Clinical trial NCT06684847: A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Official title: A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Sjogrens Disease
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion Criteria:

* Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis.
* 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 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

Primary outcomes:
measure: Change from baseline in clinESSDAI score at week 48
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Change from baseline in ESSDAI score at week 48
timeFrame: Up to 48 weeks
measure: Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
timeFrame: Up to 48 weeks
measure: Proportion of responders on STAR (defined as ≥ 5 points) at week 48
timeFrame: Up to 48 weeks
measure: Change from baseline in DiSSA joint pain item at week 48
timeFrame: Up to 48 weeks
measure: Change from baseline in DiSSA total score at week 48
timeFrame: Up to 48 weeks
measure: Change from baseline in DiSSA sicca domain at week 48
timeFrame: Up to 48 weeks
measure: Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
timeFrame: Up to 48 weeks
measure: Change from baseline in clinESSDAI score at week 24
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Greenacres
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Boise
country: United States
facility: St. Luke's Clinic - Rheumatology
state: Idaho
city: Chicago
country: United States
facility: Chicago Clinical Research Institute
state: Illinois
city: Willowbrook
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research Inc.
state: Louisiana
city: Corvallis
country: United States
facility: Samaritan Health Services
state: Oregon
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, P.C.
state: Pennsylvania
city: Allen
country: United States
facility: Allen Arthritis
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management
state: Texas
city: Bellaire
country: United States
facility: Novel Research LLC
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solution
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Fort Worth
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: North Houston Arthritis Center
state: Texas
city: Irving
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Texas
city: Katy
country: United States
facility: R and H Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research LLC
state: Texas
city: Waco
country: United States
facility: Velocity Clinical Research Waco
state: Texas
city: Wien
country: Austria
facility: Rheuma-Zentrum Wien Oberlaa
city: Bruxelles
country: Belgium
facility: Erasme Hospital
city: Genk
country: Belgium
facility: ReumaClinic
city: Gent
country: Belgium
facility: UZ Gent
city: Plovdiv
country: Bulgaria
facility: MC Artmed OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Pulmed" OOD
city: Sliven
country: Bulgaria
facility: MHAT Dr Ivan Seliminski AD
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska" EOOD
city: Montreal
country: Canada
facility: Applied Medical Informatics Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: G.R.M.O Groupe De Recherche En Maladie Osseuses Inc
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tartu
country: Estonia
facility: Meditrials
city: Marseille
country: France
facility: Hôpital Saint Joseph
state: Bouches-du-Rhône
city: Orléans Cedex 2
country: France
facility: CHR Orléans
state: Loiret
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Tbilisi
country: Georgia
facility: VIAN
city: Tbilisi
country: Georgia
facility: MediClub Georgia LLC
city: Tbilisi
country: Georgia
facility: Clinic on Mtskheta Street
city: Tbilisi
country: Georgia
facility: First Medical Center
city: Tbilisi
country: Georgia
facility: Innova LLC
city: Hamburg
country: Germany
facility: HRF II - Hamburger Rheuma Forschungszentrum II
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szekesfehervar
country: Hungary
facility: Vita Verum Medical
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima-Ken
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi-Ken
city: Sendai-shi
country: Japan
facility: Tohoku Medical and Pharmaceutical University Hospital
state: Miyagi-Ken
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka-Fu
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
state: Shizuoka-Ken
city: Meguro-ku
country: Japan
facility: NHO Tokyo Medical Center
state: Tokyo-To
city: Amman
country: Jordan
facility: The Specialty Hospital Advanced Clinical Center
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Amman
country: Jordan
facility: Abdali Hospital
city: Amman
country: Jordan
facility: Istiklal Hospital
city: Irbid
country: Jordan
facility: Pharmaceutical research center at Jordan University of Science and Technology
city: Irbid
country: Jordan
facility: Irbid Specialty Hospital
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital
city: Vilnius
country: Lithuania
facility: Inlita, JSC, Center of Santaros Clinical Trials
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor Sp. z o.o
city: Częstochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Grodzisk Mazowiecki
country: Poland
facility: MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Krakow
country: Poland
facility: FutureMeds Krakow
city: Lodz
country: Poland
facility: SOMED CR
city: Lodz
country: Poland
facility: FutureMeds
city: Lublin
country: Poland
facility: ETG Lublin
city: Lublin
country: Poland
facility: Reumed Spolka z o.o.
city: Piotrkow Trybunalski
country: Poland
facility: Provita Profamilia
city: Poznan
country: Poland
facility: NSZOZ Termedica - Centrum Badan Klinicznych
city: Poznań
country: Poland
facility: Clinical Research Center Spółka z
city: Warsaw
country: Poland
facility: FutureMeds
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Izabela Inglot Szczebiot
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
city: Warszawa
country: Poland
facility: REUMA CENTRUM Specjalistyczna Praktyka Lekarska
city: Wroclaw
country: Poland
facility: FutureMeds
city: Brasov
country: Romania
facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
city: Bucuresti
country: Romania
facility: S.C Delta Health Care S.R.L
city: Constanta
country: Romania
facility: SC Aqua Med Consulting SRL
city: Kosice
country: Slovakia
facility: Artromac
city: Martin
country: Slovakia
facility: MEDMAN
city: Zvolen
country: Slovakia
facility: ALBAMED
city: Santiago de Compostela
country: Spain
facility: Clinica GAIAS Santiago
state: La Coruña
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Stockholm
country: Sweden
facility: Studieenheten
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital
Study officials:
References: