Clinical trial NCT06445023: A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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-CSU1)
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: 2024-06-06
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 participants 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: Birmingham
country: United States
facility: Cahaba Dermatology Skin Health Center
state: Alabama
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center Scottsdale
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology - Fountain Valley
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research
state: California
city: Redwood City
country: United States
facility: Allergy and Asthma Consultants
state: California
city: San Diego
country: United States
facility: West Dermatology Research Center
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Upland
country: United States
facility: Integrated Research of Inland, Inc.
state: California
city: Wheat Ridge
country: United States
facility: Western States Clinical Research Inc
state: Colorado
city: Boynton Beach
country: United States
facility: Encore Medical Research Boynton Beach
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research Inc - Miami
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals, LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Clarksville
country: United States
facility: DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Allergy and Asthma Specialists PSC
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management LLC - Southshore Office
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
city: Rockville
country: United States
facility: DermAssociates, LLC
state: Maryland
city: Wheaton
country: United States
facility: Institute For Asthma and Allergy
state: Maryland
city: Ann Arbor
country: United States
facility: David Fivenson MD Dermatolgy PLLC
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Ypsilanti
country: United States
facility: Resp Medicine Research Institute of MI
state: Michigan
city: Lee's Summit
country: United States
facility: Dermatolgy and Skin Cancer Center
state: Missouri
city: Saint Joseph
country: United States
facility: MediSearch, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Ocean City
country: United States
facility: Allergy Partners of N.J., P.C.
state: New Jersey
city: Cortland
country: United States
facility: Smith Allergy & Asthma Specialists of Central New York
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Findlay
country: United States
facility: Auni Allergy
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Southern Plains Medical Center - Chickasha
state: Oklahoma
city: Clackamas
country: United States
facility: Portland Allergy and Asthma
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia, LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC - CRN - PPDS
state: South Carolina
city: Dallas
country: United States
facility: Alina Clinical Trials
state: Texas
city: Plano
country: United States
facility: VAST Clinical Research - Plano
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Care of Waco
state: Texas
city: Murray
country: United States
facility: University of Utah - MidValley Dermatology - PPDS
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Buenos Aires
country: Argentina
facility: Buenos Aires Skin
state: Buenos Aires Province
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Buenos Aires Province
city: Lobos
country: Argentina
facility: CEMLO:Centro de Especialidades Medicas Lobos
state: Buenos Aires Province
city: Buenos Aires
country: Argentina
facility: Hospital Italiano De Buenos Aires
state: Caba
city: Caba
country: Argentina
facility: Conexa Investigacion Clinica
state: Ciudad Autonoma de Buenos Aires
city: Caba
country: Argentina
facility: Aprillus Asistencia e Investigacion
state: Ciudad Autonoma de Buenos Aires
city: Caba
country: Argentina
facility: CARE- Centro de Alergia y Enfermedades Respiratorias
state: Ciudad Autonoma de Buenos Aires
city: Rosario
country: Argentina
facility: Centro Respiratorio Infantil
state: Sante Fe
city: Rosario
country: Argentina
facility: Instituto de Especialidades de Salud Rosario
state: Sante Fe
city: Rosario
country: Argentina
facility: Servicio de Investigacion de Patologias Alergicas
state: Sante Fe
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
state: Sante Fe
city: San Miguel de Tucuman
country: Argentina
facility: C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Instituto de Alergia e Inmunologia del Sur
city: Edegem
country: Belgium
facility: UZ Antwerp
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Saint Luc
city: Brussels
country: Belgium
facility: CHU de Liège
city: Gent
country: Belgium
facility: UZ Gent
city: Maldegem
country: Belgium
facility: Dermatologie Maldegem
city: Haskovo
country: Bulgaria
facility: "Medical center MedTech Services" OOD
city: Plovdiv
country: Bulgaria
facility: Diagnostic Consultative Center Pulmed
city: Razgrad
country: Bulgaria
facility: Aipsimpa D-R Talyat Sali Cholak Eood
city: Sofia
country: Bulgaria
facility: Medical Center Iskar EOOD
city: Sofia
country: Bulgaria
facility: MC Excelsior OOD
city: Sofia
country: Bulgaria
facility: DCC Fokus - 5 OOD LZIBP
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: UMHATEM " N.I.Pirogov"
city: Sofia
country: Bulgaria
facility: Medical Center Pulmovision
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Zara-Med" EOOD
city: Yambol
country: Bulgaria
facility: MBAL Sv. Panteleymon AD
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre - Probity - PPDS
state: Alberta
city: St. John's
country: Canada
facility: Skincare Research
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Triple A Lab
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Richmond Hill
country: Canada
facility: Centre for Dermatology and Cosmetic Surgery
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Centre - Probity - PPDS
state: Ontario
city: Toronto
country: Canada
facility: Evidence Based Medical Educator Inc.
state: Ontario
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika
city: Praha 1
country: Czechia
facility: Sanatorium profesora Arenbergera
city: Praha 6
country: Czechia
facility: Kožní ambulance Fialová, s.r.o.
city: Praha 8
country: Czechia
facility: Fakultní nemocnice Bulovka, Dermatovenerologická klinika
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon - Hôpital Lyon Sud
state: Rhone
city: La Tronche
country: France
facility: CHU de Grenoble Alpes - Hôpital Michallon
city: Nantes
country: France
facility: CHRU Nantes Hôtel Dieu
city: Nice
country: France
facility: CHU de Nice-Hôpital L'Archet
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Rouen
country: France
facility: CHRU Rouen - Hôpital Charles-Nicolle
city: Langenau
country: Germany
facility: Praxis Dr. Beate Schwarz
state: Baden-Württemberg
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
state: Hesse
city: Löhne
country: Germany
facility: Siteworks Prüfzentrum Lohne - PPDS
state: Niedersachsen
city: Bonn
country: Germany
facility: MVZ Dermatologisches Zentrum Bonn GmbH - Praxis Friedensplatz
state: Nordrhein-Westfalen
city: Dülmen
country: Germany
facility: ProDerma
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: UKSH Kiel
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Medizinisches Versorgungszentrum DermaKiel GmbH
state: Schleswig-Holstein
city: Bramsche
country: Germany
facility: Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR
city: Mainz
country: Germany
facility: Dermatologie Quist
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Athens
country: Greece
facility: Andreas Syggros Hospital
city: Attikí
country: Greece
facility: Attikon General University Hospital
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki 'Papageorgiou'
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche
city: Mantova
country: Italy
facility: ASST Carlo Poma
city: Milano
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma
city: Seongdong
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul Teugbyesolsi
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
city: Białystok
country: Poland
facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
city: Bydgoszcz
country: Poland
facility: Pratia Bydgoszcz
city: Elbląg
country: Poland
facility: Ambulatorium Sp. zo.o.
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o
city: Katowice
country: Poland
facility: "SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach
city: Katowice
country: Poland
facility: Centrum Medyczne Katowice - PRATIA - PPDS
city: Kielce
country: Poland
facility: Polimedica PTG Kielce
city: Kraków
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.
city: Poznan
country: Poland
facility: Pratia S.A. Centrum Medyczne Pratia Poznań
city: Poznań
country: Poland
facility: Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.
city: Skarzysko-Kamienna
country: Poland
facility: NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna
city: Szczecin
country: Poland
facility: Laser Clinic S.C
city: Toruń
country: Poland
facility: MICS Centrum Medyczne Torun
city: Warsaw
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
city: Wroclaw
country: Poland
facility: Przychodnia FutureMeds Wroclaw
city: Wrocław
country: Poland
facility: Ginemedica
city: Wrocław
country: Poland
facility: Diagnostic Consultative Center Pulmed
city: Wrocław
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
city: Łódź
country: Poland
facility: Santa Familia PTG Łódź
city: Aveiro
country: Portugal
facility: ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
city: Braga
country: Portugal
facility: Centro Clínico Académico, Braga - Hospital de Braga
city: Coimbra
country: Portugal
facility: ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Hospital Lusiadas Lisboa
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde de Santa Maria
city: Matosinhos
country: Portugal
facility: ULS de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: ULS de Santo António, EPE - Hospital de Santo António
city: Setúbal
country: Portugal
facility: ULS da Arrábida, EPE - Hospital de São Bernardo
city: Vila Nova De Gaia
country: Portugal
facility: Unidade Local de Saúde de Gaia/Espinho - Unidade I
city: Bloemfontein
country: South Africa
facility: Iatros International
state: Free State
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Newtown
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: About Allergy
state: Gauteng
city: Pretoria
country: South Africa
facility: Ryexo Clinical Research
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre
state: Gauteng
city: Durban
country: South Africa
facility: Synapta Clinical Research
state: Kwa-Zulu Natal
city: Mowbray
country: South Africa
facility: University of Cape Town Lung Institute
state: Western Cape
city: Pretoria
country: South Africa
facility: Global Clinical Trials
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Córdoba
country: Spain
facility: C.H. Regional Reina Sofia
city: Madrid
country: Spain
facility: Future Meds Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario De Salamanca
city: Villareal
country: Spain
facility: Hospital Universitario de la Plana
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital -PPDS
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei City
country: Taiwan
facility: MacKay Memorial Hospital -Taipei branch
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
References: