A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Launched by AMGEN · Oct 23, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called dazodalibep to see how well it works for people with Sjögren's syndrome (SS), especially those who have moderate to severe symptoms affecting their overall health. The main goal is to find out if dazodalibep can improve the symptoms of SS that affect the body as a whole, as well as to hear directly from patients about how they feel while taking this medication. Additionally, the study will monitor the safety of dazodalibep to ensure it can be tolerated by participants.
To be eligible for this trial, participants must be diagnosed with Sjögren's syndrome according to specific guidelines and show a certain level of disease activity despite other treatments. They should also test positive for specific autoantibodies. However, individuals with certain serious health conditions, like recent blood clots or certain cancers, will not be able to participate. Those who join the study can expect regular check-ins to assess their health and how they respond to the treatment. This trial is currently looking for volunteers of all genders, aged 65 to 74.
Gender
ALL
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.
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Madrid, , Spain
Newcastle Upon Tyne, , United Kingdom
Woodville South, South Australia, Australia
Santa Cruz De Tenerife, , Spain
Taichung, , Taiwan
Sevilla, , Spain
Shinjuku Ku, Tokyo, Japan
Sevilla, , Spain
Tamarac, Florida, United States
Curitiba, Paraná, Brazil
Gwangju, , Korea, Republic Of
Leeds, , United Kingdom
Bunkyo Ku, Tokyo, Japan
Belgrade, , Serbia
Kansas City, Kansas, United States
Maribor, , Slovenia
Novi Sad, , Serbia
Heidelberg, , Germany
Charlotte, North Carolina, United States
Madrid, , Spain
Ljubljana, , Slovenia
Bydgoszcz, , Poland
Nottingham, , United Kingdom
A Coruña, , Spain
Valencia, , Spain
Verona, , Italy
Novi Sad, , Serbia
Strasbourg, , France
Seoul, , Korea, Republic Of
Sapporo Shi, , Japan
Kyoto Shi, , Japan
Elblag, , Poland
Mexico, , Mexico
Sevilla, , Spain
Gent, Oost Vlaanderen, Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Leuven, Vlaams Brabant, Belgium
Taipei, , Taiwan
Osijek, , Croatia
Cordoba, , Spain
Iruma Gun, Saitama, Japan
Kragujevac, , Serbia
Torino, Piemonte, Italy
Hamburg, , Germany
London, , United Kingdom
Meguro Ku, Tokyo, Japan
Nagasaki Shi, Nagasaki, Japan
Guadalajara, Jalisco, Mexico
Poznan, Wielkopolskie, Poland
Kyoto Shi, , Japan
Juiz De Fora, Minas Gerais, Brazil
Milano, Lombardia, Italy
Merida, Yucatán, Mexico
Cordoba, Córdoba, Spain
Tomball, Texas, United States
Firenze, Toscana, Italy
Sabadell, Barcelona, Spain
Salvador, Bahia, Brazil
Madrid, , Spain
Kurashiki Shi, Okayama, Japan
Tsukuba Shi, Ibaraki, Japan
Mexico, , Mexico
Wroclaw, Dolnoslaskie, Poland
Le Kremlin Bicêtre, , France
Bydgoszcz, , Poland
Quilmes, Buenos Aires, Argentina
Bilbao, , Spain
Ciudad Autónoma De Buenos Aires, , Argentina
Kfar Sava, Hamerkaz, Israel
Suwon Si, , Korea, Republic Of
Clearwater, Florida, United States
Szczecin, Zachodniopomorskie, Poland
Mexicali, Baja California, Mexico
Sapporo Shi, Hokkaidô, Japan
Roma, Lazio, Italy
Bordeaux, , France
Lublin, Lubelskie, Poland
Nishinomiya Shi, , Japan
Jerusalem, Yerushalayim, Israel
Skórzewo, Wielkopolskie, Poland
West Valley City, Utah, United States
Roma, Lazio, Italy
Itabashi, Tokyo, Japan
Udine, Friuli Venezia Giulia, Italy
Warszawa, Mazowieckie, Poland
La Plata, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Gyula, , Hungary
Katowice, , Poland
San Miguel Chapultepec, Distrito Federal, Mexico
Merida, , Mexico
Athina, Attiki, Greece
Warszawa, Mazowieckie, Poland
Heidelberg, Baden Württemberg, Germany
Viña Del Mar, Valparaíso, Chile
Kraków, Malopolskie, Poland
łódź, , Poland
Luton, Bedfordshire, United Kingdom
Monterrey, , Mexico
Beverly Hills, California, United States
Upland, California, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Saint Clair Shores, Michigan, United States
Voorhees, New Jersey, United States
Amarillo, Texas, United States
Baytown, Texas, United States
Chuo Ku, Tokyo, Japan
Mitras Centro, , Mexico
Nishinomiya Shi, Hyôgo, Japan
Yokohama Shi, Kanagawa, Japan
Auckland, , New Zealand
Chandler, Arizona, United States
Flagstaff, Arizona, United States
Fort Collins, Colorado, United States
Voorhees, New Jersey, United States
Dayton, Ohio, United States
Bothell, Washington, United States
Bothell, Washington, United States
Chandler, Arizona, United States
Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Fort Collins, Colorado, United States
New Port Richey, Florida, United States
Tamarac, Florida, United States
Miamisburg, Ohio, United States
Vandalia, Ohio, United States
Mcallen, Texas, United States
Tomball, Texas, United States
Voorhees, New Jersey, United States
Novara, Piemonte, Italy
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Salisbury, North Carolina, United States
Katy, Texas, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Trois Rivières, Quebec, Canada
Kurashiki Shi, Okayama, Japan
Gwangju, Gwangju Gwang'yeogsi, Korea, Republic Of
Namdong Gu, , Korea, Republic Of
Jackson, Tennessee, United States
San Miguel De Tucumán, Tucumán, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Debrecen, Hajdú Bihar, Hungary
Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Beckley, West Virginia, United States
Fort Collins, Colorado, United States
Boston, Massachusetts, United States
Baytown, Texas, United States
Grapevine, Texas, United States
Katy, Texas, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Nagoya Shi, Aiti, Japan
Sasebo Shi, Nagasaki, Japan
Hamamatsu City, Sizuoka, Japan
Tomball, Texas, United States
San Miguel De Tucumán, Tucumán, Argentina
Thessaloniki, , Greece
Belgrade, , Serbia
Nagoya Shi, Aiti, Japan
Malaga, , Spain
Zagreb, Grad Zagreb, Croatia
Pisa, Toscana, Italy
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
San Miguel De Tucuman, Tucumán, Argentina
Sapporo Shi, Hokkaidô, Japan
Quilmes, Buenos Aires, Argentina
Catania, Sicilia, Italy
Athina, Attiki, Greece
Belgrade, , Serbia
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Poznań, Wielkopolskie, Poland
Denver, Colorado, United States
Salisbury, North Carolina, United States
Nagoya, Aiti, Japan
Kita Kyushu Shi, Hukuoka, Japan
Kahoku Shi, Isikawa, Japan
Kyoto Shi, Kyôto, Japan
Kyoto Shi, Kyôto, Japan
Santa Coloma De Gramenet(barcelona), , Spain
Ormond Beach, Florida, United States
Voula, Attiki, Greece
Hamilton, , New Zealand
Vila Nova De Gaia, , Portugal
San Juan, , Puerto Rico
Zagreb, Grad Zagreb, Croatia
Kanazawa Shi, Isikawa, Japan
Houston, Texas, United States
San Antonio, Texas, United States
Temuco, Araucanía, Chile
Santiago, Región Metropolitanadesantiago, Chile
Fort Collins, Colorado, United States
Buenos Aires, , Argentina
Split, , Croatia
Bad Doberan, Mecklenburg Vorpommern, Germany
Alessandria, Piemonte, Italy
Toledo, Ohio, United States
Chemnitz, , Germany
Larissa, Larisa, Greece
Hódmezővásárhely, Csongrád, Hungary
Lublin, Lubelskie, Poland
Malbork, Pomorskie, Poland
Wrocław, , Poland
Lisboa, , Portugal
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
La Jolla, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Rockford, Illinois, United States
Brooklyn, New York, United States
Miamisburg, Ohio, United States
Katy, Texas, United States
Bothell, Washington, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Recoleta, Ciudad Autónoma De Buenosaires, Argentina
Ciudad De Cordoba, Córdoba, Argentina
San Juan, , Argentina
Belo Horizonte, Minas Gerais, Brazil
Trois Rivieres, Quebec, Canada
Valdivia, Los Ríos, Chile
Providencia, Región Metropolitanadesantiago, Chile
Santiago, Región Metropolitanadesantiago, Chile
Zagreb, Grad Zagreb, Croatia
Mulhouse, Haut Rhin, France
Brest, , France
Paris, , France
Jerusalem, Yerushalayim, Israel
Ramat Gan, , Israel
Milano, Lombardia, Italy
Ciudad De México, Distrito Federal, Mexico
Oaxaca, , Mexico
Auckland, , New Zealand
Trujillo, La Libertad, Peru
Lima, , Peru
Pueblo Libre, , Peru
Wrocław, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Wołomin, Mazowieckie, Poland
Kraków, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Wrocław, , Poland
Lisbon, Lisboa, Portugal
Ponte De Lima, Viana Do Castelo, Portugal
Vitoria, álava, Spain
Gui Shan Qu, , Taiwan
Kaohsiung City, , Taiwan
Poznan, Wielkopolskie, Poland
Budapest, , Hungary
Lima, , Peru
Lima, , Peru
Lima, , Peru
Portsmouth, , United Kingdom
Durham, North Carolina, United States
Greifswald Hansestadt, Mecklenburg Vorpommern, Germany
Gyula, Békés, Hungary
Reggio Emilia, Emilia Romagna, Italy
Guadalajara, Jalisco, Mexico
Elblag, , Poland
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Parques De San Felipe, Chihuahua, Mexico
Arequipa, , Peru
London, Camden, United Kingdom
Ciudad Autónoma De Buenos Aires, , Argentina
Murfreesboro, Tennessee, United States
Zagreb, Grad Zagreb, Croatia
Torreón Centro, Coahuila, Mexico
Phoenix, Arizona, United States
Augusta, Georgia, United States
Vina Del Mar, Valparaíso, Chile
Odense C, South Denmark, Denmark
Roma, Lazio, Italy
Poznań, , Poland
Wrocław, , Poland
San Juan De Lurigancho, Lima, Peru
Warszawa, Mazowieckie, Poland
Poznan, Wielkopolskie, Poland
Santa Cruz De Tenerife., , Spain
San Fernando, Buenos Aires, Argentina
Phoenix, Arizona, United States
Saltillo, Coahuila, Mexico
Austin, Texas, United States
Bellevue, Washington, United States
Leon, , Mexico
Castellón, , Spain
Ciudad Autónoma De Buenos Aires, , Argentina
Saint Priest En Jarez, Loire, France
Kraków, , Poland
Warszawa, , Poland
Avondale, Arizona, United States
Coral Gables, Florida, United States
Las Vegas, Nevada, United States
Salisbury, North Carolina, United States
Summerville, South Carolina, United States
Budapest, , Hungary
Civitavecchia Rm, , Italy
Lublin, Lubelskie, Poland
Poznan, Wielkopolskie, Poland
Malaga, Málaga, Spain
Taipei, , Taiwan
Patra, Achaïa, Greece
Seoul, , Korea, Republic Of
Valdivia, , Chile
Debrecen, , Hungary
Curitiba, , Brazil
Ciudad Autónoma De Buenos Aires, , Argentina
Ciudad De Cordoba, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucumán, , Argentina
San Miguel De Tucumán, , Argentina
Sapporo Shi, , Japan
Boston, Massachusetts, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Brasília, Distrito Federal, Brazil
Temuco, , Chile
Providencia, , Chile
Santiago, , Chile
Vina Del Mar, , Chile
Patra, , Greece
Hódmezővásárhely, , Hungary
Poznań, , Poland
Vitoria, , Spain
Luton, Bedfordshire, United Kingdom
London, Camden, United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Kato Sychena Patras, , Greece
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported