Purpose

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

Condition

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

ArmDescriptionAssigned 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.
  • Drug: Dazodalibep
    Dazodalibep will be given intravenously (IV).
    Other names:
    • AMG 611

Recruiting Locations

Arizona Arthritis & Rheumatology Associates - Avondale
Avondale 5552301, Arizona 5551752 85392

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff 5294810, Arizona 5551752 86001-6269

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert 5295903, Arizona 5551752 85297-7336

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale 5295985, Arizona 5551752 85306-9800

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson 5318313, Arizona 5551752 85704-1139

Samy Metyas MD Inc
Covina 5340175, California 5332921 91723

UCSD Altman Clinical and Translational Research Institute Building
La Jolla 5363943, California 5332921 92037-1337

Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins 5577147, Colorado 5417618 80528-3400

Bradenton Research Center Inc
Bradenton 4148708, Florida 4155751 34205-1704

Clinical Research of West Florida Inc - Clearwater
Clearwater 4151316, Florida 4155751 33765-2616

BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa 4174757, Florida 4155751 33614-7101

Tufts University School of Dental Medicine
Boston 4930956, Massachusetts 6254926 02111-1527

Shores Rheumatology
Saint Clair Shores 5010978, Michigan 5001836 48081-1274

Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City 4393217, Missouri 4398678 64151

Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees Township 5105860, New Jersey 5101760 08043-4501

Duke Early Phase Clinical Research Unit - PPDS
Durham 4464368, North Carolina 4482348 27710-0001

Onsite Clinical Solutions, LLC - Salisbury
Salisbury 4489985, North Carolina 4482348 28144

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg 4518188, Ohio 5165418 45342-3585

University of Toledo Medical Center
Toledo 5174035, Ohio 5165418 43614-2595

STAT Research-600 Aviator Ct
Vandalia 4527124, Ohio 5165418 45377-9474

Accurate Clinical Management-Baytown
Baytown 4672731, Texas 4736286 77521-2279

Precision Comprehensive Clinical Research Solutions
Colleyville 4682478, Texas 4736286 76034-5913

R & H Clinical Research-777 S Fry Rd
Katy 4702732, Texas 4736286 77450-2297

Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
Katy 4702732, Texas 4736286 77494-1341

Biopharma Informatic - Ridge Road - PPDS
McAllen 4709796, Texas 4736286 78503-1527

Advanced Rheumatology of Houston
The Woodlands 4736476, Texas 4736286 77382-2935

DM Clinical Research - Migraine and COPD - PPDS
Tomball 4737094, Texas 4736286 77375

Western Washington Medical Group, Bothell - Rheumatology
Bothell 5787829, Washington 5815135 98021

Rheumatology and Pulmonary Clinic
Beckley 4798308, West Virginia 4826850 25801-2805

More Details

NCT ID
NCT06747949
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.