Befejeződött3. fázis
An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
A legfontosabb adatok
- Ki végzi
- Viridian Therapeutics, Inc.
- Hol
- Burlington, East Weymouth, Houston, Las Vegas, Livonia, Los Angeles, Miami, Newark, Newport Beach, Oak Lawn, Palo Alto, Philadelphia, San Diego, Sarasota, Seattle és Somerset (Egyesült Államok)Mind a 18 helyszín megnézéseMég 7 másik országban, 27 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 139 fő vett részt
- Kezdés
- 2024. jan. 31.
- Befejezés
- 2025. jún. 23.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Veligrotug
- A regiszteradat frissítve
- 2026. augusztus 14.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
- Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
- Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
- Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative urine pregnancy test at screening
- Be willing and able to comply with all the requirements of the protocol for the entire duration of the study
Ki nem vehet részt
- Have received prior treatment with another anti-IGF-1R agent
- Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
- Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
- Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
- Have abnormal hearing test before first dose. Have a history of ear conditions considered significant by study doctor
- Participants must not:
Helyszínek itt: Egyesült Államok
Még 7 másik országban, 27 helyszínen
- University of Vermont Medical CenterBurlington, Egyesült ÁllamokNo longer taking part
- Ophthalmic Consultants of BostonEast Weymouth, Egyesült ÁllamokNo longer taking part
- Baylor College of MedicineHouston, Egyesült ÁllamokNo longer taking part
- Neuro-Eye Clinical TrialsHouston, Egyesült ÁllamokNo longer taking part
- Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic SurgeryLas Vegas, Egyesült ÁllamokNo longer taking part
- Kahana Oculoplastic & Orbital SurgeryLivonia, Egyesült ÁllamokNo longer taking part
- Advancing Research International, LLCLos Angeles, Egyesült ÁllamokNo longer taking part
- USC Eye InstituteLos Angeles, Egyesült ÁllamokNo longer taking part
- University of Miami, Miller School of Medicine, Bascom Palmer Eye InstituteMiami, Egyesült ÁllamokNo longer taking part
- Rutgers New Jersey Medical SchoolNewark, Egyesült ÁllamokNo longer taking part
- Advancing Research International, LLCNewport Beach, Egyesült ÁllamokNo longer taking part
- Vision Medical ResearchOak Lawn, Egyesült ÁllamokNo longer taking part
- Stanford Byers Eye InstitutePalo Alto, Egyesült ÁllamokNo longer taking part
- Hospital of the University of Pennsylvania Perleman CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- Cockerham Eye Consultants, PCSan Diego, Egyesült ÁllamokNo longer taking part
- Sarasota Retina InstituteSarasota, Egyesült ÁllamokNo longer taking part
- University of Washington Medical CenterSeattle, Egyesült ÁllamokNo longer taking part
- The Center for Eye and Facial Plastic SurgerySomerset, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.
A vizsgálat 2 csoportja
- Veligrotug/VeligrotugA vizsgált kezelés
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 milligrams (mg)/kilogram (kg) every 3 weeks (Q3W) for 12 weeks.
Kezelés: Veligrotug
- Placebo/VeligrotugA vizsgált kezelés
Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 mg/kg Q3W for 12 weeks.
Kezelés: Veligrotug
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies
- A regiszteradat frissítve
- 2026. augusztus 14.