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Evaluating Dazodalibep for Sjögren's Syndrome with Moderate-to-Severe Symptoms

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 Systemic Disease Activity

Phase 3 Interventional Amgen · NCT06104124

This study is testing a new medication called dazodalibep to see if it can help people with moderate-to-severe Sjögren's Syndrome feel better and manage their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment621 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsrituximab, ocrelizumab, inebilizumab, ofatumumab, ianalumab, belimumab
Locations246 sites (Avondale, Arizona and 245 other locations)
Trial IDNCT06104124 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of dazodalibep in patients diagnosed with Sjögren's Syndrome who exhibit moderate-to-severe systemic disease activity. The primary objective is to assess the drug's impact on systemic manifestations of the condition, while secondary objectives include evaluating patient-reported outcomes and the overall safety and tolerability of the treatment. Participants will be monitored for changes in disease activity using established indices and will receive either the active drug or a placebo during the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Sjögren's Syndrome who have moderate-to-severe systemic disease activity and meet specific inclusion criteria.

Not a fit: Patients with a history of severe cardiovascular issues or active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Sjögren's Syndrome and enhance the quality of life for affected patients.

How similar studies have performed: Other studies have shown promise in treating Sjögren's Syndrome with similar therapeutic approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Avondale, Arizona and 245 other locations

+196 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sjogren's SyndromeSjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity IndexEuropean Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported IndexEuropean Alliance of Associations for Rheumatology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.