A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-Severe Symptom State (HZNP-DAZ-303)
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-Severe Symptom State (HZNP-DAZ-303)
Primary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Secondary Objectives:
Acquired from Horizon in 2024.
Key Inclusion Criteria:
Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
Have an ESSPRI score of ≥ 5 at screening.
Have an ESSDAI score of < 5 at screening.
Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
Meets all of the following tuberculosis (TB) criteria:
Key Exclusion Criteria:
Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
Active malignancy or history of malignancy within the last 5 years, except as follows:
Individuals who are pregnant or lactating or planning to become pregnant during the study.
Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
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.
Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
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.
Individuals with:
Flagstaff, Arizona 86001-6299, United States
Gilbert, Arizona 85297-7338, United States
Glendale, Arizona 85306-9800, United States
Tucson, Arizona 85704-1140, United States
La Jolla, California 92037-1337, United States
Boston, Massachusetts 02111-1552, United States
Saint Clair Shores, Michigan 48081, United States
Kansas City, Missouri 64151-5100, United States
Voorhees Township, New Jersey 08043-4509, United States
Brooklyn, New York 11201-5501, United States
Charlotte, North Carolina 28207-1100, United States
Miamisburg, Ohio 45342-3585, United States
San Antonio, Texas 78229-3901, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1425EOE, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1425EUG, Argentina
Buenos Aires, Ciudad Autónoma de BuenosAires C1121ADC, Argentina
Buenos Aires, Ciudad Autónoma de BuenosAires C1426, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
San Juan, J5400DIL, Argentina
Salvador, Estado de Bahia 40150-150, Brazil
Belo Horizonte, Minas Gerais 30150-221, Brazil
Trois-Rivières, Quebec G9A 3X2, Canada
Viña del Mar, Valparaiso 2520000, Chile
Bad Doberan, Mecklenburg-Vorpommern 18209, Germany
Greifswald Hansestadt, Mecklenburg-Vorpommern 17493, Germany
Chemnitz, 09117, Germany
Budapest, 1097, Hungary
Reggio Emilia, Emilia-Romagna 42121, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Kita Kyushu-shi, Hukuoka 807-8556, Japan
Nishinomiya-Shi, Hyôgo 663-8501, Japan
Sasebo-Shi, Nagasaki 857-1165, Japan
Kurashiki-Shi, Okayama-ken 710-0824, Japan
Iruma-gun, Saitama 350-0495, Japan
Chuo-Ku, Tokyo 104-0044, Japan
Meguro-Ku, Tokyo 152-8902, Japan
Shinjuku-Ku, Tokyo 160-8582, Japan
Torreón Centro, Coahuila 27000, Mexico
Mexicali, Estado de Baja California 21200, Mexico
Americana, Jalisco 44160, Mexico
San Miguel Chapultepec, Mexico City 11850, Mexico
Warsaw, Masovian Voivodeship 02-637, Poland
Malbork, Pomeranian Voivodeship 82-200, Poland
Krakow, 30-363, Poland
Wroclaw, 50-556, Poland
Ponte de Lima, 4990-041, Portugal