Clinical Trials List
Protocol Number20230050 (HZNP-DAZ-304)
NCT Number(ClinicalTrials.gov Identfier)NCT06747949
Active
2025-09-01 - 2029-12-31
Phase III
Recruiting5
ICD-10M35.00
Sicca syndrome, unspecified
ICD-10M35.01
Sicca syndrome with keratoconjunctivitis
ICD-10M35.09
Sicca syndrome with other organ involvement
ICD-9710.2
Sicca syndrome
A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants with Sjögren’s Syndrome (SS)
-
Sponsor
Amgen, Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 黃建中 風濕免疫科
- 張詩欣 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jeng-Hsien Yen 風濕免疫科
- Chia-Chun Tseng 風濕免疫科
- 歐燦騰 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chi-Ching Chang
Co-Principal Investigator
- 李向嚴 Division of Rheumatology
- Tzn-Min Lin
- 張克宇 Division of Rheumatology
- 林韋睿 Division of Rheumatology
- 林科宏
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張哲慈 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- Shue-Fen Lo Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Hsing Chen Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- 高宗楙 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- 顏在弘 Division of Rheumatology
- 林靖才 Division of Rheumatology
- 陳彥如 Division of Rheumatology
- 謝祖怡
- Yi-Ming Chen Division of Rheumatology
- 廖育婉
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Sjögren’s Syndrome (SS)
Objectives
To evaluate the long-term safety and
tolerability of dazodalibep.
Test Drug
Injection
Active Ingredient
Dazodalibep
Dosage Form
270
Dosage
1500 mg/ 15 ml
Endpoints
Incidence of treatment-emergent
adverse events (TEAEs), treatment-
emergent serious adverse events
(TESAEs), and adverse events of
special interest (AESIs).
adverse events (TEAEs), treatment-
emergent serious adverse events
(TESAEs), and adverse events of
special interest (AESIs).
Inclution Criteria
Participants are eligible to be included in the study only if all the following criteria apply:
101 Participant has provided informed consent before initiation of any study-specific
activities/procedures.
102 Must have been eligible to receive and have received IP (dazodalibep or
placebo) and completed the study (through Week 48) in one of the phase 3 SS
dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
Note: Participants who prematurely discontinued IP are not eligible for this study.
103 Be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for
the prior pivotal phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-
DAZ-303).
Note: Participants may be enrolled after Week 48 Visit (+28 days) upon Amgen
medical monitor approval.
101 Participant has provided informed consent before initiation of any study-specific
activities/procedures.
102 Must have been eligible to receive and have received IP (dazodalibep or
placebo) and completed the study (through Week 48) in one of the phase 3 SS
dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
Note: Participants who prematurely discontinued IP are not eligible for this study.
103 Be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for
the prior pivotal phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-
DAZ-303).
Note: Participants may be enrolled after Week 48 Visit (+28 days) upon Amgen
medical monitor approval.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Other Medical Conditions
201 Clinically significant active infection at Day 1, in the opinion of the Investigator,
including ongoing and chronic infection requiring antibiotics or antiviral
medication.
Prior/Concurrent Clinical Study Experience
202 Planned participation in another clinical study with an IP or procedure during the
LTE study. Other investigational procedures and participation in observational
research studies while participating in this study are excluded.
Other Exclusions
203 Any condition or change in health status observed or reported during the phase 3
SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the
Investigator or the Sponsor, would interfere with evaluation and interpretation of
participant safety or alter the risk-benefit associated with IP administration,
including laboratory studies performed on Week 44 of prior phase 3 study.
204 Planned surgeries or hospitalizations that, in the opinion of the Investigator or the
Sponsor, would interfere with evaluation and interpretation of participant safety.
205 Individuals who plan to receive live (attenuated) vaccine during the LTE study.
206 Female participants of childbearing potential unwilling to use protocol-specified
method of contraception see (Section 11.5) during treatment and for an
additional 12 weeks after the last dose of investigational product.
207 Female participants who are breastfeeding or who plan to breastfeed while on
study through 12 weeks after the last dose of investigational product.
208 Female participants planning to become pregnant or donate eggs while on study
through 12 weeks after the last dose of investigational product.
209 Female participants of childbearing potential with a positive pregnancy test
assessed at day 1 by a highly sensitive urine pregnancy test.
210 Male participants with a female partner of childbearing potential who are unwilling
to practice sexual abstinence (refrain from heterosexual intercourse) or use
contraception during treatment and for an additional 12 weeks after the last dose
of investigational product. Refer to Section 11.5 for additional contraceptive
information.
211 Male participants with a pregnant partner who are unwilling to practice
abstinence or use a condom during treatment and for an additional 12 weeks
after the last dose of investigational product.
212 Male participants unwilling to abstain from donating sperm during treatment and
for an additional 12 weeks after the last dose of investigational product.
213 Participant has known sensitivity to any of the products or components to be
administered during dosing.
214 Participant likely to not be available to complete all protocol-required study visits
or procedures, and/or to comply with all required study procedures (eg, Clinical
Outcome Assessments) to the best of the participant and investigator’s
knowledge.
215 History or evidence of any other clinically significant disorder, condition, or
disease (except for those outlined above) that, in the opinion of the investigator
or Amgen physician, if consulted, would pose a risk to participant safety or
interfere with the study evaluation, procedures or completion.
Other Medical Conditions
201 Clinically significant active infection at Day 1, in the opinion of the Investigator,
including ongoing and chronic infection requiring antibiotics or antiviral
medication.
Prior/Concurrent Clinical Study Experience
202 Planned participation in another clinical study with an IP or procedure during the
LTE study. Other investigational procedures and participation in observational
research studies while participating in this study are excluded.
Other Exclusions
203 Any condition or change in health status observed or reported during the phase 3
SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the
Investigator or the Sponsor, would interfere with evaluation and interpretation of
participant safety or alter the risk-benefit associated with IP administration,
including laboratory studies performed on Week 44 of prior phase 3 study.
204 Planned surgeries or hospitalizations that, in the opinion of the Investigator or the
Sponsor, would interfere with evaluation and interpretation of participant safety.
205 Individuals who plan to receive live (attenuated) vaccine during the LTE study.
206 Female participants of childbearing potential unwilling to use protocol-specified
method of contraception see (Section 11.5) during treatment and for an
additional 12 weeks after the last dose of investigational product.
207 Female participants who are breastfeeding or who plan to breastfeed while on
study through 12 weeks after the last dose of investigational product.
208 Female participants planning to become pregnant or donate eggs while on study
through 12 weeks after the last dose of investigational product.
209 Female participants of childbearing potential with a positive pregnancy test
assessed at day 1 by a highly sensitive urine pregnancy test.
210 Male participants with a female partner of childbearing potential who are unwilling
to practice sexual abstinence (refrain from heterosexual intercourse) or use
contraception during treatment and for an additional 12 weeks after the last dose
of investigational product. Refer to Section 11.5 for additional contraceptive
information.
211 Male participants with a pregnant partner who are unwilling to practice
abstinence or use a condom during treatment and for an additional 12 weeks
after the last dose of investigational product.
212 Male participants unwilling to abstain from donating sperm during treatment and
for an additional 12 weeks after the last dose of investigational product.
213 Participant has known sensitivity to any of the products or components to be
administered during dosing.
214 Participant likely to not be available to complete all protocol-required study visits
or procedures, and/or to comply with all required study procedures (eg, Clinical
Outcome Assessments) to the best of the participant and investigator’s
knowledge.
215 History or evidence of any other clinically significant disorder, condition, or
disease (except for those outlined above) that, in the opinion of the investigator
or Amgen physician, if consulted, would pose a risk to participant safety or
interfere with the study evaluation, procedures or completion.
The Estimated Number of Participants
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Taiwan
21 participants
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Global
844 participants
