Phase
Condition
Sjogren's Syndrome
Dermatomyositis (Connective Tissue Disease)
Treatment
Dazodalibep
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
MVZ Rheuma
Hamburg, 20095
GermanyActive - Recruiting
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona 85297-7336
United StatesActive - Recruiting
Bradenton Research Center Inc
Bradenton, Florida 34205-1704
United StatesActive - Recruiting
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida 33765-2616
United StatesActive - Recruiting
Shores Rheumatology
Saint Clair Shores, Michigan 48081-1274
United StatesActive - Recruiting
Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees, New Jersey 08043-4501
United StatesActive - Recruiting
R & H Clinical Research-777 S Fry Rd
Katy, Texas 77450-2297
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.