A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
EMBARQ-CSU1
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)
2 other identifiers
interventional
963
21 countries
235
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedStudy Start
First participant enrolled
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
March 25, 2026
March 1, 2026
2.2 years
May 31, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
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.
From Day 1 (first dose) to Day 85 (Week 12)
Secondary Outcomes (8)
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
From Day 1 (first dose) to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with UAS7 = 0 at Week 12
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with UAS7 ≤ 6 at Week 12
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12
From Day 1 (first dose) to Day 85 (Week 12)
- +3 more secondary outcomes
Study Arms (4)
barzolvolimab 150 mg
EXPERIMENTALbarzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
barzolvolimab 300 mg
EXPERIMENTALbarzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Placebo then barzolvolimab 150 mg
EXPERIMENTALPlacebo 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
EXPERIMENTALPlacebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
Interventions
Subcutaneous Administration
Matching placebo Subcutaneous Administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (235)
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244, United States
First OC Dermatology - Fountain Valley
Fountain Valley, California, 92708, United States
310 Clinical Research
Inglewood, California, 90301, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Focus Clinical Research - Los Angeles
Los Angeles, California, 91307, United States
Cura Clinical Research
Oxnard, California, 93030, United States
Allergy and Asthma Consultants
Redwood City, California, 94063, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
West Dermatology Research Center
San Diego, California, 92121, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Orso Health, Inc.
Torrance, California, 90505, United States
Integrated Research of Inland, Inc.
Upland, California, 91786, United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, 80033, United States
Encore Medical Research Boynton Beach
Boynton Beach, Florida, 33436, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
GSI Clinical Research
Margate, Florida, 33063, United States
International Dermatology Research Inc - Miami
Miami, Florida, 33144, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
GCP Global Clinical Professionals, LLC
St. Petersburg, Florida, 33705, United States
Paradigm Clinical Research Boise
Boise, Idaho, 83709, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis, Indiana, 46250, United States
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241, United States
Allergy and Asthma Specialists PSC
Owensboro, Kentucky, 42301, United States
Clinical Trials Management LLC - Southshore Office
Metairie, Louisiana, 70006, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
DermAssociates, LLC
Rockville, Maryland, 20850, United States
Institute For Asthma and Allergy
Wheaton, Maryland, 20902, United States
David Fivenson MD Dermatolgy PLLC
Ann Arbor, Michigan, 48103, United States
Resp Medicine Research Institute of MI
Ypsilanti, Michigan, 48197, United States
Dermatolgy and Skin Cancer Center
Lee's Summit, Missouri, 64064, United States
MediSearch, LLC
Saint Joseph, Missouri, 64506, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Excel Clinical Research - Las Vegas
Las Vegas, Nevada, 90301, United States
Allergy Partners of N.J., P.C.
Ocean City, New Jersey, 07712, United States
Finger Lakes Medical Research, PLLC
Cortland, New York, 13045, United States
Sadick Research Group
New York, New York, 10075, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Apex Clinical Research
Canton, Ohio, 44718, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Auni Allergy
Findlay, Ohio, 45840, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Toledo Institute of Clinical Research
Toledo, Ohio, 43617, United States
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Portland Allergy and Asthma
Clackamas, Oregon, 97015, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, 18114, United States
National Allergy and Asthma Research, LLC - CRN - PPDS
North Charleston, South Carolina, 29420, United States
Alina Clinical Trials
Dallas, Texas, 75225, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
VAST Clinical Research - Plano
Plano, Texas, 75033, United States
STAAMP Research, LLC - CRN
San Antonio, Texas, 78229, United States
Allergy and Asthma Care of Waco
Waco, Texas, 76712, United States
University of Utah - MidValley Dermatology - PPDS
Murray, Utah, 84107, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Buenos Aires Skin
Buenos Aires, Buenos Aires, C1054, Argentina
Fundacion Cidea
Buenos Aires, Buenos Aires, C1121ABE, Argentina
CEMLO:Centro de Especialidades Medicas Lobos
Lobos, Buenos Aires, 7240, Argentina
Hospital Italiano De Buenos Aires
Buenos Aires, Buenos Aires F.D., 1199, Argentina
Conexa Investigacion Clinica
CABA, Buenos Aires F.D., 1012, Argentina
Aprillus Asistencia e Investigacion
CABA, Buenos Aires F.D., 1406, Argentina
CARE- Centro de Alergia y Enfermedades Respiratorias
CABA, Buenos Aires F.D., C14141AIF, Argentina
Centro Respiratorio Infantil
Rosario, Sante Fe, 2000, Argentina
Instituto de Especialidades de Salud Rosario
Rosario, Sante Fe, 2000, Argentina
Servicio de Investigacion de Patologias Alergicas
Rosario, Sante Fe, 2000, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Sante Fe, S2000DEJ, Argentina
C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Clinica Mayo
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Centro Médico Vitae
Buenos Aires, Argentina
Instituto de Alergia e Inmunologia del Sur
Buenos Aires, Argentina
UZ Antwerp
Edegem, Antwerpen, 2650, Belgium
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
UZ Brussel
Brussels, 1090, Belgium
Saint Luc
Brussels, 1200, Belgium
CHU de Liège
Brussels, Belgium
Hôpital Erasme - Erasme Medical Center - PPDS
Brussels, Belgium
UZ Gent
Ghent, 9000, Belgium
Dermatologie Maldegem
Maldegem, 9990, Belgium
AlergoAlpha Allergia e Immunologia
Barueri, Brazil
Instituto de Pesquisas Clínicas LTDA Brasilia
Brasília, Brazil
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
Caxias do Sul, Brazil
Centro Paraibano de Pesquisas e Estudos Clínicos
João Pessoa, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Brazil
Hospital Universitário Clementino Fraga Filho (UFRJ)
Rio de Janeiro, Brazil
Clinica IBIS
Salvador, Brazil
Centro de Estudos de Pneumologia da Faculdade de Medecina do ABC
Santo André, Brazil
Centro de Pesquisa SVRI Hospital e Maternidade Christóvão da Gama
Santo André, Brazil
Clínica de Alergia Martti Antila
São Paulo, Brazil
Vidamed Care Clínica E Residência
Vitória, Brazil
"Medical center MedTech Services" OOD
Haskovo, 6304, Bulgaria
Diagnostic Consultative Center Pulmed
Plovdiv, Bulgaria
Aipsimpa D-R Talyat Sali Cholak Eood
Razgrad, 7200, Bulgaria
Medical Center Iskar EOOD
Sofia, 1000, Bulgaria
MC Excelsior OOD
Sofia, 1407, Bulgaria
DCC Fokus - 5 OOD LZIBP
Sofia, 1463, Bulgaria
Medical Center Hera EOOD
Sofia, 1510, Bulgaria
UMHATEM " N.I.Pirogov"
Sofia, 1606, Bulgaria
Medical Center Pulmovision
Sofia, 1756, Bulgaria
MBAL Sv. Panteleymon AD
Yambol, 8600, Bulgaria
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, Canada
Skincare Research
St. John's, Newfoundland and Labrador, Canada
Triple A Lab
Hamilton, Ontario, L8S1G5, Canada
Lynderm Research Inc
Markham, Ontario, L3P 1X3, Canada
Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5, Canada
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, M3B 0A7, Canada
Evidence Based Medical Educator Inc.
Toronto, Ontario, M5G1E2, Canada
Rejuvenation Dermatology and Aesthetics
Calgary, Canada
Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika
Prague, 10034, Czechia
Sanatorium profesora Arenbergera
Prague, 110 00, Czechia
Kožní ambulance Fialová, s.r.o.
Prague, 160 00, Czechia
Fakultní nemocnice Bulovka, Dermatovenerologická klinika
Prague, 18081, Czechia
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Bispebjerg Hospital
Copenhagen NV, 2400, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, Rhone, 69310, France
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, France
Cabinet du Dr Ruer-Mulard Mireille
Martigues, France
CHRU Nantes Hôtel Dieu
Nantes, 44093, France
CHU de Nice-Hôpital L'Archet
Nice, 06202, France
Hôpital La Pitié Salpêtrière
Paris, 75013, France
CHRU Rouen - Hôpital Charles-Nicolle
Rouen, France
Praxis Dr. Beate Schwarz
Langenau, Baden-Wurttemberg, 89129, Germany
Rosenpark Research GmbH
Darmstadt, Hesse, 64283, Germany
Siteworks Prüfzentrum Lohne - PPDS
Löhne, Lower Saxony, 49393, Germany
ProDerma
Dülmen, North Rhine-Westphalia, 48249, Germany
UKSH Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, Schleswig-Holstein, 24148, Germany
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin
Berlin, Germany
Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR
Bramsche, 49565, Germany
Dermatologie Quist
Mainz, 55128, Germany
LMU Klinikum der Universität München
München, Germany
Naval Hospital of Athens
Athens, 11521, Greece
Andreas Syggros Hospital
Athens, 16121, Greece
Attikon General University Hospital
Attiki, 12462, Greece
General Hospital of Thessaloniki 'Papageorgiou'
Thessaloniki, 56403, Greece
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60128, Italy
ASST Carlo Poma
Mantova, 46100, Italy
Istituti Clinici Scientifici Maugeri IRCCS
Milan, 20138, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 20128, Italy
Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma
Verona, 37134, Italy
Hospital Pulau Pinang
George Town, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Clinica Internacional - Sede Lima
Lima, Peru
Clinica Ricardo Palma
Lima, Peru
Clinica San Felipe
Lima, Peru
Medic Ser S.A.C. Auna Clinica Delgado
Lima, Peru
NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
Bialystok, 15-453, Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
Bialystok, Poland
Pratia Bydgoszcz
Bydgoszcz, 85-796, Poland
Ambulatorium Sp. zo.o.
Elblag, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o
Gdansk, 80-546, Poland
"SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach
Katowice, 40-040, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, 40-081, Poland
Polimedica PTG Kielce
Kielce, 25-355, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.
Krakow, 31-011, Poland
Santa Familia PTG Łódź
Lodz, 90-302, Poland
Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwesytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi
Lodz, Poland
Pratia S.A. Centrum Medyczne Pratia Poznań
Poznan, 60-185, Poland
Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.
Poznan, Poland
Synexus Polska Sp. z o.o. - Poznaniu
Poznan, Poland
NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna
Skarżysko-Kamienna, 26-110, Poland
Laser Clinic S.C
Szczecin, 70-332, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Klinika Ambroziak Dermatologia
Warsaw, 02-953, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02-962, Poland
FutureMeds - Targowek - PPDS
Warsaw, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, Poland
Ginemedica
Wroclaw, 50-414, Poland
Diagnostic Consultative Center Pulmed
Wroclaw, 50-566, Poland
Przychodnia FutureMeds Wroclaw
Wroclaw, 53-673, Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw, 54-144, Poland
Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.
Zabrze, Poland
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3004-561, Portugal
Hospital Lusiadas Lisboa
Lisbon, 1500-458, Portugal
Unidade Local de Saúde de Santa Maria
Lisbon, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, Portugal
ULS de Santo António, EPE - Hospital de Santo António
Porto, 4050-342, Portugal
ULS da Arrábida, EPE - Hospital de São Bernardo
Setúbal, 2910-548, Portugal
Unidade Local de Saúde de Gaia/Espinho - Unidade I
Vila Nova de Gaia, Portugal
Iatros International
Bloemfontein, Free State, 9301, South Africa
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FCRN Clinical Trial Centre
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Mowbray, Western Cape, 7700, South Africa
Infinity Dermatology Inc
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Sandton Medical Research Centre
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Hanyang University Seoul Hospital
Seongdong, Seoul Teugbyesolsi, 40763, South Korea
Korea University Ansan Hospital
Ansan, 15355, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 8208, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
C.H. Regional Reina Sofia
Córdoba, 14004, Spain
Future Meds Madrid
Madrid, 28002, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Complejo Asistencial Universitario De Salamanca
Salamanca, 37007, Spain
Hospital Universitario de la Plana
Villarreal de Huerva, 12540, Spain
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 300, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital -PPDS
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MacKay Memorial Hospital -Taipei branch
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
Ankara, Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi
Ankara, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Fatih, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, Turkey (Türkiye)
Erciyes University School of Medicine
Melikgazi, Turkey (Türkiye)
Ondokuz Mayis University Hospital
Samsun, Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Hastanesi
Trabzon, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 6, 2024
Study Start
July 11, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03