A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Purpose
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Condition
- Sjögren's Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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. - 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. - 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dazodalibep |
Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks. |
|
Recruiting Locations
Avondale, Arizona 85392
Flagstaff, Arizona 86001-6269
Gilbert, Arizona 85297-7336
Glendale, Arizona 85306-9800
Tucson, Arizona 85704-1139
Covina, California 91723
La Jolla, California 92037-1337
Fort Collins, Colorado 80528-3400
Bradenton, Florida 34205-1704
Clearwater, Florida 33765-2616
Tampa, Florida 33614-7101
Boston, Massachusetts 02111-1527
Saint Clair Shores, Michigan 48081-1274
Kansas City, Missouri 64151
Voorhees Township, New Jersey 08043-4501
Charlotte, North Carolina 28207-1100
Durham, North Carolina 27710-0001
Salisbury, North Carolina 28144
Miamisburg, Ohio 45342-3585
Toledo, Ohio 43614-2595
Vandalia, Ohio 45377-9474
Murfreesboro, Tennessee 37128
Baytown, Texas 77521-2279
Colleyville, Texas 76034-5913
Katy, Texas 77450-2297
Katy, Texas 77494-1341
McAllen, Texas 78503-1527
The Woodlands, Texas 77382-2935
Tomball, Texas 77375
Bothell, Washington 98021
Beckley, West Virginia 25801-2805
More Details
- Status
- Recruiting
- Sponsor
- Amgen