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

Launched by AMGEN · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dazodalibep to see how safe it is for people with Sjögren's Syndrome when taken over a longer period of time. Sjögren's Syndrome is an autoimmune condition that can cause dryness in the mouth and eyes, among other symptoms. The study is currently looking for participants who have previously taken dazodalibep or a placebo (a non-active treatment) in earlier studies and have completed those studies. To join, participants must give their consent and be able to start the treatment within a specific timeframe after their last visit in the previous studies.

Eligible participants should be aged between 65 and 74, and both men and women can join. However, those who have active infections, planned surgeries, or are pregnant or planning to become pregnant are not eligible. Participants can expect to receive the study treatment and will need to attend regular visits for safety checks and evaluations. This is a great opportunity for individuals who are looking to contribute to research that may help improve treatment options for Sjögren's Syndrome.

Gender

ALL

Eligibility criteria

• 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 specific activities/procedures.
• • 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).
• • Must 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).
• 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 the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
• • 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.
• • 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.
• • Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
• • Individuals who plan to receive live (attenuated) vaccine during the LTE study.
• • Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
• • Female participants who are pregnant or lactating or planning to become pregnant during the study.
• • 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.
• • Male participants with a pregnant partner or planning to become pregnant during the study.
• • Participant has known sensitivity to any of the products or components to be administered during dosing.
• • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
• • History or evidence of any other clinically significant disorder, condition, or disease 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