A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease... | NCT06104124 | Trialant

A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease... | NCT06104124 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Key Inclusion Criteria:

Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.

Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.

Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Key Exclusion Criteria:

Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.

Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.

Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.

Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.

Active TB or untreated (per local guidelines) latent TB

Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.

Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.

Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening.

Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.

Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona 85392, United States

Arizona Research Clinic PLLC

Chandler, Arizona 85225-2915, United States

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln

Flagstaff, Arizona 86001-6299, United States

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St

Gilbert, Arizona 85297-7338, United States

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln

Glendale, Arizona 85306-9800, United States

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd

Tucson, Arizona 85704-1140, United States

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, California 92037-1337, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California 91786-4951, United States

Tekton Research, LLC - 2121 E Harmony Rd - PPDS

Fort Collins, Colorado 80528-3404, United States

Bradenton Research Center Inc

Bradenton, Florida 34205-1704, United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida 33765-2616, United States

University of Miami - Leonard M. Miller School of Medicine

Miami, Florida 33136-1011, United States

Suncoast Clinical Research - ATLAS - New Port Richey - PPDS

New Port Richey, Florida 34652-4020, United States

Millennium Research

Ormond Beach, Florida 32174-1140, United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida 33321-2956, United States

BayCare Medical Group

Tampa, Florida 33614-7101, United States

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia 30912-0004, United States

OrthoIllinois, LTD

Rockford, Illinois 61114-4937, United States

University of Kansas Medical Center

Kansas City, Kansas 66160-0001, United States

Massachusetts General Hospital

Boston, Massachusetts 02114-2621, United States

Clinical Research Institute of Michigan, LLC-St. Claire Shores

Saint Clair Shores, Michigan 48081, United States

Kansas City Physician Partners-8350 N Saint Clair Ave

Kansas City, Missouri 64151-5100, United States

Arthritis, Rheumatic & Bone Disease Associates - P

Voorhees Township, New Jersey 08043-4509, United States

NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York 11201-5501, United States

Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd

Charlotte, North Carolina 28207, United States

Duke Early Phase Clinical Research Unit - PPDS

Durham, North Carolina 27710-0001, United States

Onsite Clinical Solutions, LLC - Salisbury

Salisbury, North Carolina 28144, United States

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

Miamisburg, Ohio 45342, United States

University of Toledo Medical Center

Toledo, Ohio 43614-2595, United States

STAT Research-600 Aviator Ct

Vandalia, Ohio 45377-9474, United States

Low Country Rheumatology PA-Summerville

Summerville, South Carolina 29486-7887, United States

Murfreesboro Medical Clinic Westlawn

Murfreesboro, Tennessee 37128, United States

Amarillo Center For Clinical Research

Amarillo, Texas 79124-1601, United States

Tekton Research, LLC - W Gate Blvd - Austin - PPDS

Austin, Texas 78745-1470, United States

Accurate Clinical Management-Baytown

Baytown, Texas 77521, United States

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas 76051-3143, United States

Prolato Clinical Research Center

Houston, Texas 77054-2853, United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas 77450, United States

Valley Arthritis Center

McAllen, Texas 78501, United States

University of Texas - San Antonio - Health Science Center - PPDS

San Antonio, Texas 78229-3901, United States

DM Clinical Research - Migraine and COPD - PPDS

Tomball, Texas 77375, United States

Metrodora Institute

West Valley City, Utah 84119, United States

Overlake Arthritis & Osteoporosis Center

Bellevue, Washington 98004-3016, United States

Western Washington Medical Group, Bothell - Rheumatology

Bothell, Washington 98021, United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia 25801-2805, United States

Sanatorio Agote - Swiss Medical Group - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires C1425EOE, Argentina

Framingham Centro Médico

La Plata, Buenos Aires B1900, Argentina

Instituto CER S.A.

Quilmes, Buenos Aires B1878DVB, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires B1878GEG, Argentina

MR Medicina Reumatologica

San Fernando, Buenos Aires B1646GHP, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Ciudad Autónoma de BuenosAires C1121ADC, Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires C1128AAF, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires C1417, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires C1426ABP, Argentina

Sanatorio Allende S.A

Córdoba, Córdoba Province X5000JHGQ, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province T4000IHE, Argentina

DOM Centro de Reumatología

Buenos Aires, C1111AAH, Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Buenos Aires, C1406AGA, Argentina

Centro Medico Arsema

Buenos Aires, C1427CCL, Argentina

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

San Juan, J5400DIL, Argentina

The Queen Elizabeth Hospital

Woodville South, South Australia 5011, Australia

UZ Gent

Ghent, Oost-Vlaanderen 9000, Belgium

UZ Leuven

Leuven, Vlaams Brabant 3000, Belgium

SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

Salvador, Estado de Bahia 40150-150, Brazil

AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia

Brasília, Federal District 70200-730, Brazil

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais 30150-221, Brazil

Centro Mineiro de Pesquisa - CMiP

Juiz de Fora, Minas Gerais 36010-570, Brazil

Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná 80030-110, Brazil

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul 90480-000, Brazil

Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille

Trois-Rivières, Quebec G9A 3X2, Canada

Centro de especialidades médicas Vanguardia

Temuco, Araucania 4780000, Chile

Clinical Research Chile SpA - PPDS

Valdivia, Los Ríos Region 5110683, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia, Región-MetropolitanadeSantiago 7500587, Chile

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago 8320000, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Valparaiso 2520000, Chile

Clinical Center Zagreb - Oncology - Salata 7 - PPDS

Zagreb, City of Zagreb 10000, Croatia

Polyclinic Bonifarm

Zagreb, City of Zagreb 10000, Croatia

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

University Hospital of Split-Spinciceva 1

Split, 21000, Croatia

Hopital Emile Muller

Mulhouse, Haut-Rhin 68100, France

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, 33000, France

CHU de Brest - Hôpital La Cavale Blanche

Brest, 29609, France

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67200, France

Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan

Bad Doberan, Mecklenburg-Vorpommern 18209, Germany

Rheumazentrum Greifswald

Greifswald Hansestadt, Mecklenburg-Vorpommern 17493, Germany

DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, 09117, Germany

MVZ Rheuma

Hamburg, 20095, Germany

Olympion General Clinic

Kato Sychena Patras, Achaïa 264 43, Greece

Naval Hospital of Athens

Athens, Attica 115 21, Greece

Laiko General Hospital of Athens

Athens, Attica 115 27, Greece

University General Hospital of Larissa

Larissa, Larisa 411 10, Greece

Euromedica Kianous Stavros

Thessaloniki, 546 36, Greece

Bekes Varmegyei Kozponti Korhaz

Gyula, Bekes County 5700, Hungary

Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, Csongrád megye 6800, Hungary

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar 4032, Hungary

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7

Budapest, 1097, Hungary

Meir Medical Center

Kfar Saba, Central District 44281, Israel

The Chaim Sheba Medical Center - PPDS

Ramat Gan, 5262100, Israel

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna 42121, Italy

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia 33100, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio 00128, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio 00168, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122, Italy

A.O.U. Città della Salute e della Scienza di Torino

Turin, Piedmont 10126, Italy

AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco

Catania, Sicily 95121, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany 50134, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany 56126, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto 37134, Italy

Chubu Rosai Hospital

Nagoya, Aiti 455-0018, Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya, Aiti 457-0866, Japan

Daido Clinic

Nagoya, Aiti 457-8511, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaidô 060-8543, Japan

Hokkaido University Hospital

Sapporo, Hokkaidô 060-8648, Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kita Kyushu-shi, Hukuoka 807-8556, Japan

Hyogo Medical University Hospital

Nishinomiya-Shi, Hyôgo 663-8501, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki 305-8576, Japan

Kanazawa Medical University Hospital

Kahoku, Ishikawa-ken 920-0293, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken 920-8641, Japan

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa 245-8575, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyôto 602-8566, Japan

Kyoto University Hospital

Kyoto, Kyôto 606-8507, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki 852-8501, Japan

Sasebo Chuo Hospital

Sasebo-Shi, Nagasaki 857-1165, Japan

Kurashiki Medical Clinic

Kurashiki-Shi, Okayama-ken 710-0824, Japan

Saitama Medical University Hospital

Iruma-gun, Saitama 350-0495, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka 431-3192, Japan

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo 113-8603, Japan

St. Luke's International Hospital

Chuo-Ku, Tokyo 104-0044, Japan

Tokyo Medical Center

Meguro-Ku, Tokyo 152-8902, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo 160-8582, Japan

Nihon University Itabashi Hospital

tabashi City, Tokyo 173-8610, Japan

Mediadvance Clinical S.A.P.I. de C.V.

Parques de San Felipe, Chihuahua 31203, Mexico

ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C

Saltillo, Coahuila 25279, Mexico

CIMAB SA de CV

Torreón Centro, Coahuila 27000, Mexico

Centro de Investigación en Artritis y Osteoporosis - PPDS

Mexicali, Estado de Baja California 21200, Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco 44690, Mexico

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS

Guadalajara, Jalisco ZC 44160, Mexico

Cryptex Investigación Clínica, S.A. de C.V.

Mexico City, Mexico City 06100, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel Chapultepec, Mexico City 11850, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán 97000, Mexico

Centro de Investigacion Farmacologica Del Bajio Sc

León, 37160, Mexico

Consultorio de Reumatologia

México, 07760, Mexico

Clinstile, S.A. de C.V.

México, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, 64460, Mexico

Accelerium, S. de R.L. de C.V. - PPDS

Monterrey, 64000, Mexico

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, 68000, Mexico

Optimal Clinical Trials Ltd - PPDS

Auckland, 1003, New Zealand

Aotearoa Clinical Trials Trust

Auckland, 2025, New Zealand

Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)

Hamilton, 3214, New Zealand

Clinica San Antonio S.A.C

Trujillo, La Libertad 13008, Peru

Clinica San Juan Bautista

San Juan de Lurigancho, Lima region 15431, Peru

Hogar Clinica San Juan de Dios - Arequipa

Arequipa, 04013, Peru

Hospital Militar Central Luis Arias Schereiber

Lima, 11, Peru

Clínica Internacional San Borja-Avenida Guardia Civil 385

Lima, 15001, Peru

Instituto de Ginecologia y Reproduccion - PPDS

Lima, Lima 33, Peru

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

Pueblo Libre, Lima 21, Peru

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship 60-192, Poland

Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship 60-693, Poland

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Greater Poland Voivodeship 61-397, Poland

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship 30-149, Poland

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship 52-416, Poland

Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej

Wroclaw, Lower Silesian Voivodeship 54-049, Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship 20-412, Poland

Reumed Sp. z o.o.

Lublin, Lublin Voivodeship 20-607, Poland

FutureMeds - Warszawa Centrum - PPDS

Warsaw, Masovian Voivodeship 00-215, Poland

MICS Centrum Medyczne Warszawa - MICS - PPDS

Warsaw, Masovian Voivodeship 00-874, Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship 02-172, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

Warsaw, Masovian Voivodeship 02-637, Poland

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, Masovian Voivodeship 02-665, Poland

FutureMeds - Targowek - PPDS

Warsaw, Masovian Voivodeship 03-291, Poland

K2J2 Medical Center

Wołomin, Masovian Voivodeship 05-200, Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

Malbork, Pomeranian Voivodeship 82-200, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Centrum Medyczne Pratia Katowice - PPDS

Katowice, 40-081, Poland

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

Krakow, 30-363, Poland

Centrum Medyczne PROMED- Olszanska 5G

Krakow, 31-513, Poland

FutureMeds - Lodz - PPDS

Lodz, 91-363, Poland

Twoja Przychodnia PCM

Poznan, 60-324, Poland

ETG Warszawa - PPDS

Warsaw, 02-677, Poland

WIM-PIB, Centralny Szpital Kliniczny MON

Warsaw, 04-141, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213

Wroclaw, 50-556, Poland

Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3

Wroclaw, 53-034, Poland

FutureMeds - Wroclaw - PPDS

Wroclaw, 53-673, Poland

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Lisbon District 1349-019, Portugal

Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima

Ponte de Lima, Viana do Castelo District 4990-041, Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS

Lisbon, 1649-035, Portugal

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia, 4434-502, Portugal

GCM Medical Group, PSC -62 Calle Jose Marti

San Juan, 00917, Puerto Rico

Institute of Rheumatology - PPDS

Belgrade, 11000, Serbia

Military Medical Academy

Belgrade, 11000, Serbia

University Clinical Center of Serbia - Pasterova 2 - PPDS

Belgrade, 11000, Serbia

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

Special Hospital For Rheumatic Diseases Novi Sad

Novi Sad, 21000, Serbia

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba 14004, Spain

Hospital Regional Universitario de Malaga - Hospital Civil

Málaga, Málaga 29009, Spain

Hospital Universitario de Basurto

Bilbao, 48013, Spain

Hospital Universitario Infanta Leonor

Madrid, 28032, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Fundacio Hospital de l'Esperit Sant

Santa Coloma de Gramenet(Barcelona), 08923, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

Chang Gung Memorial Hospital, Linkou

Gui Shan Qu, 333, Taiwan

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Taipei Medical University Hospital - PPDS

Taipei, 11031, Taiwan

Chapel Allerton Hospital - PPDS

Leeds, LS7 4SA, United Kingdom

William Harvey Research Institute - PPDS

London, EC1M 6BQ, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Queen Alexandra Hospital

Portsmouth, P06 3LY, United Kingdom