A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
ConditionSjögren's Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen
About this trial
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
Trial design
Design model
Single group
Treatments tested in this trial
Dazodalibep
DrugDazodalibep will be given intravenously (IV).
Treatment groups
844 Participants
are divided into 1 treatment groupGroup A: DazodalibepExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
Time frame
Up to 152 weeksSecondary outcomes
1
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Time frame
Up to 132 weeks2
Plasma Concentration of Dazodalibep
Time frame
Up to 132 weeks Source ClinicalTrials.gov