A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Launched by AMGEN · Jan 30, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called dazodalibep for patients with Sjögren's Syndrome (SS), specifically those who experience moderate to severe symptoms. The main goal is to see how well dazodalibep helps improve the symptoms reported by patients. Additionally, researchers will look at other effects of the treatment, including its impact on overall health, saliva production, and how well patients tolerate the medication.
To participate in this trial, individuals must be diagnosed with Sjögren's Syndrome and meet specific criteria, such as having certain test results that confirm the condition. They should also have some remaining salivary gland function and be vaccinated against COVID-19. Participants can expect to receive multiple doses of dazodalibep and will be closely monitored for any side effects throughout the study. This trial is currently recruiting participants aged 65 to 74, and it’s important for anyone considering participation to discuss their medical history with their healthcare provider to ensure they meet the eligibility requirements.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
- • 2. Have an ESSPRI score of ≥ 5 at screening.
- • 3. Have an ESSDAI score of \< 5 at screening.
- • 4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
- • 5. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min.
- • 6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
- 7. Meets all of the following tuberculosis (TB) criteria:
- • 1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
- • 2. No signs or symptoms suggestive of active TB from medical history or physical examination.
- • 3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
- • 4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
- • 5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
- Key Exclusion Criteria:
- • 1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
- • 2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
- 3. Active malignancy or history of malignancy within the last 5 years, except as follows:
- • 1. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR
- • 2. Cutaneous basal cell carcinoma following presumed curative therapy.
- • 4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
- • 5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
- • 6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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.
- • 7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
- • 8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.
- 9. Individuals with:
- • 1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
- • 2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 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
Madrid, , Spain
Gent, , Belgium
Woodville South, South Australia, Australia
Shinjuku Ku, Tokyo, Japan
Sevilla, , Spain
Madrid, , Spain
Curitiba, Paraná, Brazil
Gwangju, , Korea, Republic Of
Leeds, , United Kingdom
Taipei, , Taiwan
Belgrade, , Serbia
Maribor, , Slovenia
Incheon, , Korea, Republic Of
Novi Sad, , Serbia
Heidelberg, , Germany
Madrid, , Spain
Bydgoszcz, , Poland
A Coruña, , Spain
Valencia, , Spain
Novi Sad, , Serbia
Strasbourg, , France
Seoul, , Korea, Republic Of
Sapporo Shi, , Japan
Kyoto Shi, , Japan
Mexico, , Mexico
Sevilla, , Spain
Whittier, California, United States
Bilbao, Vizcaya, Spain
Osijek, , Croatia
Cordoba, , Spain
Taoyuan City, , Taiwan
Mulhouse, , France
Iruma Gun, Saitama, Japan
Kragujevac, , Serbia
Torino, Piemonte, Italy
Taichung City, , Taiwan
Hamburg, , Germany
London, , United Kingdom
Meguro Ku, Tokyo, Japan
Nagasaki Shi, Nagasaki, Japan
Guadalajara, Jalisco, Mexico
Poznan, Wielkopolskie, Poland
Kyoto Shi, , Japan
Verona, Veneto, Italy
The Woodlands, Texas, United States
Milano, Lombardia, Italy
Cordoba, Córdoba, Spain
Firenze, Toscana, Italy
Salvador, Bahia, Brazil
Kurashiki Shi, Okayama, Japan
Tsukuba Shi, Ibaraki, Japan
Kaohsiung, , Taiwan
Wroclaw, Dolnoslaskie, Poland
Quilmes, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Clearwater, Florida, United States
Poznań, Wielkopolskie, Poland
Szczecin, Zachodniopomorskie, Poland
Mexicali, Baja California, Mexico
Sapporo Shi, Hokkaidô, Japan
Roma, Lazio, Italy
Bordeaux, , France
Kansas City, Kansas, United States
Tomball, Texas, United States
Lublin, Lubelskie, Poland
Nishinomiya Shi, , Japan
Roma, Lazio, Italy
Itabashi, Tokyo, Japan
Udine, Friuli Venezia Giulia, Italy
Warszawa, Mazowieckie, Poland
La Plata, Buenos Aires, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Gyula, , Hungary
Katowice, , Poland
Merida, , Mexico
Athina, Attiki, Greece
Warszawa, Mazowieckie, Poland
Heidelberg, Baden Württemberg, Germany
Kraków, Malopolskie, Poland
łódź, , Poland
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
Amarillo, Texas, United States
Baytown, Texas, United States
Chuo Ku, Tokyo, Japan
Nishinomiya Shi, Hyôgo, Japan
Yokohama Shi, Kanagawa, Japan
Auckland, , New Zealand
Dayton, Ohio, United States
Chandler, Arizona, United States
Tamarac, Florida, United States
Miamisburg, Ohio, United States
Vandalia, Ohio, United States
Mcallen, Texas, United States
Voorhees, New Jersey, United States
Novara, Piemonte, Italy
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Katy, Texas, United States
San Miguel De Tucumán, Tucumán, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Ponte De Lima, , Portugal
Debrecen, Hajdú Bihar, Hungary
Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Tomball, Texas, United States
Beckley, West Virginia, United States
Fort Collins, Colorado, United States
Grapevine, Texas, United States
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
Baytown, Texas, United States
Nagoya Shi, Aiti, Japan
Zagreb, Grad Zagreb, Croatia
Pisa, , Italy
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Valdivia, Los Ríos, Chile
Sapporo Shi, Hokkaidô, Japan
Quilmes, Buenos Aires, Argentina
Athina, Attiki, Greece
Warszawa, Mazowieckie, Poland
Poznań, Wielkopolskie, Poland
Covina, California, United States
Denver, Colorado, United States
Tampa, Florida, United States
Salisbury, North Carolina, United States
Katy, Texas, United States
Katy, Texas, United States
Bothell, Washington, United States
Trois Rivieres, Quebec, Canada
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
Ponte De Lima, , Portugal
Albuquerque, New Mexico, United States
Voula, Attiki, Greece
Auckland, North Island, New Zealand
Hamilton, , New Zealand
Lisboa, , Portugal
Vila Nova De Gaia, , Portugal
San Juan, , Puerto Rico
Zagreb, Grad Zagreb, Croatia
Kanazawa Shi, Isikawa, Japan
San Antonio, Texas, United States
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Boston, Massachusetts, United States
Fort Collins, Colorado, United States
Buenos Aires, , Argentina
Peñalolén, Región Metropolitanadesantiago, Chile
Santiago, Región Metropolitanadesantiago, Chile
Split, , Croatia
Bad Doberan, Mecklenburg Vorpommern, Germany
Alessandria, Piemonte, Italy
Toledo, Ohio, United States
Chemnitz, , Germany
Larissa, Larisa, Greece
Hódmezővásárhely, Csongrád, Hungary
Milano, , Italy
Ciudad De México, Distrito Federal, Mexico
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Malbork, Pomorskie, Poland
Wrocław, , Poland
Lisboa, , Portugal
La Jolla, California, United States
Miami, Florida, United States
Rockford, Illinois, United States
Brooklyn, New York, 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
San Juan, , Argentina
Belo Horizonte, Minas Gerais, Brazil
Brest, , France
Paris, , France
Lima, , Peru
Pueblo Libre, , Peru
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Kraków, , Poland
Warszawa, , Poland
Vitoria, álava, Spain
Bologna, Emilia Romagna, Italy
Budapest, , Hungary
Lima, , Peru
Lima, , Peru
Lima, , Peru
Durham, North Carolina, United States
Greifswald Hansestadt, Mecklenburg Vorpommern, Germany
Gyula, Békés, Hungary
Reggio Emilia, Emilia Romagna, Italy
Elblag, , Poland
Arequipa, , Peru
London, Camden, United Kingdom
Zagreb, Grad Zagreb, Croatia
Córdoba, , Argentina
Trois Rivières, Quebec, Canada
Catania, , Italy
Americana, Jalisco, Mexico
Wroclaw, Dolnoslaskie, Poland
Wroclaw, Dolnoslaskie, Poland
Wolomin, Mazowieckie, Poland
Wrocław, , Poland
Ljubljana, , Slovenia
La Laguna, , Spain
Taichung City, , Taiwan
Vina Del Mar, Valparaíso, Chile
Odense C, South Denmark, Denmark
Roma, Lazio, Italy
Poznań, , Poland
Wroclaw, Dolnoslaskie, Poland
San Juan De Lurigancho, Lima, Peru
Warszawa, Mazowieckie, Poland
Trujillo, , Peru
Santa Cruz De Tenerife., , Spain
Ciudad Autónoma De Buenos Aires, , Argentina
Salisbury, North Carolina, United States
Budapest, , Hungary
Lublin, Lubelskie, Poland
Seoul, , Korea, Republic Of
Poznań, Wielkopolskie, Poland
Taipei, , Taiwan
Mitras Centro, , Mexico
Debrecen, , Hungary
Curitiba, , Brazil
San Miguel De Tucumán, , Argentina
San Miguel De Tucumán, , Argentina
San Miguel De Tucumán, , Argentina
Sapporo Shi, , Japan
Ciudad Autónoma De Buenos Aires, , Argentina
Vina Del Mar, , Chile
Hódmezővásárhely, , Hungary
Poznań, , Poland
Vitoria, , Spain
London, Camden, United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Ciudad Autónoma De Buenos Aires, , Argentina
Valdivia, , Chile
Peñalolén, , Chile
Santiago, , Chile
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported