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

• ClinicalTrials.gov Identifier: NCT06245408
• Recruitment Status: Recruiting
• First Posted: February 7, 2024
• Last Update Posted: April 29, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sjögren's Syndrome (SS)	Drug: Dazodalibep; Drug: Placebo	Phase 3

Detailed Description:

Acquired from Horizon in 2024.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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 (HZNP-DAZ-303)
• Actual Study Start Date: March 11, 2024
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: May 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dazodalibep Dose 1; Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.	Drug: Dazodalibep; IV infusion; Other Names: VIB 4920; MEDI4920
Experimental: Dazodalibep Dose 2; Participants will be administered dose 2 of dazodalibep by IV infusion.	Drug: Dazodalibep; IV infusion; Other Names: VIB 4920; MEDI4920
Placebo Comparator: Placebo; Participants will be administered placebo by IV infusion.	Drug: Placebo; IV infusion

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in ESSPRI score [ Time Frame: At Week 48 ]
2. Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score [ Time Frame: At week 48 ]

Secondary Outcome Measures :

1. Proportion of participants achieving meaningful improvement in DASPRI [ Time Frame: At Week 48 ]
2. Proportion of participants achieving ESSPRI [1.5] response [ Time Frame: At Week 48 ]
3. Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a) [ Time Frame: At Week 48 ]
4. Change from baseline in DASPRI Dryness [ Time Frame: At Week 48 ]
5. Change from baseline in ESSPRI Dryness [ Time Frame: At Week 48 ]
6. Change from baseline in DASPRI Pain [ Time Frame: At Week 48 ]
7. Change from baseline in ESSPRI Pain [ Time Frame: At Week 48 ]
8. Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score [ Time Frame: At Week 48 ]
9. Change from baseline in DASPRI total score [ Time Frame: At week 12 and week 24 ]
10. Change from baseline in ESSPRI total score [ Time Frame: At week 12, Week 24 ]
11. Change from baseline in DASPRI Fatigue [ Time Frame: At Week 48 ]
12. Change from baseline in ESSPRI fatigue domain score [ Time Frame: At Week 48 ]
13. Change from baseline in total stimulated salivary flow [ Time Frame: At Week 48 ]
14. Number of participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline (Day 1) to Week 56 ]
15. Number of participants With Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Baseline (Day 1) to Week 56 ]
16. Number of participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline (Day 1) to Week 56 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

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.

Contacts and Locations

Contacts

Contact: Amgen Call Center; 866-572-6436; medinfo@amgen.com

Locations

United States, Colorado

Denver Arthritis Clinic; Recruiting

Denver, Colorado, United States, 80230-7360

Contact: Kayla Rojas 303-394-2828 ext x177 krojas@dacdenver.com

Principal Investigator: Christopher Antolini

United States, Florida

Bradenton Research Center Inc; Recruiting

Bradenton, Florida, United States, 34205-1704

Contact: Gloria Carlbert 941-708-0005 gloriacarlbert@bradentonresearch.com

Principal Investigator: Eric Folkens

United States, Michigan

Shores Rheumatology; Recruiting

Saint Clair Shores, Michigan, United States, 48081-1274

Contact: Danielle Dickey 586-598-3329 ddickey@researchmi.com

Principal Investigator: Amar Majjhoo

United States, New Jersey

Arthritis, Rheumatic & Bone Disease Associates - P; Recruiting

Voorhees, New Jersey, United States, 08043-4509

Contact: Jessica Reibel 856-424-5005 ext x1179 jreibel@arbda.com

Principal Investigator: Ruchika Patel

United States, Texas

Amarillo Center For Clinical Research - ClinEdge - PPDS; Recruiting

Amarillo, Texas, United States, 79124-1601

Contact: Alina Noynouapheng 806-352-2453 anoynouanpheng@allergyarts.com

Principal Investigator: Constantine Saadeh

DM Clinical Research - ERN - PPDS; Recruiting

Tomball, Texas, United States, 77375-6543

Contact: Bylinda Vo-Le 281-517-0550 bylinda.vo-le@dmclinical.com

Principal Investigator: Shaikh Ali

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT06245408
• Other Study ID Numbers: HZNP-DAZ-303
• First Posted: February 7, 2024
• Last Update Posted: April 29, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• URL: http://www.amgen.com/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:

European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI); European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI); European Alliance of Associations for Rheumatology (EULAR)

Additional relevant MeSH terms:

Sjogren's Syndrome; Syndrome; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases