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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06747949
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Canada, Chile, France, Germany, Hungary, Israel, Japan, New Zealand, Poland, Portugal, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sjögren's Syndrome
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Dazodalibep/Dazodalibep

Participants who completed the 48-week dazodalibep treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will continue with their assigned dose (1 or 2) for an additional 144 weeks.

Experimental: Placebo/Dazodalibep

Participants who completed the 48-week placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will be randomized 1:1 to dazodalibep (dose 1 or 2) for an additional 144 weeks.

Interventions

Drug: - Dazodalibep

Dazodalibep will be given intravenously (IV).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gilbert 5295903, Arizona 5551752

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St

Gilbert 5295903, Arizona 5551752, 85297-7336

Glendale 5295985, Arizona 5551752

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln

Glendale 5295985, Arizona 5551752, 85306-9800

Bradenton Research Center Inc, Bradenton 4148708, Florida 4155751

Status

Recruiting

Address

Bradenton Research Center Inc

Bradenton 4148708, Florida 4155751, 34205-1704

Clearwater 4151316, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida Inc - Clearwater

Clearwater 4151316, Florida 4155751, 33765-2616

Tampa 4174757, Florida 4155751

Status

Recruiting

Address

BayCare Medical Group Primary Care and Rheumatology - Tampa

Tampa 4174757, Florida 4155751, 33614-7101

Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Tufts University School of Dental Medicine

Boston 4930956, Massachusetts 6254926, 02111-1527

Shores Rheumatology, Saint Clair Shores 5010978, Michigan 5001836

Status

Recruiting

Address

Shores Rheumatology

Saint Clair Shores 5010978, Michigan 5001836, 48081-1274

Kansas City 4393217, Missouri 4398678

Status

Recruiting

Address

Kansas City Physician Partners-8350 N Saint Clair Ave

Kansas City 4393217, Missouri 4398678, 64151

Voorhees Township 5105860, New Jersey 5101760

Status

Recruiting

Address

Arthritis, Rheumatic & Bone Disease Associates - P

Voorhees Township 5105860, New Jersey 5101760, 08043-4501

Miamisburg 4518188, Ohio 5165418

Status

Recruiting

Address

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

Miamisburg 4518188, Ohio 5165418, 45342-3585

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

Status

Recruiting

Address

STAT Research-600 Aviator Ct

Vandalia 4527124, Ohio 5165418, 45377-9474

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

Status

Recruiting

Address

R & H Clinical Research-777 S Fry Rd

Katy 4702732, Texas 4736286, 77450-2297

Katy 4702732, Texas 4736286

Status

Recruiting

Address

Houston Rheumatology & Arthritis Specialists - PLLC - PPDS

Katy 4702732, Texas 4736286, 77494-1341

Tomball 4737094, Texas 4736286

Status

Recruiting

Address

DM Clinical Research - Migraine and COPD - PPDS

Tomball 4737094, Texas 4736286, 77375

Bothell 5787829, Washington 5815135

Status

Recruiting

Address

Western Washington Medical Group, Bothell - Rheumatology

Bothell 5787829, Washington 5815135, 98021

Rheumatology and Pulmonary Clinic, Beckley 4798308, West Virginia 4826850

Status

Recruiting

Address

Rheumatology and Pulmonary Clinic

Beckley 4798308, West Virginia 4826850, 25801-2805

International Sites

Ciudad Autónoma de Buenos Aires, Buenos Aires 3435907, Argentina

Status

Recruiting

Address

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires 3435907, C1426ABP

DOM Centro de Reumatología, Buenos Aires 3435910, Ciudad Autónoma de BuenosAires, Argentina

Status

Recruiting

Address

DOM Centro de Reumatología

Buenos Aires 3435910, Ciudad Autónoma de BuenosAires, C1111

San Miguel de Tucumán 3836873, Tucumán Province 3833578, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia - PPDS

San Miguel de Tucumán 3836873, Tucumán Province 3833578, T4000AXL

Clínica Mayo de U.M.C.B. S.R.L, San Miguel de Tucumán 3836873, Tucumán Province 3833578, Argentina

Status

Recruiting

Address

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán 3836873, Tucumán Province 3833578, T4000IHE

Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Aprillus Asistencia e Investigacion - Terrada 89

Buenos Aires 3435910, , 1406

Framingham Centro Médico, La Plata 3432043, Argentina

Status

Recruiting

Address

Framingham Centro Médico

La Plata 3432043, , B1902COS

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán 3836873, Argentina

Status

Recruiting

Address

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán 3836873, , T4000AXL

Trois-Rivières 6169141, Quebec 6115047, Canada

Status

Recruiting

Address

Clinique de Rhumatologie Du Centre Du Quebec

Trois-Rivières 6169141, Quebec 6115047, G8Z 1Y2

Viña del Mar 3868121, Región de Valparaíso 3868621, Chile

Status

Recruiting

Address

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar 3868121, Región de Valparaíso 3868621, 2520000

Providencia 3875139, Chile

Status

Recruiting

Address

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia 3875139, , 7500000

CHU de Bordeaux - Hôpital Saint-André, Bordeaux 3031582, France

Status

Recruiting

Address

CHU de Bordeaux - Hôpital Saint-André

Bordeaux 3031582, , 33000

MVZ Rheuma, Hamburg 2911298, Germany

Status

Recruiting

Address

MVZ Rheuma

Hamburg 2911298, , 20095

Vasarhelyi Sarkanyfu Kft., Hódmezovásárhely, Csongrád megye 721589, Hungary

Status

Recruiting

Address

Vasarhelyi Sarkanyfu Kft.

Hódmezovásárhely, Csongrád megye 721589, 6800

Debrecen 721472, Hajdú-Bihar 720293, Hungary

Status

Recruiting

Address

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen 721472, Hajdú-Bihar 720293, 4032

Meir Medical Center, Kafr Saba 294514, Central District 294904, Israel

Status

Recruiting

Address

Meir Medical Center

Kafr Saba 294514, Central District 294904, 4428164

Chubu Rosai Hospital, Nagoya-shi, Akita 2113124, Japan

Status

Recruiting

Address

Chubu Rosai Hospital

Nagoya-shi, Akita 2113124, 455-0018

Kita Kyushu-shi, Hukuoka, Japan

Status

Recruiting

Address

Hospital of the University of Occupational and Environmental Health, Japan

Kita Kyushu-shi, Hukuoka, 807-8556

Kurashiki Medical Clinic, Kurashiki-Shi, Okayama-ken 1854381, Japan

Status

Recruiting

Address

Kurashiki Medical Clinic

Kurashiki-Shi, Okayama-ken 1854381, 710-0824

Saitama Medical University Hospital, Iruma-Gun Moroyama-Machi, Saitama 1853226, Japan

Status

Recruiting

Address

Saitama Medical University Hospital

Iruma-Gun Moroyama-Machi, Saitama 1853226, 350-0451

Hamamatsu University Hospital, Hamamatsu 1863289, Shizuoka 1851715, Japan

Status

Recruiting

Address

Hamamatsu University Hospital

Hamamatsu 1863289, Shizuoka 1851715, 431-3192

St. Luke's International Hospital, Chuo-Ku, Tokyo 1850144, Japan

Status

Recruiting

Address

St. Luke's International Hospital

Chuo-Ku, Tokyo 1850144, 104-0044

Waikato Hospital, Hamilton 2190324, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton 2190324, , 3240

Papatoetoe 6232008, New Zealand

Status

Recruiting

Address

Aotearoa Clinical Trials Trust- Middlemore Hospital

Papatoetoe 6232008, , 2025

Centrum Medyczne Oporow, Wroclaw 3081368, Lower Silesian Voivodeship 3337492, Poland

Status

Recruiting

Address

Centrum Medyczne Oporow

Wroclaw 3081368, Lower Silesian Voivodeship 3337492, 52-416

ETG Lublin - PPDS, Lublin 765876, Lublin Voivodeship 858785, Poland

Status

Recruiting

Address

ETG Lublin - PPDS

Lublin 765876, Lublin Voivodeship 858785, 20-412

Lublin 765876, Lublin Voivodeship 858785, Poland

Status

Recruiting

Address

Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

Lublin 765876, Lublin Voivodeship 858785, 20-607

Warsaw 756135, Masovian Voivodeship 858787, Poland

Status

Recruiting

Address

MICS Centrum Medyczne Warszawa - MICS - PPDS

Warsaw 756135, Masovian Voivodeship 858787, 00-874

ARS RHEUMATICA Sp. z o.o., Warsaw 756135, Masovian Voivodeship 858787, Poland

Status

Recruiting

Address

ARS RHEUMATICA Sp. z o.o.

Warsaw 756135, Masovian Voivodeship 858787, 02-665

Centrum Medyczne K2J2 - Wołomin, Wołomin 754800, Masovian Voivodeship 858787, Poland

Status

Recruiting

Address

Centrum Medyczne K2J2 - Wołomin

Wołomin 754800, Masovian Voivodeship 858787, 05-200

Malbork 3092472, Pomeranian Voivodeship 3337496, Poland

Status

Recruiting

Address

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

Malbork 3092472, Pomeranian Voivodeship 3337496, 82-200

MICS Centrum Medyczne Bydgoszcz, Bydgoszcz 3102014, Poland

Status

Recruiting

Address

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz 3102014, , 85-065

Bydgoszcz 3102014, Poland

Status

Recruiting

Address

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz 3102014, , 85-168

Katowice 3096472, Poland

Status

Recruiting

Address

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice 3096472, , 40-081

FutureMeds - Lodz - PPDS, Lodz 3093133, Poland

Status

Recruiting

Address

FutureMeds - Lodz - PPDS

Lodz 3093133, , 91-363

Twoja Przychodnia PCM, Poznan 3088171, Poland

Status

Recruiting

Address

Twoja Przychodnia PCM

Poznan 3088171, , 60-324

FutureMeds - Warszawa Centrum - PPDS, Warsaw 756135, Poland

Status

Recruiting

Address

FutureMeds - Warszawa Centrum - PPDS

Warsaw 756135, , 00-215

Wroclaw 3081368, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213

Wroclaw 3081368, , 50-556

Wroclaw 3081368, Poland

Status

Recruiting

Address

Pracownia Badan Klinicznych Salus - Jerzego Kukuczki 5

Wroclaw 3081368, , 50-570

FutureMeds - Wroclaw - PPDS, Wroclaw 3081368, Poland

Status

Recruiting

Address

FutureMeds - Wroclaw - PPDS

Wroclaw 3081368, , 53-673

Ponte de Lima 2736041, Portugal

Status

Recruiting

Address

Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima

Ponte de Lima 2736041, , 4990-150

ULS de Gaia/Espinho, EPE - Unidade I, Vila Nova de Gaia 2732544, Portugal

Status

Recruiting

Address

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia 2732544, , 4434-502