A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Last updated: May 21, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Treatment

Dazodalibep

Clinical Study ID

NCT06747949
HZNP-DAZ-304
2024-517513-32-00
20230050
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

  • Participant has provided informed consent before initiation of any study specificactivities/procedures.

  • Must have been eligible to receive and have received IP (dazodalibep or placebo) andcompleted the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).

  • Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) forthe prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Clinically significant active infection at Day 1, in the opinion of theInvestigator, including ongoing and chronic infection requiring antibiotics orantiviral medication.

  • Planned participation in another clinical study with an IP or procedure during theLTE study. Other investigational procedures and participation in observationalresearch studies while participating in this study are excluded.

  • Any condition or change in health status observed or reported during the phase 3 SSstudies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator orthe Sponsor, would interfere with evaluation and interpretation of participantsafety or alter the risk-benefit associated with IP administration, includinglaboratory studies performed on Week 44 of prior phase 3 study.

  • Planned surgeries or hospitalizations that, in the opinion of the Investigator orthe Sponsor, would interfere with evaluation and interpretation of participantsafety.

  • Individuals who plan to receive live (attenuated) vaccine during the LTE study.

  • Female participants of childbearing potential unwilling to use protocol-specifiedmethod of contraception during treatment and for an additional 12 weeks after thelast dose of investigational product.

  • Female participants who are pregnant or lactating or planning to become pregnantduring the study.

  • Male participants with a female partner of childbearing potential who are unwillingto practice sexual abstinence (refrain from heterosexual intercourse) or usecontraception during treatment and for an additional 12 weeks after the last dose ofinvestigational product.

  • Male participants with a pregnant partner or planning to become pregnant during thestudy.

  • Participant has known sensitivity to any of the products or components to beadministered during dosing.

  • Participant likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures to thebest of the participant and investigator's knowledge.

  • History or evidence of any other clinically significant disorder, condition, ordisease 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

Study Design

Total Participants: 844
Treatment Group(s): 1
Primary Treatment: Dazodalibep
Phase: 3
Study Start date:
February 25, 2025
Estimated Completion Date:
August 26, 2029

Connect with a study center

  • MVZ Rheuma

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St

    Gilbert, Arizona 85297-7336
    United States

    Active - Recruiting

  • Bradenton Research Center Inc

    Bradenton, Florida 34205-1704
    United States

    Active - Recruiting

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida 33765-2616
    United States

    Active - Recruiting

  • Shores Rheumatology

    Saint Clair Shores, Michigan 48081-1274
    United States

    Active - Recruiting

  • Arthritis, Rheumatic & Bone Disease Associates - P

    Voorhees, New Jersey 08043-4501
    United States

    Active - Recruiting

  • R & H Clinical Research-777 S Fry Rd

    Katy, Texas 77450-2297
    United States

    Active - Recruiting

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