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Clinical Trials List

Protocol NumberHZNP-DAZ-301
Active

2023-06-01 - 2026-06-08

Phase III

Recruiting4

ICD-10D89.82

Autoimmune lymphoproliferative syndrome [ALPS]

ICD-10D89.89

Other specified disorders involving the immune mechanism, not elsewhere classified

ICD-9279.4

Autoimmune disease, not elsewhere classified

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

  • Sponsor

    Horizon Therapeutics Ireland DAC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator HSIN-HUA CHEN Division of Rheumatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yao-Fan Fang Division of Rheumatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳正欽 風濕免疫科
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Sjögren’s Syndrome

Objectives

To evaluate the effect of dazodalibep on patient-reported symptoms of Sjögren’s syndrome (SS) in participants with moderate-to-severe symptom state

Test Drug

injection

Active Ingredient

Dazodalibep

Dosage Form

279

Dosage

100mg/ml

Endpoints

 Change from baseline in Diary for Assessing
Sjögren’s Patient Reported Index (DASPRI) score
at Week 48 (Plan A)
 Change from baseline in EULAR Sjögren’s
Syndrome Patient Reported Index (ESSPRI) score
at Week 48 (Plan B)

Inclution Criteria

To be included in this study, individuals must satisfy all the following criteria:
1. Adults, ≥ 18 years at time of informed consent (the minimum age for adult participants
may be greater than 18 years of age in accordance with country-specific age definitions
for adulthood). Participants must be capable of providing their own informed consent.
2. Diagnosed with SS by meeting the 2016 American College of Rheumatology
(ACR)/EULAR Classification Criteria (Section 10.1, Appendix 1). If SS diagnosis is
based on positive anti-Ro autoantibody, anti-Ro positivity must be confirmed by central
lab.
3. Have an ESSPRI score of ≥ 5 at screening despite current or prior symptomatic or local
therapy.
4. Have an ESSDAI score of < 5 at screening.
5. Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening
(as per the definition of the standard central laboratory test).
6. Residual salivary gland function as defined by whole stimulated salivary flow
> 0.1 mL/min.
7. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the US, EU General Data Protection Regulation
[GDPR] in the EU) obtained from the participant prior to performing any protocol-related
procedures, including screening evaluations. Participants must be able to self-complete
Patient-Reported Outcomes (PROs) without assistance.
8. Females of childbearing potential who are sexually active with a nonsterilized male
partner must use a highly effective method of contraception from signing the informed
consent form (ICF) and must agree to continue using such precautions through the end of
the study or 3 months after last IP administration (if participant withdraws from study).
Cessation of contraception after this point should be discussed with a responsible
physician. The Investigator should evaluate the potential for contraceptive method failure

Exclusion Criteria

If an individual meets any of the following criteria, he or she is ineligible for this study:
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:
a. In situ carcinoma of the cervix treated with apparent success with curative therapy
> 12 months prior to screening; OR
b. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant or donate eggs
during the study or for 3 months after the last dose of IP (if participant withdraws from
study).
5. Individuals who have a positive test for hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV) infection.
A positive test for hepatitis B at screening is defined as: (1) positive for hepatitis B
surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb) or
hepatitis B surface antibody (HBsAb) AND hepatitis B virus (HBV) DNA detected above

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    621 participants

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