Clinical Trials List
Protocol NumberHZNP-DAZ-303
NCT Number(ClinicalTrials.gov Identfier)NCT06245408
Active
2024-02-12 - 2026-06-01
Phase III
Recruiting5
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjogren's Syndrome With Moderate-to-Severe Symptom State
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Sponsor
PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 高宗楙 Division of Rheumatology
- 陳彥如 Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- 顏在弘 Division of Rheumatology
- 林靖才 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- Yi-Hsing Chen Division of Rheumatology
- 廖育婉 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林科宏 Division of Rheumatology
- 林韋睿 Division of Rheumatology
- Tzn-Min Lin Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 張詩欣 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 歐燦騰 風濕免疫科
- Jeng-Hsien Yen 風濕免疫科
- Chia-Chun Tseng 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yao-Fan Fang
Co-Principal Investigator
- 陳彥輔 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- 張哲慈 Division of Rheumatology
- Shue-Fen Lo Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Sjogren's Syndrome
Objectives
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Test Drug
Dazodalibep
Active Ingredient
Dazodalibep
Dosage Form
Solution
Dosage
500mg/5ml
Endpoints
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
Change from baseline in ESSPRI score
Change from baseline in ESSPRI score
Inclution Criteria
Key Inclusion Criteria:
1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
2. Have an ESSPRI score of ≥ 5 at screening.
3. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
7. Meets all of the following tuberculosis (TB) criteria:
1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
2. No signs or symptoms suggestive of active TB from medical history or physical examination.
3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
2. Have an ESSPRI score of ≥ 5 at screening.
3. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
7. Meets all of the following tuberculosis (TB) criteria:
1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
2. No signs or symptoms suggestive of active TB from medical history or physical examination.
3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
Exclusion Criteria
Key Exclusion Criteria:
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:
1. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR
2. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
6. 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.
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
8. 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.
9. Individuals with:
1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.
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:
1. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR
2. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
6. 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.
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
8. 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.
9. Individuals with:
1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
435 participants
