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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05730036




Registration number
NCT05730036
Ethics application status
Date submitted
6/02/2023
Date registered
15/02/2023

Titles & IDs
Public title
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Secondary ID [1] 0 0
2022-501396-62-00
Secondary ID [2] 0 0
R5458-ONC-2245
Universal Trial Number (UTN)
Trial acronym
LINKER-MM3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed Refractory Multiple Myeloma (RRMM) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Linvoseltamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone

Experimental: Linvoseltamab - Randomization 1:1

Active comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd) - Randomization 1:1


Treatment: Drugs: Linvoseltamab
REGN5458 will be administered by intravenous (IV) infusion

Treatment: Drugs: Elotuzumab
Elotuzumab will be administered by IV infusion

Treatment: Drugs: Pomalidomide
Pomalidomide capsules will administered by mouth (PO)

Treatment: Drugs: Dexamethasone
Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
Timepoint [1] 0 0
Up to approximatively 5 years
Secondary outcome [1] 0 0
PFS per IMWG response criteria determined by IRC in all participants
Timepoint [1] 0 0
Up to approximatively 5 years
Secondary outcome [2] 0 0
Objective Response (OR) of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
Timepoint [2] 0 0
Up to approximatively 5 years
Secondary outcome [3] 0 0
OR of PR or better per IMWG response criteria as determined by the IRC in all participants
Timepoint [3] 0 0
Up to approximatively 5 years
Secondary outcome [4] 0 0
OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Timepoint [4] 0 0
Up to approximatively 5 years
Secondary outcome [5] 0 0
OR of VGPR or better per IMWG response criteria as determined by IRC in all participants
Timepoint [5] 0 0
Up to approximatively 5 years
Secondary outcome [6] 0 0
OR of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Timepoint [6] 0 0
Up to approximatively 5 years
Secondary outcome [7] 0 0
OR of CR or better per IMWG response criteria as determined by IRC in all participants
Timepoint [7] 0 0
Up to approximatively 5 years
Secondary outcome [8] 0 0
Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies
Timepoint [8] 0 0
Up to approximatively 5 years
Secondary outcome [9] 0 0
Incidence of MRD negative status in all participants
Timepoint [9] 0 0
Up to approximatively 5 years
Secondary outcome [10] 0 0
Overall Survival (OS) in participants previously exposed to CD38 antibodies
Timepoint [10] 0 0
Up to approximatively 5 years
Secondary outcome [11] 0 0
OS in all participants
Timepoint [11] 0 0
Up to approximatively 5 years
Secondary outcome [12] 0 0
Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies
Timepoint [12] 0 0
Baseline to week 12
Secondary outcome [13] 0 0
Mean change in the worst pain score measured by BPI-SF Item 3 in all participants
Timepoint [13] 0 0
Baseline to week 12
Secondary outcome [14] 0 0
Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies
Timepoint [14] 0 0
Up to approximatively 5 years
Secondary outcome [15] 0 0
Incidence TEAEs in all participants
Timepoint [15] 0 0
Up to approximatively 5 years
Secondary outcome [16] 0 0
Severity of TEAEs in participants previously exposed to CD38 antibodies
Timepoint [16] 0 0
Up to approximatively 5 years
Secondary outcome [17] 0 0
Severity of TEAEs in all participants
Timepoint [17] 0 0
Up to approximatively 5 years
Secondary outcome [18] 0 0
Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies
Timepoint [18] 0 0
Up to approximatively 5 years
Secondary outcome [19] 0 0
Incidence of AESI in all participants
Timepoint [19] 0 0
Up to approximatively 5 years
Secondary outcome [20] 0 0
Severity of AESI in participants previously exposed to CD38 antibodies
Timepoint [20] 0 0
Up to approximatively 5 years
Secondary outcome [21] 0 0
Severity AESI in all participants
Timepoint [21] 0 0
Up to approximatively 5 years
Secondary outcome [22] 0 0
Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies
Timepoint [22] 0 0
Up to approximatively 5 years
Secondary outcome [23] 0 0
Incidence of SAE in all participants
Timepoint [23] 0 0
Up to approximatively 5 years
Secondary outcome [24] 0 0
Severity of SAE in participants previously exposed to CD38 antibodies
Timepoint [24] 0 0
Up to approximatively 5 years
Secondary outcome [25] 0 0
Severity of SAE in all participants
Timepoint [25] 0 0
Up to approximatively 5 years
Secondary outcome [26] 0 0
PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [26] 0 0
Up to approximatively 5 years
Secondary outcome [27] 0 0
PFS per IMWG response criteria as determined by the investigator in all participants
Timepoint [27] 0 0
Up to approximatively 5 years
Secondary outcome [28] 0 0
OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [28] 0 0
Up to approximatively 5 years
Secondary outcome [29] 0 0
OR of PR or better per IMWG response criteria as determined by the investigator in all participants
Timepoint [29] 0 0
Up to approximatively 5 years
Secondary outcome [30] 0 0
OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [30] 0 0
Up to approximatively 5 years
Secondary outcome [31] 0 0
OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants
Timepoint [31] 0 0
Up to approximatively 5 years
Secondary outcome [32] 0 0
OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [32] 0 0
Up to approximatively 5 years
Secondary outcome [33] 0 0
OR of CR or better per IMWG response criteria as determined by the investigator in all participants
Timepoint [33] 0 0
Up to approximatively 5 years
Secondary outcome [34] 0 0
Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [34] 0 0
Up to approximatively 5 years
Secondary outcome [35] 0 0
DoR as per IMWG response criteria as determined by the investigator in all participants
Timepoint [35] 0 0
Up to approximatively 5 years
Secondary outcome [36] 0 0
DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Timepoint [36] 0 0
Up to approximatively 5 years
Secondary outcome [37] 0 0
DoR as per IMWG response criteria as determined by the IRC in all participants
Timepoint [37] 0 0
Up to approximatively 5 years
Secondary outcome [38] 0 0
Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies
Timepoint [38] 0 0
Up to approximatively 5 years
Secondary outcome [39] 0 0
Duration of MRD negative status in the bone marrow in all participants
Timepoint [39] 0 0
Up to approximatively 5 years
Secondary outcome [40] 0 0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Timepoint [40] 0 0
Up to approximatively 5 years
Secondary outcome [41] 0 0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in all participants
Timepoint [41] 0 0
Up to approximatively 5 years
Secondary outcome [42] 0 0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Timepoint [42] 0 0
Up to approximatively 5 years
Secondary outcome [43] 0 0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in all participants
Timepoint [43] 0 0
Up to approximatively 5 years
Secondary outcome [44] 0 0
Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies
Timepoint [44] 0 0
Up to approximatively 5 years
Secondary outcome [45] 0 0
Concentration of linvoseltamab in the serum over time in all participants
Timepoint [45] 0 0
Up to approximatively 5 years
Secondary outcome [46] 0 0
Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies
Timepoint [46] 0 0
Up to approximatively 5 years
Secondary outcome [47] 0 0
Incidence of ADAs in all participants
Timepoint [47] 0 0
Up to approximatively 5 years
Secondary outcome [48] 0 0
Titer of ADAs in participants previously exposed to CD38 antibodies
Timepoint [48] 0 0
Up to approximatively 5 years
Secondary outcome [49] 0 0
Titer of ADAs in all participants
Timepoint [49] 0 0
Up to approximatively 5 years
Secondary outcome [50] 0 0
Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies
Timepoint [50] 0 0
Up to approximatively 5 years
Secondary outcome [51] 0 0
Incidence of Nabs to linvoseltamab over time in all participants
Timepoint [51] 0 0
Up to approximatively 5 years
Secondary outcome [52] 0 0
Proportion of Pain Responders in participants previously exposed to CD38 antibodies
Timepoint [52] 0 0
At week 12
Secondary outcome [53] 0 0
Proportion of Pain Responders in all participants
Timepoint [53] 0 0
At week 12
Secondary outcome [54] 0 0
Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies
Timepoint [54] 0 0
Baseline to week 12
Secondary outcome [55] 0 0
Change in patient-reported QoL, per EORTC QLQ-C30 in all participants
Timepoint [55] 0 0
Baseline to week 12
Secondary outcome [56] 0 0
Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies
Timepoint [56] 0 0
Baseline to week 12
Secondary outcome [57] 0 0
Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants
Timepoint [57] 0 0
Baseline to week 12
Secondary outcome [58] 0 0
Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies
Timepoint [58] 0 0
Baseline to week 12
Secondary outcome [59] 0 0
Patient-Reported Outcomes in PGIS in all participants
Timepoint [59] 0 0
Baseline to week 12
Secondary outcome [60] 0 0
Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies
Timepoint [60] 0 0
Baseline to week 12
Secondary outcome [61] 0 0
Patient-Reported Outcomes in PGIC in all participants
Timepoint [61] 0 0
Baseline to week 12
Secondary outcome [62] 0 0
Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies
Timepoint [62] 0 0
Baseline to week 12
Secondary outcome [63] 0 0
Change in patient-reported general health status per EQ-5D-5L in all participants
Timepoint [63] 0 0
Baseline to week 12

Eligibility
Key inclusion criteria
Key

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status =1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
6. Life expectancy of at least 6 months

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/12/2032
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [4] 0 0
Integrated Clinical Oncology Network - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide hospital - Adelaide
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [8] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [9] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [10] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [11] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
7250 - Launceston
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3065 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Namur
Country [10] 0 0
Belgium
State/province [10] 0 0
West-Vlaanderen
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerp
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Brazil
State/province [13] 0 0
Bahia
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grade Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio Grande Do Sul
Country [16] 0 0
Brazil
State/province [16] 0 0
Santa Catarina
Country [17] 0 0
Brazil
State/province [17] 0 0
Curitiba
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio de Janeiro
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Chile
State/province [22] 0 0
Las Condes
Country [23] 0 0
Chile
State/province [23] 0 0
Valparaiso
Country [24] 0 0
Chile
State/province [24] 0 0
Santiago
Country [25] 0 0
France
State/province [25] 0 0
Gironde
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Lyon
Country [29] 0 0
Germany
State/province [29] 0 0
Baden-Wuerttemberg
Country [30] 0 0
Germany
State/province [30] 0 0
Saxony
Country [31] 0 0
Germany
State/province [31] 0 0
Hamburg
Country [32] 0 0
Germany
State/province [32] 0 0
Luebeck
Country [33] 0 0
Israel
State/province [33] 0 0
Hamerkaz
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Aviv
Country [37] 0 0
Italy
State/province [37] 0 0
Foggia
Country [38] 0 0
Italy
State/province [38] 0 0
Forli Cesena
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardy
Country [40] 0 0
Italy
State/province [40] 0 0
Alessandria
Country [41] 0 0
Italy
State/province [41] 0 0
Ancona
Country [42] 0 0
Italy
State/province [42] 0 0
Bologna
Country [43] 0 0
Italy
State/province [43] 0 0
Genova
Country [44] 0 0
Italy
State/province [44] 0 0
Pavia
Country [45] 0 0
Italy
State/province [45] 0 0
Ravenna
Country [46] 0 0
Italy
State/province [46] 0 0
Reggio Emilia
Country [47] 0 0
Italy
State/province [47] 0 0
Torino
Country [48] 0 0
Italy
State/province [48] 0 0
Turin
Country [49] 0 0
Italy
State/province [49] 0 0
Viagrande
Country [50] 0 0
Japan
State/province [50] 0 0
Tokushima
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Busan
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Hwasun
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Incheon
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Jeonju
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Netherlands
State/province [56] 0 0
Gelderland
Country [57] 0 0
Netherlands
State/province [57] 0 0
Zuid-Holland
Country [58] 0 0
Poland
State/province [58] 0 0
Kujawsko-pomorskie
Country [59] 0 0
Poland
State/province [59] 0 0
Lodzkie
Country [60] 0 0
Poland
State/province [60] 0 0
Lubelskie
Country [61] 0 0
Poland
State/province [61] 0 0
Pomorskie
Country [62] 0 0
Poland
State/province [62] 0 0
Katowice
Country [63] 0 0
Singapore
State/province [63] 0 0
Kent Ridge
Country [64] 0 0
Singapore
State/province [64] 0 0
Singapore
Country [65] 0 0
Spain
State/province [65] 0 0
Asturias
Country [66] 0 0
Spain
State/province [66] 0 0
Baleares
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Cantabria
Country [69] 0 0
Spain
State/province [69] 0 0
Islas Baleares
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Spain
State/province [71] 0 0
Navarra
Country [72] 0 0
Spain
State/province [72] 0 0
Alicante
Country [73] 0 0
Spain
State/province [73] 0 0
Girona
Country [74] 0 0
Spain
State/province [74] 0 0
Leon
Country [75] 0 0
Spain
State/province [75] 0 0
Malaga
Country [76] 0 0
Spain
State/province [76] 0 0
Santiago de Compostela
Country [77] 0 0
Spain
State/province [77] 0 0
Seville
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Spain
State/province [79] 0 0
Vitoria-Gasteiz
Country [80] 0 0
Spain
State/province [80] 0 0
Zaragoza
Country [81] 0 0
Taiwan
State/province [81] 0 0
Changhua County
Country [82] 0 0
Taiwan
State/province [82] 0 0
Hualien City
Country [83] 0 0
Taiwan
State/province [83] 0 0
Kaohsiung
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taichung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Tainan
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taoyuan
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Scotland
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Surrey
Country [90] 0 0
United Kingdom
State/province [90] 0 0
West Midlands
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Cambridge
Country [92] 0 0
United Kingdom
State/province [92] 0 0
London
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
clinicaltrials@regeneron.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05730036