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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03888105




Registration number
NCT03888105
Ethics application status
Date submitted
14/03/2019
Date registered
25/03/2019

Titles & IDs
Public title
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
Scientific title
An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
2017-002139-41
Secondary ID [2] 0 0
R1979-ONC-1625
Universal Trial Number (UTN)
Trial acronym
ELM-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Non-Hodgkin Lymphoma (B-NHL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Odronextamab

Experimental: FL - Follicular lymphoma grade 1-3a cohort

Experimental: DLBCL - Diffuse large B-cell lymphoma cohort

Experimental: MCL - Mantle Cell Lymphoma cohort

Experimental: MZL - Marginal Zone Lymphoma cohort

Experimental: Other B-NHL - Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed


Treatment: Drugs: Odronextamab
Administered by intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR), as assessed by independent central review
Timepoint [1] 0 0
Up to 52 weeks of study treatment
Primary outcome [2] 0 0
ORR, as assessed by independent central review
Timepoint [2] 0 0
Up to 36 weeks of study treatment
Secondary outcome [1] 0 0
ORR, as assessed by the local investigator
Timepoint [1] 0 0
Up to 52 weeks of study treatment
Secondary outcome [2] 0 0
ORR, as assessed by the local investigator
Timepoint [2] 0 0
Up to 36 weeks of study treatment
Secondary outcome [3] 0 0
Complete response (CR) rate, as assessed by the local investigator
Timepoint [3] 0 0
Up to 52 weeks of study treatment
Secondary outcome [4] 0 0
CR rate, as assessed by independent central review
Timepoint [4] 0 0
Up to 52 weeks of study treatment
Secondary outcome [5] 0 0
CR rate, as assessed by the local investigator
Timepoint [5] 0 0
Up to 36 weeks of study treatment
Secondary outcome [6] 0 0
CR rate, as assessed by independent central review
Timepoint [6] 0 0
Up to 36 weeks of study treatment
Secondary outcome [7] 0 0
Progression-free survival (PFS), as assessed by independent central review
Timepoint [7] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [8] 0 0
PFS, as assessed by the local investigator
Timepoint [8] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [9] 0 0
Overall survival (OS)
Timepoint [9] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [10] 0 0
Duration of response (DOR), as assessed by independent central review
Timepoint [10] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [11] 0 0
DOR, as assessed by the local investigator
Timepoint [11] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [12] 0 0
Disease control rate (DCR), as assessed by independent central review
Timepoint [12] 0 0
Up to 52 weeks of study treatment
Secondary outcome [13] 0 0
DCR, as assessed by the local ivestigator
Timepoint [13] 0 0
Up to 52 weeks of study treatment
Secondary outcome [14] 0 0
DCR, as assessed by independent central review
Timepoint [14] 0 0
Up to 36 weeks of study treatment
Secondary outcome [15] 0 0
DCR, as assessed by the local investigator
Timepoint [15] 0 0
Up to 36 weeks of study treatment
Secondary outcome [16] 0 0
Incidence and severity of treatment emergent adverse events (TEAEs)
Timepoint [16] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [17] 0 0
Concentration of odronextamab
Timepoint [17] 0 0
12 weeks following end of treatment
Secondary outcome [18] 0 0
Incidence of anti-drug antibodies (ADA) to odronextamab over time
Timepoint [18] 0 0
12 weeks following end of treatment
Secondary outcome [19] 0 0
Titer of anti-drug antibodies to odronextamab over time
Timepoint [19] 0 0
12 weeks following end of treatment
Secondary outcome [20] 0 0
Incidence of neutralizing antibodies (Nab) to odronextamab over time
Timepoint [20] 0 0
12 weeks following end of treatment
Secondary outcome [21] 0 0
Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
Timepoint [21] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [22] 0 0
Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym)
Timepoint [22] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [23] 0 0
Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)
Timepoint [23] 0 0
Approximately 194 weeks following the first dose

Eligibility
Key inclusion criteria
Key

1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
2. Disease-specific cohorts:

Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment.
* FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
* DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
* MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
* MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
* Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
3. History of allogeneic stem cell transplantation
4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
8. Known hypersensitivity to both allopurinol and rasburicase
9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 2
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
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/12/2029
Actual
Sample size
Target
576
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,South WalesVIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [2] 0 0
Northern NSW Local Health District The Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [4] 0 0
North Building - Frankston
Recruitment hospital [5] 0 0
Olivia Newton John Cancer Wellness & Research Centre - Heidelberg
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [8] 0 0
Andrew Love Cancer Center - Tweed Heads
Recruitment postcode(s) [1] 0 0
2640 - East Albury
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
VIC 3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
VIC3220 - Tweed Heads
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
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
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Chongqing
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Heilongjiang
Country [20] 0 0
China
State/province [20] 0 0
Henan
Country [21] 0 0
China
State/province [21] 0 0
Hubei
Country [22] 0 0
China
State/province [22] 0 0
Jiangsu
Country [23] 0 0
China
State/province [23] 0 0
Jilin
Country [24] 0 0
China
State/province [24] 0 0
Shaanxi
Country [25] 0 0
China
State/province [25] 0 0
Shanghai
Country [26] 0 0
China
State/province [26] 0 0
Sichuan
Country [27] 0 0
China
State/province [27] 0 0
Tianjin
Country [28] 0 0
China
State/province [28] 0 0
Zhejiang
Country [29] 0 0
France
State/province [29] 0 0
Aquitaine
Country [30] 0 0
France
State/province [30] 0 0
Calvados
Country [31] 0 0
France
State/province [31] 0 0
Ile-de-France
Country [32] 0 0
France
State/province [32] 0 0
Loire
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France
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Lyon
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France
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Nord
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France
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Vienne
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France
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Paris
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Germany
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Donaueschingen
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Germany
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Gmund
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Germany
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Chemnitz
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Germany
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Halle Saale
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Germany
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Wurzburg
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Italy
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Foggia
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Italy
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Milan
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Italy
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Bologna
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Italy
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Firenze
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Italy
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Livorno
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Italy
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Milano
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Italy
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Novara
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Italy
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Perugia
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Italy
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Ravenna
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Italy
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Reggio Emilia
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Italy
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Terni
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Italy
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Varese
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Italy
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Venice
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Japan
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Aichi
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Aiti
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Chiba-ken
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Ehime
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Kanagawa
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Kyoto
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Osaka
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Saitama
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Tiba
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Tokyo
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Yamagata Prefecture
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Nagasaki
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Korea, Republic of
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Daegu
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Gyeonggi
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Poland
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Malopolskie
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Singapore
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Singapore
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Spain
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Balearic Islands
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Spain
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Catalonia
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Spain
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Gipuzkoa
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Spain
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Illes Balears
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Barcelona
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Spain
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Salamanca
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Spain
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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Taiwan
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Taichung City
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Taiwan
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Tainan City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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United Kingdom
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Cornwall
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United Kingdom
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Devon
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United Kingdom
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Scotland
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United Kingdom
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Surrey
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United Kingdom
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Wales
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United Kingdom
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London

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT03888105