A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease

Status: Recruiting
Location: See all (72) locations...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks. An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The participant is at least 18 years of age

• The participant is capable of providing signed informed consent and following with protocol requirements

• The investigator determines active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions (Graves' disease or Hashimoto's thyroiditis) for the most severely affected eye

• The participant has first onset of active TED symptoms within 12 months before screening

• The participant must have normal thyroid function with the baseline disease under control or have mild hypo or hyperthyroidism at screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the normal thyroid function for the full duration of the study

• The participant agrees to use birth control consistent with local regulations and the people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug

Locations
United States
California
Thrive Health - Beverly Hills
RECRUITING
Beverly Hills
UCI Health - Gavin Herbert Eye Institute
RECRUITING
Irvine
University Of Southern California - Keck School Of Medicine
RECRUITING
Los Angeles
Silkiss Eye Surgery
RECRUITING
San Francisco
Florida
Advanced Research LLC
RECRUITING
Coral Springs
Levenson Eye Associates
RECRUITING
Jacksonville
Bascom Palmer Eye Institute
RECRUITING
Miami
University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
RECRUITING
Tampa
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Maryland
Wilmer Eye Institute
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbour
Missouri
Moyes Eye Center - Northland
RECRUITING
Kansas City
Quest Diagnostics - Mercy Smith Glynn Callaway
RECRUITING
Springfield
Pennsylvania
Penn Medicine - Penn Presbyterian Medical Center - Scheie Eye Institute
RECRUITING
Philadelphia
West Virginia
West Virginia University Eye Institute
RECRUITING
Morgantown
Other Locations
Australia
Centre for Eye Research Australia
RECRUITING
Melbourne
The University of Western Australia - Lions Eye Institute (LEI)
RECRUITING
Nedlands
North Shore Private Hospital
RECRUITING
St Leonards
Sydney Eye Hospital
RECRUITING
Sydney
Belgium
CHU UVC Brugmann - Site Victor Horta
RECRUITING
Brussels
Bulgaria
Oxycom Medical Centre
RECRUITING
Burgas
UMHAT Aleksandrovska - Diagnostic Consultative Center (DCC) Aleksandrova
RECRUITING
Sofia
Medical Center Vereya EOOD - Vereya Medical Center (former Military Hospital)
RECRUITING
Stara Zagora
St. Petka Eye Hospital - Eye Clinic St. Petka Varna
RECRUITING
Varna
China
Peking Union Medical College Hospital - Dongdan campus
RECRUITING
Beijing
Shunde Hospital of Southern Medical University
RECRUITING
Foshan
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Shanghai Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
Estonia
Dr Liina Viitas Endokrinoloog
RECRUITING
Pärnu
Tartu Ulikooli Kliinikum
RECRUITING
Tartu
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
RECRUITING
Berlin
Buergerhospital Frankfurt am Main
RECRUITING
Frankfurt
Universitaetsklinikum der Ernst-Moritz-Arndt-Universitaet Greifswald
RECRUITING
Greifswald
Universitaetsklinikum Muenster
RECRUITING
Münster
Greece
General Hospital of Athens G Gennimatas
RECRUITING
Athens
University General Hospital of Patras
RECRUITING
Pátrai
A.LOUKAS General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Athens Medical Group - European Interbalkan Medical Center
RECRUITING
Thessaloniki
Hungary
Budapest Retina Intezet
RECRUITING
Budapest
Vadnay Szemeszet es Latszereszet
RECRUITING
Eger
Ganglion Orvosi Kozpont
RECRUITING
Pécs
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) University of Pecs Medical School
RECRUITING
Pécs
Markusovszky Teaching Hospital
RECRUITING
Szombathely
Italy
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
Ospedale Policlinico San Martino
RECRUITING
Genova
ASST Santi Paolo e Carlo - Ospedale San Paolo
RECRUITING
Milan
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
RECRUITING
Milan
Azienda Ospedaliera Universitaria (AOU) Federico II
RECRUITING
Naples
Santa Chiara Hospital
RECRUITING
Pisa
ASST Sete Laghi - Ospedale di Circolo e Fondazione Macchi di Varese
RECRUITING
Varese
Romania
Centrul Medical Sana
RECRUITING
Bucharest
Institutul National de Endocrinologie C.I.Parhon
RECRUITING
Bucharest
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Sf. Spiridon
RECRUITING
Iași
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Clinico Universitario De Santiago De Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bang Phlat
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital
RECRUITING
Chiang Mai
Srinagarind Hospital
RECRUITING
Khon Kaen
United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
RECRUITING
Bradford
Cardiff and Vale University Health Board - University Hospital of wales (UHW)
RECRUITING
Cardiff
Frimley Health NHS Foundation Trust - Frimley Park Hospital
RECRUITING
Frimley
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2027-09
Participants
Target number of participants: 123
Treatments
Experimental: Efgartigimod arm
Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Placebo_comparator: Placebo arm
Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov

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