants With a UAS7 = 0 at Week 16 (Complete Response) The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). A complete response was defined as UAS7 = 0 at Week 16. Week 16
Secondary Number of Participants With ISS7 = 0 at Week 16 (Complete Resolution) The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). An ISS7 = 0 indicates a complete resolution of itch. Week 16
Secondary Number of Participants With a Change From Baseline in ISS7 of = -5 (Minimal Important Difference) The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). Minimal important difference in ISS7 was defined as a change from baseline of = -5. Baseline and Week 16
Secondary Number of Participants With HSS7 = 0 at Week 16 (Complete Resolution) The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). An HSS7 = 0 indicates a complete resolution of hives. Week 16
Secondary Number of Participants With a Change From Baseline in HSS7 of = -5.5 (Minimal Important Difference) The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). Minimal important difference in HSS7 was defined as a change from baseline of = -5.5. Baseline and Week 16
Secondary Change From Baseline in Weekly Sleep Interference Score (SIS7) at Week 16 The SIS is part of the Urticaria Patient Daily Diary and was assessed by the participant using the electronic diary once daily in the morning. Participants scored sleep interference on a scale of 0 (no interference) to 3 (substantial, woke up often, severe interference with sleep). The SIS7 was a sum of the daily scores over 7 days ranging from 0 to 21. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SIS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep interference. Baseline and Week 16
Secondary Change From Baseline in Weekly Sleep Quality Score (SQS7): Sum of Daily SQS at Week 16 The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of the 3 daily sleep quality items over 7 days, ranged from 0 (good quality sleep) to 63 (poor quality sleep). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of SQS, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality. Baseline and Week 16
Secondary Change From Baseline in SQS7: Sum of Average Daily Q1 - Q3 at Week 16 The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of average daily Q1 - Q3 score was generated by averaging 3 daily sleep quality items and then summing the daily average over 7 days with a score ranging from 0 (good quality sleep) to 21 (poor quality sleep) (sum of the average daily Q1 - Q3). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of average daily Q1 - Q3, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality. Baseline and Week 16
Secondary Change From Baseline in Urticaria Control Test (UCT) Score at Week 16 The UCT assesses disease control in participants with CSU through a retrospective validated scoring system, evaluating the physical symptoms of chronic urticaria (itch, hives and/or angioedema) and the effectiveness of treatment over 4 weeks. It consists of 4 questions with 5 answer options, scored from 0 to 4, and the UCT score is the sum of all 4 questions, with total score ranging from 0 (no control) to 16 (complete control). A score of = 12 indicates well-controlled urticaria and a score of = 11 points indicates poor disease control. A positive change from baseline indicates an improvement in disease control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UCT score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Change From Baseline in Weekly Angioedema Activity Score (AAS7) at Week 16 The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Negative changes from baseline indicate an improvement in angioedema activity. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AAS7, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Number of Cumulative Weeks That Participants Achieved AAS7 = 0 at Week 16 (Angioedema Occurrence Free) The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Angioedema occurrence free was defined as AAS7 = 0. Baseline to Week 16
Secondary Change From Baseline in the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Week 16 The CU-Q2oL is a 23-item, self-reported urticaria-specific measure to evaluate 6 dimensions of quality of life (QoL): pruritus, impact on life activities, sleep problems, limitations, looks, and swelling. The total score is transformed to a linear scale of 0 to 100 with a higher CU-Q2oL score indicating a higher QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline CU-Q2oL score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 16 The DLQI is a 10-item, participant-completed, health-related QoL assessment with content specific to those with dermatology conditions. The DLQI evaluates participant perceptions including dermatology-related symptoms and feelings, impacts on daily activities, leisure, work or school, personal relationships, and side effects of treatment. The recall period was 1 week. The DLQI total score ranges from 0 to 30 with a higher score indicating a greater QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline DLQI score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Change From Baseline in the Angioedema Quality of Life Questionnaire (AE-QoL) at Week 16 The AE-QoL is a validated angioedema QoL questionnaire for participants with angioedema. It consists of 17 questions evaluating 4 domains including functioning, fatigue/mood, fear/shame, and food with a recall period of 4 weeks. The total score is transformed to a linear scale ranging from 0 to 100, with a higher score indicating a worse impairment in QoL. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AE-QoL score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Change From Baseline in the Angioedema Control Test (AECT) Score at Week 16 The AECT is a patient-reported outcome measure to evaluate disease control in the domains of signs and symptoms, QoL, anxiety/fear, and effectiveness of therapy. The total AECT score ranges from 0 to 16, with higher scores indicating well-controlled disease. A positive change from baseline indicates an improvement in angioedema control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AECT score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Number of Participants With an AECT Score = 16 at Week 16 (Complete Control) The total AECT score ranges from 0 to 16, with higher scores indicating better controlled disease. Complete control was defined as AECT score = 16. Baseline and Week 16
Secondary Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16 The WPAI-CU is a questionnaire that assesses the impact of an intervention on work productivity, evaluating 4 areas including absenteeism, presenteeism, work productivity loss, and activity impairment over the past 7 days. Each of the areas is scored separately as a percentage, ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. A negative change from baseline indicates an improvement. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline WPAI-CU score, treatment, study week and the interaction between treatment and study week. Baseline and Week 16
Secondary Number of Cumulative Days of sgAH Rescue Medication Use From Baseline to Week 16 Participants recorded any need of sgAH rescue medication in their daily electronic diary. Baseline to Week 16
Secondary Serum Concentration of Tezepelumab The lower limit of quantification was 10 ng/mL, and values below this limit were set to zero. Week 1 pre-dose, Weeks 2, 4, 8, 12, 16, 24, and 32
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. TEAEs were AEs that started on or after the first dose of investigational product up to the end of study (Week 32). A serious AE (SAE) was defined as any untoward medical occurrence that met at least 1 of the following serious criteria: immediately life-threatening, required hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. Day 1 Week 1 to Week 32, up to 32 weeks
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