A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
SIENNA
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
2 other identifiers
interventional
975
10 countries
216
Brief Summary
This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug(s)
- How much study drug(s) are in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
Longer than P75 for phase_3
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 21, 2032
May 7, 2026
March 1, 2026
3.1 years
August 2, 2024
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)
To week 52
Secondary Outcomes (15)
Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline
At week 52 and week 104
Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA)
At week 52 and week 104
Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)
At week 52 and week 104
Change from baseline in quantitative Contrast Sensitivity Function (qCSF)
At week 52 and week 104
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF
To week 104
- +10 more secondary outcomes
Study Arms (3)
Pozelimab + Cemdisiran treatment group
EXPERIMENTALRandomized 1:1:1
Cemdisiran monotherapy treatment group
EXPERIMENTALRandomized 1:1:1
Placebo treatment group
PLACEBO COMPARATORRandomized 1:1:1
Interventions
Subcutaneous (SC) injection
SC injection
Eligibility Criteria
You may qualify if:
- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
- Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
- BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
- Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol
You may not qualify if:
- GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
- History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
- Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
- Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
- Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol
- History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
- History of solid organ or bone marrow transplantation
- Use of chronic (\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
- Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol
- Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
- Carrier of Neisseria meningitidis based on culture collected during screening
- Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (216)
Barnet Dulaney Perkins Eye Center-Ophthamalogy
Chandler, Arizona, 85224, United States
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016, United States
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Retinal Research Institute
Phoenix, Arizona, 85053, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255, United States
Retina Associates of Tuscan
Tucson, Arizona, 85712, United States
Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas, 72764, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Specialists of Beverly Hills- Department of Ophthalmology
Beverly Hills, California, 90212, United States
The Retina Partners
Encino, California, 91436, United States
Eye Medical Center of Fresno
Fresno, California, 93720, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Salehi Retina Institute dba Retina Associates of Southern California
Huntington Beach, California, 92647, United States
University of California Irvine
Irvine, California, 92617, United States
University of California San Diego, Jacobs Retina Center
La Jolla, California, 92093, United States
South Coast Retina Center
Long Beach, California, 90807, United States
American Institute of Research
Los Angeles, California, 90017, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Jules Stein Eye Institute in David Geffen School of Medicine at Ucla
Los Angeles, California, 90095, United States
Retinal Consultants Medical Group Inc Modesto
Modesto, California, 95356, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040, United States
California Retina Consultants
Oxnard, California, 93036, United States
Desert Retina Consultants
Palm Desert, California, 92211, United States
California Eye Specialists Medical Group Inc.
Pasadena, California, 91107, United States
Retina Consultants San Diego
Poway, California, 92064, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373, United States
Optic Eye Care
Rowland Heights, California, 91748, United States
UC Davis Health Eye Center
Sacramento, California, 95817, United States
Vrmg Inc
Sacramento, California, 95825, United States
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
Sacramento, California, 95841, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
Macula Retina Vitreous Research Institute
Torrance, California, 90503, United States
University of Colorado
Aurora, Colorado, 80045, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
Retina Specialists of Colorado - Denver
Denver, Colorado, 80222, United States
Southwest Retina Research Center
Durango, Colorado, 81303, United States
Colorado Retina - Lakewood
Lakewood, Colorado, 80228, United States
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
Longmont, Colorado, 80503, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Advanced Retina Institute-Ophthalmology
Bonita Springs, Florida, 34134, United States
Advanced Research
Coral Springs, Florida, 33067, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
ClearVista Clinical Research, Retina Center Tampa Bay
Hudson, Florida, 34667, United States
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
Jacksonville, Florida, 32216, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Bascom Palmer Eye Institute
Naples, Florida, 34103, United States
Florida Retina Institute - Orlando
Orlando, Florida, 32806, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
Sarasota, Florida, 34232, United States
Retina Vitreous Associates of Florida Saint Petersburg
St. Petersburg, Florida, 33711, United States
University of South Florida Ophthalmology
Tampa, Florida, 33612, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina - Marietta
Marietta, Georgia, 30060, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Retinal Vitreal Consultants
Chicago, Illinois, 60616, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University Retina and Macula Associates PC - Lemont
Lemont, Illinois, 60439, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Springfield Clinic Main Campus East
Springfield, Illinois, 62703, United States
Retina Associates, LLC
Lenexa, Kansas, 66215, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Retina Associates New Orleans
Metairie, Louisiana, 70006, United States
Ross Davis Retina
Metairie, Louisiana, 70006, United States
Ochsner Health
New Orleans, Louisiana, 70121, United States
Eye Assoc. of NE LA dba Haik Humble Eye Ctr
West Monroe, Louisiana, 71291, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana, 71291, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants-Ophthalmology
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, 21740, United States
Massachusetts Eye And Ear Infirmary
Boston, Massachusetts, 02114, United States
Opthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
New England Retina Consultants, PC
Springfield, Massachusetts, 01107, United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, 38671, United States
Retina Research Institute, LLC
St Louis, Missouri, 63144, United States
Mid Atlantic Retina - Cherry Hill
Cherry Hill, New Jersey, 08034, United States
New Jersey Retina
Teaneck, New Jersey, 07666, United States
New Jersey Retina
Toms River, New Jersey, 08755, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
University of New Mexico, HSC
Albuquerque, New Mexico, 87131, United States
Sight MD
Brentwood, New York, 11717, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, 13088, United States
MaculaCare, PLLC
New York, New York, 10021, United States
New York Ear & Eye- East 85th
New York, New York, 10028, United States
Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
New York, New York, 10065, United States
Retina Associates of New York, Upper East Side
New York, New York, 10075, United States
Seeta Eye center
Poughkeepsie, New York, 12603, United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
NC Retina Associates
Cary, North Carolina, 27511, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Piedmont Retina Specialist
Winston-Salem, North Carolina, 27103, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43212, United States
Midwest Retina, Inc
Dublin, Ohio, 43016, United States
Retina Vitreous Center - Edmond
Edmond, Oklahoma, 73013, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, 74114, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Retina Northwest, The Highlands Building
Portland, Oregon, 97221, United States
EyeHealth Northwest
Portland, Oregon, 97225, United States
OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
Portland, Oregon, 97239, United States
Cascade Medical Research Institute LLC
Springfield, Oregon, 97477, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017, United States
Erie Retinal Surgery & Erie Retina Research
Erie, Pennsylvania, 16507, United States
Mid Atlantic Retina, Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Vision Research Solutions - the Eye Institute
Philadelphia, Pennsylvania, 19141, United States
Sewickley Eye Group
Sewickley, Pennsylvania, 15143, United States
Retina Consultants of Carolina
Greenville, South Carolina, 29605, United States
Charleston Neuroscience Institute LLC
Ladson, South Carolina, 29456, United States
Charleston Neuroscience Institute, LLC
Mt. Pleasant, South Carolina, 29464, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Austin Research Center for Retina
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research LLC
Austin, Texas, 78750, United States
Retina Consultants Texas
Bellaire, Texas, 77401, United States
Star Retina PLLC
Burleson, Texas, 76028, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Retina Consultants of Texas
Katy, Texas, 77494, United States
Valley Retina Institute, P.A.
McAllen, Texas, 78503, United States
Red River Research Partners (Formerly AXIS Clinical)
Plano, Texas, 75024, United States
Austin Retina Associates
Round Rock, Texas, 78681, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina Associates of South Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas Brown Retina Institute
San Antonio, Texas, 78251, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants Texas
The Woodlands, Texas, 77384, United States
Tyler Retina Research Institute- Ophthalmology
Tyler, Texas, 75703, United States
Retina Associates Of Utah Retina Specialist
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
Salt Lake Retina- Ophthalmology
West Jordan, Utah, 84088, United States
University of Vermont
Burlington, Vermont, 05401, United States
Southeastern Retina Associates
Bristol, Virginia, 24201, United States
Retina Group of Washington
Fairfax, Virginia, 22031, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Virginia Eye Institute
Richmond, Virginia, 23226, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
Medical University Graz
Graz, Styria, 8036, Austria
Medical University of Vienna
Vienna, 1090, Austria
VIROS - Vienna Institute for Research in Ocular Surgery
Vienna, 1140, Austria
Retina Centre of Ottawa - Department of Ophthalmology
Ottawa, Ontario, K2B 7E9, Canada
Centre Hospitalier Universitaire de Quebec Universite Laval
Québec, G1S 4L8, Canada
Centre Hospitalier Universitaire de Nice
Nice, Alpes Maritimes, 6002, France
Hopital Saint Joseph
Marseille, Bouches Du Rhone, 13008, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine, 86000, France
Toulouse University Hospital
Toulouse, Occitanie, 31059, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
Centre Hospitalier Universitaire Francois Mitterrand
Dijon, 21000, France
Hopital De La Croix-Rousse
Lyon, 69317, France
Pole Vision Val d'Ouest
Lyon, 69317, France
Centre Monticelli Paradis
Marseille, 13008, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44000, France
Hopital Lariboisiere
Paris, 75010, France
University of Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Charite - Universitaetsmedizin Berlin
Berlin, Brandenburg, 12203, Germany
Augenzentrum Frankfurt
Frankfurt am Main, Hesse, 60549, Germany
Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
Marburg, Hesse, 35043, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Klinikum Ludwigshafen Augenklinik
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Saarland University Medical Center
Homburg, Saarland, 66421, Germany
Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
Sulzbach, Saarland, 66280, Germany
University Hospital Hamburg Eppendorf
Hamburg, 20246, Germany
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, 55131, Germany
St. Franziskus-Hospital
Münster, 48145, Germany
Ganglion Medical Center
Pécs, Baranya, 7621, Hungary
University Of Szeged
Szeged, Csongrad-Csanad, 6720, Hungary
University Of Debrecen, Hungary
Debrecen, Hajdú-Bihar, 4032, Hungary
Semmelweis University
Budapest, 1085, Hungary
Budapest Retina Associates
Budapest, 1133, Hungary
University Hospital PTV
Rome, Lazio, 00133, Italy
Fondazione Policlinico Gemelli
Rome, Lazio, 00168, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
IRCCS MultiMedica
Milan, Lombardy, 20123, Italy
Ospedale San Raffaele (HSR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
Milan, Milano, 20132, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126, Italy
Universita degli Studi di Milano
Milan, 20157, Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Rome, 00184, Italy
Oftalmika Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631, Poland
Caminomed
Tarnowskie Góry, Silesian Voivodeship, 42-600, Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo
Olsztyn, Warmian-Masurian Voivodeship, 10-424, Poland
Hospital Arruzafa
Córdoba, Andalusia, 14012, Spain
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital de Terrassa (Consorci Sanitari de Terrassa)
Terrassa, Barcelona, 08227, Spain
Oftalvist Clinic. IMED Hospital
Burjassot, Valencia, 46100, Spain
Centro de Oftalmologia Barraquer
Barcelona, 08021, Spain
Instituto de Microcirugia Ocular
Barcelona, 08035, Spain
Institut Catala De Retina S.L.
Barcelona, 8022, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Fundacion Aiken De La Comunitat Valenciana
Valencia, 46004, Spain
Hospital Clinico Universitario Lozano Blesa. IIS Aragon
Zaragoza, 50009, Spain
Miguel Servet University Hospital
Zaragoza, 50009, Spain
Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
Liverpool, Merseyside, L7 8XP, United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, YP31 8HE, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 2LX, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Imperial College Healthcare NHS Trust
London, NW1 5QH, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2024
First Posted
August 7, 2024
Study Start
October 30, 2024
Primary Completion (Estimated)
November 29, 2027
Study Completion (Estimated)
May 21, 2032
Last Updated
May 7, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.