A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Biological: Matching placebo
- Registration Number
- NCT06455202
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
- Detailed Description
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.
There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 915
-
Males and females, >/= 18 years of age.
-
Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).
-
CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
- Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
- UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment.
-
Normal blood counts and liver function tests.
-
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
-
Willing and able to complete a daily symptom electronic diary and comply with study visits.
-
Participants with and without prior biologic experience are eligible.
Key
- Women who are pregnant or nursing.
- Chronic urticaria whose predominant manifestation is due to CIndU.
- Other diseases associated with urticaria.
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
- History of anaphylaxis
- Prior treatment with barzolvolimab
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description barzolvolimab 150 mg barzolvolimab barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks Placebo then barzolvolimab 150 mg Matching placebo Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks. Placebo then barzolvolimab 300 mg Matching placebo Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks. Placebo then barzolvolimab 300 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks. barzolvolimab 300 mg barzolvolimab barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks Placebo then barzolvolimab 150 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
- Primary Outcome Measures
Name Time Method Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) From Day 1 (first dose) to Day 85 (Week 12) Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
- Secondary Outcome Measures
Name Time Method Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12 From Day 1 (first dose) to Day 85 (Week 12) Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.
Mean change from baseline in UAS7 at Week 24 From Day 1 (first dose) to Day 169 (Week 24) Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.Mean change from baseline in UAS7 at Week 4 From Day 1 (first dose) to Day 29 (Week 4) Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.Percentage of participants with UAS7 = 0 at Week 24 From Day 1 (first dose) to Day 169 (Week 24) Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) From Day 1 (first dose) to Day 85 (Week 12) The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.
Percentage of patients with UAS7=0 at Week 12 From Day 1 (first dose) to Day 85 (Week 12) Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12 From Day 1 (first dose) to Day 85 (Week 12) Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.Percentage of participants with UAS7 ≤ 6 at Week 12 From Day 1 (first dose) to Day 85 (Week 12) Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7 \</=6) at Week 12.
Incidence of Treatment-Emergent Adverse Events From Day 1 (first dose) to Day 477 (Week 68) Occurrence of treatment emergent adverse events and serious adverse events during the study.
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) From Day 1 (first dose) to Day 85 (Week 12) The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.
Trial Locations
- Locations (148)
LEADER research
🇨🇦Hamilton, Ontario, Canada
Allervie Clinical Research - Cullman
🇺🇸Cullman, Alabama, United States
Research Solutions of Arizona PC
🇺🇸Litchfield Park, Arizona, United States
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
🇺🇸Scottsdale, Arizona, United States
Center for Dermatology & Plastic Surgery
🇺🇸Scottsdale, Arizona, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Kern Research, Inc.
🇺🇸Bakersfield, California, United States
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
LA Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
Allergy and Asthma Associates of Southern Cal
🇺🇸Mission Viejo, California, United States
WR-MCCR
🇺🇸San Diego, California, United States
University Clinical Trials
🇺🇸San Diego, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Raffi Tachdjian MD, Inc
🇺🇸Santa Monica, California, United States
Clarity Dermatology, PLLC
🇺🇸Castle Rock, Colorado, United States
Asthma and Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
ClearlyDerm Boca Raton - ClinEdge - PPDS
🇺🇸Boca Raton, Florida, United States
Driven Research LLC
🇺🇸Coral Gables, Florida, United States
Dolphin Medical Research
🇺🇸Doral, Florida, United States
Deluxe Health Center
🇺🇸Tampa, Florida, United States
Revival Clinical Research
🇺🇸Orlando, Florida, United States
Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
🇺🇸Tallahassee, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
🇺🇸Tampa, Florida, United States
Lane Dermatology Research - Centricity - PPDS
🇺🇸Columbus, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Henry J. Kanarek - Allergy,Asthma&Immunology
🇺🇸Overland Park, Kansas, United States
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
🇺🇸Baton Rouge, Louisiana, United States
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
🇺🇸Towson, Maryland, United States
Derm Institute of Western Michigan
🇺🇸Caledonia, Michigan, United States
Clarkston Skin Research - Clarkston
🇺🇸Clarkston, Michigan, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Midwest Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Skin Specialists PC
🇺🇸Omaha, Nebraska, United States
OptiSkin Medical
🇺🇸New York, New York, United States
Optimed Research Ltd - ClinEdge - PPDS
🇺🇸Columbus, Ohio, United States
Clinical Partners LLC
🇺🇸Johnston, Rhode Island, United States
University of Texas Health McGovern Medical
🇺🇸Bellaire, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Rainey & Finklea San Antonio Dermatology
🇺🇸San Antonio, Texas, United States
Allergy Associates of Utah - Sandy
🇺🇸Murray, Utah, United States
Jordan Valley Dermatology Center-South Jordan
🇺🇸South Jordan, Utah, United States
Kalo Clinical Research
🇺🇸West Valley City, Utah, United States
Virginia Dermatology and Skin Cancer Center - Norfolk
🇺🇸Norfolk, Virginia, United States
Skin and Cancer Foundation - The Skin Hospital
🇦🇺Darlinghurst, New South Wales, Australia
St George Dermatology and Skin Cancer Center
🇦🇺Kogarah, New South Wales, Australia
Novatrials
🇦🇺Kotara, New South Wales, Australia
Momentum Darlinghurst
🇦🇺Sydney, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Cornerstone Dermatology
🇦🇺Coorparoo, QSL, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
🇦🇺East Melbourne, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Medical Centre Asklepii OOD
🇧🇬Dupnitsa, Bulgaria
Medical Center - Pulmo 2018
🇧🇬Haskovo, Bulgaria
Medical Center Medconsult Pleven
🇧🇬Lovech, Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik AD
🇧🇬Pazardzhik, Bulgaria
Medical Center Prolet
🇧🇬Ruse, Bulgaria
Medical Center Unimed EOOD
🇧🇬Sevlievo, Bulgaria
Diagnostic-consultative center Ascendent EOOD
🇧🇬Sofia, Bulgaria
Diagnostic and Consultative Center Aleksandrovska EOOD
🇧🇬Sofia, Bulgaria
Diagnostic-Consultative Centre Convex EOOD
🇧🇬Sofia, Bulgaria
Vida Clinical Research
🇨🇦Edmonton, Alberta, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Ottawa Allergy Research Corporation
🇨🇦Ottawa, Ontario, Canada
York Dermatology Clinic & Research Centre
🇨🇦Richmond Hill, Ontario, Canada
North York Research Inc.
🇨🇦Toronto, Ontario, Canada
Joel Liem Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Saskatoon Dermatology Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Clinica MEDS La Dehesa
🇨🇱Lo Barnechea, Chile
Enroll SpA - Dr. Manuel Barros Borgono
🇨🇱Providencia, Chile
Centro Internacional de Estudios Clinicos (CIEC)
🇨🇱Recoleta, Chile
BIOCINETIC Ltda
🇨🇱Santiago, Chile
Dermacross Clinica Dermatologica
🇨🇱Vitacura, Chile
Centro de Inmunología y Genética - CIGE S.A.S
🇨🇴Medellin, Colombia
LTD" Healthy Future"
🇬🇪Tbilisi, Georgia
LTD "Center of Allergy and Immunology"
🇬🇪Tbilisi, Georgia
David Abuladze Georgian Italian Clinic
🇬🇪Tbilisi, Georgia
LTD "Multiprofile Clinic Consilium Medulla"
🇬🇪Tbilisi, Georgia
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Emovis GmbH
🇩🇪Berlin, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Eurofins bioskin Research Center Dermalology
🇩🇪Hamburg, Germany
UKSH Lübeck, Institut für Entzündungsmedizin
🇩🇪Lübeck, Germany
Hautarztpraxis Dariusch Mortazawi
🇩🇪Remscheid, Germany
Universitäts-Hautklinik, Studienzentrum Immundermatologie
🇩🇪Tübingen, Germany
Allergo-Derm Bakos Kft.
🇭🇺Szolnok, Hungary
Nirmal Hospital PVT LTD
🇮🇳Surat, Gujarat, India
Medical College Baroda & SSG Hospital
🇮🇳Vadodara, Gujarat, India
Shree Hospital & Critical Care Centre
🇮🇳Nagpur, Maharashtra, India
Assured Care Plus Hospital
🇮🇳Nashik, Maharashtra, India
Oyster & Pearl Hospitals
🇮🇳Pune, Maharashtra, India
Excelcare Hospital
🇮🇳Jaipur, Rajasthan, India
G.S.V.M. Medical College - Kanpur
🇮🇳Kanpur, Uttar Pradesh, India
B. J. Medical College and Civil Hospital
🇮🇳Ahmedabad, India
K R Hospital
🇮🇳Mysore, India
Asst Fbf Sacco
🇮🇹Milano, Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
CD8 Klinika
🇱🇹Kaunas, Lithuania
UAB Ausros Medicinos Centras
🇱🇹Kaunas, Lithuania
Santaros KTC (klinikiniu tyrimu centras)
🇱🇹Vilnius, Lithuania
Bravis Hospital
🇳🇱Roosendaal, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Klinika Dermatologii i Dermatologii Onkologicznej
🇵🇱Częstochowa, Poland
Centrum Medyczne Pratia Częstochowa
🇵🇱Częstochowa, Poland
Synexus Polska Sp. z o.o.
🇵🇱Warszawa, Poland
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
🇵🇱Grodzisk Mazowiecki, Poland
Centrum Medyczne "All-Med" Badania Kliniczne
🇵🇱Kraków, Poland
Velocity Nova Sp. z o.o.
🇵🇱Lublin, Poland
Pro Life Medica ETG Lublin
🇵🇱Lublin, Poland
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
🇵🇱Lublin, Poland
Medicome Sp. Z O.O.
🇵🇱Oświęcim, Poland
Centrum Alergologii Teresa Hofman Sp. z.o.o.
🇵🇱Poznań, Poland
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
🇵🇱Poznań, Poland
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
🇵🇱Rzeszów, Poland
EMED Centrum Usług Medycznych Ewa Śmiałek
🇵🇱Rzeszów, Poland
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
🇵🇱Tarnów, Poland
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
🇵🇱Warszawa, Poland
ETG Warszawa
🇵🇱Warszawa, Poland
Cliniq s.r.o.
🇸🇰Bratislava, Slovakia
Derma therapy spol. s.r.o.
🇸🇰Bratislava, Slovakia
ALERSA, sro
🇸🇰Košice, Slovakia
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitari Puerta del Mar
🇪🇸Cadiz, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Clinica Universidad Navarra- Madrid
🇪🇸Madrid, Spain
Hospital 12 De Octubre
🇪🇸Madrid, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain
Clinica Universidad Navarra- Pamplona
🇪🇸Pamplona, Spain
Complejo Hospitalario Universitario de Pontevedra- Centro Especialidades de Mollabao
🇪🇸Pontevedra, Spain
Hospital Quironsalud Madrid
🇪🇸Pozuelo De Alarcón, Spain
Hospital universitario Virgen Macarena
🇪🇸Sevilla, Spain
FutureMeds Sevilla
🇪🇸Sevilla, Spain
Hospital Universitario de Torrejón
🇪🇸Torrejón De Ardoz, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Hospital de Manises
🇪🇸Valencia, Spain
Siriraj Hospital
🇹🇭Bangkok Noi, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Thammasat University Hospital
🇹🇭Khlong Luang, Thailand
Khon Kaen University
🇹🇭Khon Kaen, Thailand
Cambridge University Hospitals, Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
Velocity Clinical Research, North London - PPDS
🇬🇧North Finchley, United Kingdom
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom