A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
EMBARQ-CSU2
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)
2 other identifiers
interventional
976
22 countries
245
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
245 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
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
July 19, 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
June 7, 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 patients 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 (245)
Allervie Clinical Research - Cullman
Cullman, Alabama, 35058, United States
Research Solutions of Arizona PC
Litchfield Park, Arizona, 85340, United States
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale, Arizona, 85258, United States
Center for Dermatology & Plastic Surgery
Scottsdale, Arizona, 85260, United States
Kern Research, Inc.
Bakersfield, California, 93301, United States
UCLA Clinical Trials Contracts & Strategic Relations
Los Angeles, California, 90024, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
LA Universal Research Center, Inc.
Los Angeles, California, 90057, United States
Allergy and Asthma Associates of Southern Cal
Mission Viejo, California, 92691, United States
Huntington Asthma & Allergy Center
Pasadena, California, 91107, United States
Apex Clinical Research
San Diego, California, 92120, United States
WR-MCCR
San Diego, California, 92120, United States
University Clinical Trials
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, 90404, United States
Clarity Dermatology, PLLC
Castle Rock, Colorado, 80109, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907, United States
Driven Research LLC
Coral Gables, Florida, 33134, United States
Palm Beach Dermatology Group
Delray Beach, Florida, 33484, United States
Dolphin Medical Research
Doral, Florida, 33172, United States
South FL Clinical Research LLC
Miami, Florida, 33165, United States
Dade Florida Clinical Research Center
Miami, Florida, 33173, United States
Deluxe Health Center
Miami Lakes, Florida, 33014, United States
Revival Clinical Research
Orlando, Florida, 32807, United States
International Clinical Research - FL LLC
Sanford, Florida, 32771, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, 33321, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, 33607, United States
Deluxe Health Center
Tampa, Florida, 33607, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33613, United States
Olympian Clinical Research
Tampa, Florida, 33615, United States
Lane Dermatology Research - Centricity - PPDS
Columbus, Georgia, 31904, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, 61761, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-8500, United States
Equity Medical
Bowling Green, Kentucky, 42104, United States
Allergy & Asthma Associates
Lexington, Kentucky, 40509, United States
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge, Louisiana, 70808, United States
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson, Maryland, 21204, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Derm Institute of Western Michigan
Caledonia, Michigan, 49316, United States
Clarkston Skin Research - Clarkston
Clarkston, Michigan, 48346, United States
Midwest Clinical Research, LLC
St Louis, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63141, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Hudson-Essex Allergy
Belleville, New Jersey, 07109, United States
Impact Medical / Circuit Clinical
Paramus, New Jersey, 07652, United States
Impact Medical / Circuit Clinical
Riverdale, New Jersey, 07457, United States
Equity Medical LLC
New York, New York, 10023, United States
OptiSkin Medical
New York, New York, 10128, United States
Optima Research
Boardman, Ohio, 44512, United States
Optimed Research Ltd - ClinEdge - PPDS
Columbus, Ohio, 43235, United States
Penn State Health Milton Hershey Med Cen
Hershey, Pennsylvania, 17033, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Western Sky Medical Research
El Paso, Texas, 79932, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Rainey & Finklea San Antonio Dermatology
San Antonio, Texas, 78213, United States
Allergy Associates of Utah - Sandy
Murray, Utah, 84107, United States
Kalo Clinical Research
West Valley City, Utah, 84120, United States
Novatrials
Charlestown, New South Wales, 2290, Australia
Skin and Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, 2010, Australia
St George Dermatology and Skin Cancer Center
Kogarah, New South Wales, 2217, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Cornerstone Dermatology
Coorparoo, Queensland, 4151, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Medical Centre Asklepii OOD
Dupnitsa, 2600, Bulgaria
Medical Center - Pulmo 2018
Haskovo, 6300, Bulgaria
Medical Center Medconsult Pleven
Lovech, 5500, Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik AD
Pazardzhik, 4400, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002, Bulgaria
Medical Center Prolet
Rousse, 7000, Bulgaria
Medical Center Unimed EOOD
Sevlievo, 5400, Bulgaria
Diagnostic-consultative center Ascendent EOOD
Sofia, 1202, Bulgaria
Diagnostic and Consultative Center Aleksandrovska EOOD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"
Sofia, 1527, Bulgaria
Diagnostic-Consultative Centre Convex EOOD
Sofia, 1680, Bulgaria
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9, Canada
Vida Clinical Research
Edmonton, Alberta, T6H 4J8, Canada
Rejuvenation Dermatology Edmonton South
Edmonton, Alberta, T6W 0J5, Canada
LEADER research
Hamilton, Ontario, L8L 3C3, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H1E4, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1, Canada
North York Research Inc.
Toronto, Ontario, M2N 3A6, Canada
Joel Liem Medicine Professional Corporation
Windsor, Ontario, N8X 2G1, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T0G3, Canada
Kingston Health Science Center
Kingston, K7L 2V7, Canada
Centre de Recherche Saint-Louis (Québec)
Québec, G1W4R4, Canada
Clinica MEDS La Dehesa
Lo Barnechea, 7691236, Chile
Hospital Base San Jose de Osorno
Osorno, 5290000, Chile
Enroll SpA - Dr. Manuel Barros Borgono
Providencia, 7500000, Chile
Clinica Davila - Recoleta
Recoleta, 8420000, Chile
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta, 8420383, Chile
BIOCINETIC Ltda
Santiago, 8350595, Chile
Medical Skin Center
Viña del Mar, 2520000, Chile
Dermacross Clinica Dermatologica
Vitacura, 7630000, Chile
Centro Integral de Reumatologia Del Caribe
Barranquilla, 8001, Colombia
Hospital Alma Mater de Antioquia
Medellín, 50010, Colombia
Centro de Inmunología y Genética - CIGE S.A.S
Medellín, 50012, Colombia
Hospital General de Medellín Luz Castro de Gutiérrez
Medellín, 50015, Colombia
Fundación Centro de Investigation Clínica CIC
Medellín, 50021, Colombia
Fundación Hospital Universidad del Norte
Soledad, 83001, Colombia
Special Hospital Medico
Rijeka, 51000, Croatia
Solmed Clinic
Zagreb, 10000, Croatia
LTD" Healthy Future"
Tbilisi, 0119, Georgia
LTD "Center of Allergy and Immunology"
Tbilisi, 0159, Georgia
David Abuladze Georgian Italian Clinic
Tbilisi, 0179, Georgia
LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi, 0186, Georgia
Universitätsklinikum der RWTH Aachen Hautklinik
Aachen, 52074, Germany
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Emovis GmbH
Berlin, 10629, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Eurofins bioskin Research Center Dermalology
Hamburg, 20095, Germany
UKSH Lübeck, Institut für Entzündungsmedizin
Lübeck, 23538, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Hautarztpraxis Dariusch Mortazawi
Remscheid, 42897, Germany
Universitäts-Hautklinik, Studienzentrum Immundermatologie
Tübingen, 72076, Germany
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, 4032, Hungary
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Allergo-Derm Bakos Kft.
Szolnok, 5000, Hungary
Nirmal Hospital PVT LTD
Surat, Gujarat, 395002, India
Medical College Baroda & SSG Hospital
Vadodara, Gujarat, 390001, India
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, 440009, India
Assured Care Plus Hospital
Nashik, Maharashtra, 422101, India
Oyster & Pearl Hospitals
Pune, Maharashtra, 411005, India
Excelcare Hospital
Jaipur, Rajasthan, 302012, India
G.S.V.M. Medical College - Kanpur
Kanpur, Uttar Pradesh, 208002, India
Panchshil Hospital - Ahmedabad
Ahmedabad, 380005, India
B. J. Medical College and Civil Hospital
Ahmedabad, 380016, India
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi, 590010, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Apex Hospitals Pvt Ltd
Jaipur, 302017, India
K R Hospital
Mysore, 570001, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Sumandeep Vidyapeeth University - Dhiraj Hospital
Vadodara, 391760, India
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Asst Fbf Sacco
Milan, 20157, Italy
Azienda Ospedale Università di Padova
Padua, 38068, Italy
Humanitas Research Hospital
Rozzano, 20089, Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
Ospedale San Lazzaro PO Molinette
Torino, 10126, Italy
CD8 Klinika
Kaunas, LT-44192, Lithuania
UAB Ausros Medicinos Centras
Kaunas, LT-49387, Lithuania
UAB "Alerginių susirgimų diagnostikos ir gydymo centras"
Vilnius, LT-08109, Lithuania
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, LT-08406, Lithuania
Unidad de Investigación Cima S.a
Chihuahua City, 31200, Mexico
Meidadvance Clinical
Chihuahua City, 31203, Mexico
Cryptex
Cuauhtémoc, 06100, Mexico
Centro de Investigación Medico Biologica
Guadalajara, 44130, Mexico
CIMET
Guadalajara, 44340, Mexico
Panamerican Guadalajara
Guadalajara, 44670, Mexico
Centro de Desarrollo Biomédico
Mérida, 97000, Mexico
Mérida Investigación Clínica
Mérida, 97125, Mexico
Eukarya Pharmasite
Monterrey, 64718, Mexico
CECYPE
Morelia, 58249, Mexico
Unidad de Medicina Especializada
San Juan del Río, 76800, Mexico
FAICIC
Veracruz, 91900, Mexico
AmdsterdamUMC locatie AMC
Amsterdam, 1105 AZ, Netherlands
Bravis Hospital
Roosendaal, 4708 AE, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Optimal Clinical Trials - Central
Auckland, 1010, New Zealand
Pcrn Chch
Christchurch, 8013, New Zealand
Momentum Clinical Research Dunedin
Dunedin, 9016, New Zealand
Lakeland Clinical Trials - Waikato
Hamilton, 3200, New Zealand
velocity Nova Sp. z o.o.
Nelson, 7011, New Zealand
Pacific Clinical Research Network Rotorua
Rotorua, 3010, New Zealand
Momentum Clinical Research Tauranga
Tauranga, 3110, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, 5018, New Zealand
Klinika Dermatologii i Dermatologii Onkologicznej
Częstochowa, 42-202, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, 42-217, Poland
Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
Elblag, 82-300, Poland
Synexus Polska Sp. z o.o.
Gdansk, 80-382, Poland
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
Grodzisk Mazowiecki, 05-825, Poland
Provita Sp zoo
Katowice, 40-611, Poland
Centrum Medyczne "All-Med" Badania Kliniczne
Krakow, 30-033, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Malopolskie Centrum Alergologii
Krakow, 31-624, Poland
Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
Lodz, 92-213, Poland
Velocity Nova Sp. z o.o.
Lublin, 20-362, Poland
Pro Life Medica ETG Lublin
Lublin, 20-412, Poland
DERMEDIC Iwona Zdybska
Lublin, 20-607, Poland
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin, 20-753, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, 67-100, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401, Poland
Medicome Sp. Z O.O.
Oświęcim, 32-600, Poland
Centrum Alergologii Teresa Hofman Sp. z.o.o.
Poznan, 60-214, Poland
EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
Poznan, 60-309, Poland
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
Poznan, 60-693, Poland
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów, 35-055, Poland
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów, 35-205, Poland
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
Tarnów, 33-100, Poland
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Synexus Polska Sp. z o.o.
Warsaw, 02-672, Poland
ETG Warszawa
Warsaw, 02-677, Poland
MAXDERM s.r.o.
Bardejov, 08501, Slovakia
Derma therapy spol. s.r.o.
Bratislava, 85101, Slovakia
ALERSA, sro
Košice, 04022, Slovakia
Fakultna nemocnica Trnava
Trnava, 91702, Slovakia
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Puerta del Mar
Cadiz, 11009, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital 12 De Octubre
Madrid, 28041, Spain
Clinica Universidad Navarra- Pamplona
Pamplona, 31008, Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital universitario Virgen Macarena
Seville, 41009, Spain
FutureMeds Sevilla
Seville, 41012, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, 28850, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Hospital de Manises
Valencia, 46940, Spain
Siriraj Hospital
Bangkok Noi, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Thammasat University Hospital
Khlong Luang, 12120, Thailand
Khon Kaen University
Khon Kaen, 40002, Thailand
Hôpital Hédi Chaker
Sfax, 3029, Tunisia
La Rabta Hospital
Tunis, 1007, Tunisia
Habib Thameur Hospital
Tunis, 1008, Tunisia
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Cambridge University Hospitals, Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Velocity Clinical Research High Wycombe
High Wycombe, HP11 2QW, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
The Royal London Hospital
London, E1 1FR, United Kingdom
Velocity Clinical Research, North London - PPDS
North Finchley, N12 8BU, United Kingdom
Virtual Clinical Trials Centre, The Stables
Oxford, OX44 9PU, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Velocity Clinical Research - Romford
Romford, RM1 3PJ, United Kingdom
Pinderfields Hospital
Wakefield, WF1 4DG, United Kingdom
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
June 7, 2024
First Posted
June 12, 2024
Study Start
July 19, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03