Clinical trial NCT06455202: A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Spontaneous Urticaria
Keywords: CDX-0159
barzolvolimab
chronic spontaneous urticaria
CSU
urticaria activity score
itch severity score
hives severity score
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

1. Males and females, \>/= 18 years of age.
2. Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

   1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
   3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.

Key Exclusion Criteria:

1. Women who are pregnant or nursing.
2. Chronic urticaria whose predominant manifestation is due to CIndU.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. 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.
8. History of anaphylaxis
9. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Primary outcomes:
measure: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcomes:
measure: Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Percentage of patients with UAS7=0 at Week 12
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Percentage of participants with UAS7 ≤ 6 at Week 12
timeFrame: From Day 1 (first dose) to Day 85 (Week 12)
measure: Mean change from baseline in UAS7 at Week 4
timeFrame: From Day 1 (first dose) to Day 29 (Week 4)
measure: Mean change from baseline in UAS7 at Week 24
timeFrame: From Day 1 (first dose) to Day 169 (Week 24)
measure: Percentage of participants with UAS7 = 0 at Week 24
timeFrame: From Day 1 (first dose) to Day 169 (Week 24)
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: From Day 1 (first dose) to Day 477 (Week 68)
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Allervie Clinical Research - Cullman
state: Alabama
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona PC
state: Arizona
city: Scottsdale
country: United States
facility: Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology & Plastic Surgery
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research, Inc.
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc.
state: California
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern Cal
state: California
city: San Diego
country: United States
facility: Apex Clinical Research
state: California
city: San Diego
country: United States
facility: WR-MCCR
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Santa Monica
country: United States
facility: Raffi Tachdjian MD, Inc
state: California
city: Castle Rock
country: United States
facility: Clarity Dermatology, PLLC
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates
state: Colorado
city: Boca Raton
country: United States
facility: ClearlyDerm Boca Raton - ClinEdge - PPDS
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Center
state: Florida
city: Orlando
country: United States
facility: Revival Clinical Research
state: Florida
city: Tallahassee
country: United States
facility: Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute (ACRI) - Florida
state: Florida
city: Tampa
country: United States
facility: Deluxe Health Center
state: Florida
city: Columbus
country: United States
facility: Lane Dermatology Research - Centricity - PPDS
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Henry J. Kanarek - Allergy,Asthma&Immunology
state: Kansas
city: Baton Rouge
country: United States
facility: Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Caledonia
country: United States
facility: Derm Institute of Western Michigan
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Skin Research - Clarkston
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Saint Louis
country: United States
facility: Midwest Clinical Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Riverdale
country: United States
facility: Impact Medical / Circuit Clinical
state: New Jersey
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Columbus
country: United States
facility: Optimed Research Ltd - ClinEdge - PPDS
state: Ohio
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Bellaire
country: United States
facility: University of Texas Health McGovern Medical
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Rainey & Finklea San Antonio Dermatology
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah - Sandy
state: Utah
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center-South Jordan
state: Utah
city: West Valley City
country: United States
facility: Kalo Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center - Norfolk
state: Virginia
city: Darlinghurst
country: Australia
facility: Skin and Cancer Foundation - The Skin Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Center
state: New South Wales
city: Kotara
country: Australia
facility: Novatrials
state: New South Wales
city: Sydney
country: Australia
facility: Momentum Clinical Research Darlinghurst
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Dupnitsa
country: Bulgaria
facility: Medical Centre Asklepii OOD
city: Haskovo
country: Bulgaria
facility: Medical Center - Pulmo 2018
city: Lovech
country: Bulgaria
facility: Medical Center Medconsult Pleven
city: Pazardzhik
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Pazardzhik AD
city: Ruse
country: Bulgaria
facility: Medical Center Prolet
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic-consultative center Ascendent EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic and Consultative Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Centre Convex EOOD
city: Edmonton
country: Canada
facility: Laser Rejuvenation Clinics Edmonton D.T. Inc.
state: Alberta
city: Edmonton
country: Canada
facility: Vida Clinical Research
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology Edmonton South
state: Alberta
city: Hamilton
country: Canada
facility: LEADER research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic & Research Centre
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: Joel Liem Medicine Professional Corporation
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Dermatology Centre
state: Saskatchewan
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis (Québec)
city: Lo Barnechea
country: Chile
facility: Clinica MEDS La Dehesa
city: Providencia
country: Chile
facility: Enroll SpA - Dr. Manuel Barros Borgono
city: Recoleta
country: Chile
facility: Centro Internacional de Estudios Clinicos (CIEC)
city: Santiago
country: Chile
facility: BIOCINETIC Ltda
city: Vitacura
country: Chile
facility: Dermacross Clinica Dermatologica
city: Medellin
country: Colombia
facility: Centro de Inmunología y Genética - CIGE S.A.S
city: Medellín
country: Colombia
facility: Fundación Centro de Investigation Clínica CIC
city: Soledad
country: Colombia
facility: Fundación Hospital Universidad del Norte
city: Tbilisi
country: Georgia
facility: LTD" Healthy Future"
city: Tbilisi
country: Georgia
facility: LTD "Center of Allergy and Immunology"
city: Tbilisi
country: Georgia
facility: David Abuladze Georgian Italian Clinic
city: Tbilisi
country: Georgia
facility: LTD "Multiprofile Clinic Consilium Medulla"
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen Hautklinik
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Emovis GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Eurofins bioskin Research Center Dermalology
city: Lübeck
country: Germany
facility: UKSH Lübeck, Institut für Entzündungsmedizin
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Remscheid
country: Germany
facility: Hautarztpraxis Dariusch Mortazawi
city: Tübingen
country: Germany
facility: Universitäts-Hautklinik, Studienzentrum Immundermatologie
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft.
city: Surat
country: India
facility: Nirmal Hospital PVT LTD
state: Gujarat
city: Vadodara
country: India
facility: Medical College Baroda & SSG Hospital
state: Gujarat
city: Nagpur
country: India
facility: Shree Hospital & Critical Care Centre
state: Maharashtra
city: Nashik
country: India
facility: Assured Care Plus Hospital
state: Maharashtra
city: Pune
country: India
facility: Oyster & Pearl Hospitals
state: Maharashtra
city: Jaipur
country: India
facility: Excelcare Hospital
state: Rajasthan
city: Kanpur
country: India
facility: G.S.V.M. Medical College - Kanpur
state: Uttar Pradesh
city: Ahmedabad
country: India
facility: B. J. Medical College and Civil Hospital
city: Belgaum
country: India
facility: KLES Dr Prabhakar Kore Hospital & Medical Research Centre
city: Mysore
country: India
facility: K R Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Vadodara
country: India
facility: Sumandeep Vidyapeeth University - Dhiraj Hospital
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Asst Fbf Sacco
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio e Ruggi d'Aragona
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Kaunas
country: Lithuania
facility: CD8 Klinika
city: Kaunas
country: Lithuania
facility: UAB Ausros Medicinos Centras
city: Vilnius
country: Lithuania
facility: UAB "Alerginių susirgimų diagnostikos ir gydymo centras"
city: Vilnius
country: Lithuania
facility: Santaros KTC (klinikiniu tyrimu centras)
city: Amsterdam
country: Netherlands
facility: AmdsterdamUMC locatie AMC
city: Roosendaal
country: Netherlands
facility: Bravis Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Częstochowa
country: Poland
facility: Klinika Dermatologii i Dermatologii Onkologicznej
city: Częstochowa
country: Poland
facility: Centrum Medyczne Pratia Częstochowa
city: Elbląg
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
city: Gdańsk
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
city: Kraków
country: Poland
facility: Centrum Medyczne "All-Med" Badania Kliniczne
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lublin
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Lublin
country: Poland
facility: Pro Life Medica ETG Lublin
city: Lublin
country: Poland
facility: LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
city: Oświęcim
country: Poland
facility: Medicome Sp. Z O.O.
city: Poznań
country: Poland
facility: Centrum Alergologii Teresa Hofman Sp. z.o.o.
city: Poznań
country: Poland
facility: EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
city: Poznań
country: Poland
facility: Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
city: Rzeszów
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
city: Rzeszów
country: Poland
facility: EMED Centrum Usług Medycznych Ewa Śmiałek
city: Tarnów
country: Poland
facility: ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
city: Warszawa
country: Poland
facility: Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Bardejov
country: Slovakia
facility: MAXDERM s.r.o.
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Bratislava
country: Slovakia
facility: Derma therapy spol. s.r.o.
city: Košice
country: Slovakia
facility: ALERSA, sro
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cadiz
country: Spain
facility: Hospital Universitari Puerta del Mar
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Clinica Universidad Navarra- Madrid
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra- Pamplona
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra- Centro Especialidades de Mollabao
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Quironsalud Madrid
city: Sevilla
country: Spain
facility: Hospital universitario Virgen Macarena
city: Sevilla
country: Spain
facility: FutureMeds Sevilla
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Valencia
country: Spain
facility: Hospital de Manises
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals, Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: North Finchley
country: United Kingdom
facility: Velocity Clinical Research, North London - PPDS
city: Oxford
country: United Kingdom
facility: Virtual Clinical Trials Centre, The Stables
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
References: