A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Purpose

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.

Condition

  • Primary Sjogrens Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. - Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion Criteria

  • Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy - Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening. - Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion. - Use of cyclophosphamide ≤ 24 weeks prior to screening - Anti-CD20 or anti-CD19 antibody received < 6 months before screening

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Double-blinded treatment period: Efgartigimod PH20 SC 		Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
  • Biological: Efgartigimod PH20 SC
    subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo Comparator
Double-blinded treatment period: Placebo PH20 SC 		Participants receiving placebo PH20 SC during the double-blinded treatment period
  • Other: Placebo PH20 SC
    subcutaneous placebo PH20 SC given by prefilled syringe
Experimental
Open-label treatment period 		Participants receiving efgartigimod PH20 SC during the open-label treatment period
  • Biological: Efgartigimod PH20 SC
    subcutaneous efgartigimod PH20 SC given by prefilled syringe

Recruiting Locations

One of a Kind Clinical Research Center LLC
Scottsdale 5313457, Arizona 5551752 85258
Contact:
Anna Fehr
(480) 675-8982
anna@1-oak.net

Arizona Arthritis & Rheumatology Research, PLLC
Sun City 5316201, Arizona 5551752 85351
Contact:
Jenell Halvorson
(602) 386-4972
jenell.halvorson@azarthritis.com

Arizona Arthritis & Rheumatology Research, PLLC
Tucson 5318313, Arizona 5551752 85748
Contact:
Dawnavyn Shearer
(480) 626-6653
dawnavyn.shearer@aaracr.com

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835
Contact:
Lilia Ignacios
(714) 446-5950
lilia.ignacios@stjoe.org

Clinical Research of West Florida, Inc.
Clearwater 4151316, Florida 4155751 33765
Contact:
Sydney Mullen
804-477-3045
smullen@crwf.com

Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale 4155966, Florida 4155751 33309
Contact:
Arine Bagdasarian
(954) 229-0425
a.bagdasarian@aara.care

Finlay Medical Research Corp
Greenacres City 4157467, Florida 4155751 33647
Contact:
Arleny Martinez Vazquez
amartinez@finlaymr.com
amartinez@finlaymr.com

Life Clinical Trials
Margate 4163407, Florida 4155751 33063
Contact:
Ana Auza
(954) 669-1052
aauza@lctresearch.com

Clinical Research of West Florida, Inc.
Tampa 4174757, Florida 4155751 33606

Conquest Research
Winter Park 4178560, Florida 4155751 32789
Contact:
Sandy Pate
(407) 916-0060
sandy.pate@conquestresearch.com

Piedmont Healthcare, Inc.
Atlanta 4180439, Georgia 4197000 30318
Contact:
Kimberly Pruitt
(404) 367-3362
kimberly.pruitt@piedmont.org

St. Luke's Clinic - Rheumatology
Boise 5586437, Idaho 5596512 83702
Contact:
Jessica Grunke
(208) 489-4350
grunkej@slhs.org

Chicago Clinical Research Institute
Chicago 4887398, Illinois 4896861 60607
Contact:
Dennis Levinson, MD
312-791-3241
levinson@ccrii.us

Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago 4887398, Illinois 4896861 60640
Contact:
Mahmud Abdurrahman
(773) 275-3500
mabdurrahman@flourishresearch.com

Greater Chicago Specialty Physicians LLC
Orland Park 4904937, Illinois 4896861 60467
Contact:
Jason Tlais
(847) 599-2492
jtlais@cisresearch.com

Arizona Arthritis & Rheumatology Research, PLLC
Willowbrook 4916709, Illinois 4896861 60527
Contact:
Hiba Khan
(630) 794-8649
hkhan@willowrheum.com

Accurate Clinical Research Inc.
Lake Charles 4330236, Louisiana 4331987 70605
Contact:
Jacob Seep
337-312-8617
jseep@accurateclinicalresearch.com

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Jennifer Bruns
(314) 747-5366
brunsj@wustl.edu

Samaritan Health Services
Corvallis 5720727, Oregon 5744337 97330
Contact:
Kristen Moylan
(541) 768-5715
kmoylan@samhealth.org

East Penn Rheumatology Associates, P.C.
Bethlehem 5180225, Pennsylvania 6254927 18105
Contact:
Nicole Mihalek
(610) 868-1336
nmihalek@eastpenn-rheumatology.com

Allen Arthritis
Allen 4670300, Texas 4736286 75013

Accurate Clinical Management
Baytown 4672731, Texas 4736286 77521
Contact:
Mariela Martinez
281-422-7179
mmartinez@accurateclinicalresearch.com

Novel Research LLC
Bellaire 4673353, Texas 4736286 77401

Precision Comprehensive Clinical Research Solution
Colleyville 4682478, Texas 4736286 76034-5913
Contact:
Mohammad Sohail
(405) 608-1155
mohammadsohail@pccrsolutions.com

Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286 75235
Contact:
Ashreen Ghalib
(469) 893-1242
ashreen@swmedicalgroup.com

Arizona Arthritis & Rheumatology Research, PLLC
Fort Worth 4691930, Texas 4736286 76109

Accurate Clinical Research, Inc.
Houston 4699066, Texas 4736286 77089
Contact:
Phillip Waller, MD
281-240-1045
pwallermd@accurateclinicalresearch.com

North Houston Arthritis Center
Houston 4699066, Texas 4736286 77090
Contact:
Cecilia Valerio
(713) 797-6000
cvalerio@introscienceresearch.net

Arizona Arthritis & Rheumatology Research, PLLC
Irving 4700168, Texas 4736286 75039

R and H Clinical Research
Katy 4702732, Texas 4736286 77450

Simcare Medical Research LLC
Sugar Land 4734825, Texas 4736286 77478
Contact:
Nausheen Mujeeb
(832) 500-5186
admin@simcarepllc.com

Velocity Clinical Research Waco
Waco 4739526, Texas 4736286 76712
Contact:
Angelica Miller
(254) 294-4780
angelica@aara.care

More Details

NCT ID
NCT06684847
Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
857-350-4834
Clinicaltrials@argenx.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center