NIPH Clinical Trials Search

JRCT ID: jRCT2061230107

Registered date:12/03/2024

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjogren Syndrome With Moderate-to-severe Systemic Disease Activity

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSjogren Syndrome
Date of first enrollment15/03/2024
Target sample size33
Countries of recruitmentNorth, Central and South America,Japan,Europe,Japan,the Asia-Pacific,Japan
Study typeInterventional
Intervention(s)Participants will be randomized (1 to 1 to 1)to Dazodalibep Dose 1, Dazodalibep Dose 2, or placebo as follows. Experimental: Dazodalibep Dose 1 Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion. Interventions Drug: Dazodalibep Experimental: Dazodalibep Dose 2 Participants will be administered dose 2 of dazodalibep,placebo by IV infusion. Interventions Drug: Dazodalibep, Plasebo Placebo Comparator: Placebo Participants will be administered placebo by IV infusion. Interventions Drug: Placebo Participants will receive a total of 13 doses until experiencing unacceptable toxicity, withdrawal of consent, or discontinuation for any other reason during the clinical trial.


Primary OutcomeChange from baseline in ESSDAI score at Week 48
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteriaKey Inclusion Criteria: : Diagnosed with Sjogren 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 Sjogren 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).
Exclude criteriaKey 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, or have been treated for, hepatitis B, hepatitis C (unless they have undergone hepatitis C antiviral treatment and have undetectable viral level of hepatitis C RNA at least 24 weeks following completion of therapy) or human immunodeficiency virus (HIV) infection. 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.

Related Information


Public contact
Name Michio Shimoyama
Address 2-2-7, Nakanoshima, Kita-ku, Osaka Osaka Japan 530-0005
Telephone +81-90-4833-6595
Affiliation CMIC Co., Ltd.
Scientific contact
Name Michio Shimoyama
Address 2-2-7, Nakanoshima, Kita-ku, Osaka Osaka Japan 530-0005
Telephone +81-90-4833-6595
Affiliation CMIC Co., Ltd.