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

JRCT ID: jRCT2061230107

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sjogren Syndrome
• Date of first enrollment: 15/03/2024
• Target sample size: 33
• Countries of recruitment: North, Central and South America,Japan,Europe,Japan,the Asia-Pacific,Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Change from baseline in ESSDAI score at Week 48

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Key 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 criteria

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, 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

• Primary Sponsor: Shimoyama Michio
• Secondary ID(s): NCT06104124