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A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

PHASE3RECRUITING

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2.

To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS.

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Study details:

Acquired from Horizon in 2024.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria

Have an ESSPRI score of ≥ 5 at screening.

Have an ESSDAI score of < 5 at screening.

Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).

Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.

Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.

Meets all of the following tuberculosis (TB) criteria: No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment. No signs or symptoms suggestive of active TB from medical history or physical examination. 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). 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. 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

Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.

History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.

Active malignancy or history of malignancy within the last 5 years, except as follows: In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR Cutaneous basal cell carcinoma following presumed curative therapy.

Individuals who are pregnant or lactating or planning to become pregnant during the study.

Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.

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.

Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.

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.

Individuals with: 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. 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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-11

Primary completion: 2026-05-01

Study completion finish: 2026-05-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06245408

Intervention or treatment

DRUG: Dazodalibep

DRUG: Placebo

Conditions

• Sjögren's Syndrome (SS)

Image related to Sjögren's Syndrome (SS)

Condition: Sjögren's Syndrome (SS)
DRUG: Dazodalibep and other drugs
Woodville South, South Australia, Australia
Sponsor: Amgen

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Find a site

Closest Location:

The Queen Elizabeth Hospital

Research sites nearby

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The Queen Elizabeth Hospital
Woodville South, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dazodalibep Dose 1 Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.	DRUG: Dazodalibep IV infusion
EXPERIMENTAL: Dazodalibep Dose 2 Participants will be administered dose 2 of dazodalibep by IV infusion.	DRUG: Dazodalibep IV infusion
PLACEBO_COMPARATOR: Placebo Participants will be administered placebo by IV infusion.	DRUG: Placebo IV infusion

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline in ESSPRI score	Not Specified	At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score	Not Specified	At week 48

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of participants achieving meaningful improvement in DASPRI	Not Specified	At Week 48
Proportion of participants achieving ESSPRI [1.5] response	Not Specified	At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)	Not Specified	At Week 48
Change from baseline in DASPRI Dryness	Not Specified	At Week 48
Change from baseline in ESSPRI Dryness	Not Specified	At Week 48
Change from baseline in DASPRI Pain	Not Specified	At Week 48
Change from baseline in ESSPRI Pain	Not Specified	At Week 48
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score	Not Specified	At Week 48
Change from baseline in DASPRI total score	Not Specified	At week 12 and week 24
Change from baseline in ESSPRI total score	Not Specified	At week 12, Week 24
Change from baseline in DASPRI Fatigue	Not Specified	At Week 48
Change from baseline in ESSPRI fatigue domain score	Not Specified	At Week 48
Change from baseline in total stimulated salivary flow	Not Specified	At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)	Not Specified	Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)	Not Specified	Baseline (Day 1) to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)	Not Specified	Baseline (Day 1) to Week 56

Frequently Asked Questions

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References

Clinical Trials Gov: A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State