Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05578976




Registration number
NCT05578976
Ethics application status
Date submitted
12/10/2022
Date registered
13/10/2022

Titles & IDs
Public title
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Scientific title
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
2023-505277-32
Secondary ID [2] 0 0
M20-621
Universal Trial Number (UTN)
Trial acronym
EPCORE DLBCL-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 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 - Epcoritamab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Rituximab
Treatment: Drugs - Vincristine
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Prednisone

Experimental: Epcoritamab and R-CHOP - Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.

Experimental: R-CHOP and Rituximab - Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.


Treatment: Drugs: Epcoritamab
Subcutaneous Injection (SC)

Treatment: Drugs: Cyclophosphamide
Intravenous (IV) Injection

Treatment: Drugs: Rituximab
IV Infusion

Treatment: Drugs: Vincristine
IV Infusion

Treatment: Drugs: Doxorubicin
IV Infusion

Treatment: Drugs: Prednisone
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
Timepoint [1] 0 0
Up to Approximately 46 Months
Secondary outcome [1] 0 0
Number of Participants with PFS
Timepoint [1] 0 0
Up to Approximately 46 Months
Secondary outcome [2] 0 0
Number of Participants with Event-free survival (EFS)
Timepoint [2] 0 0
Up to Approximately 46 Months
Secondary outcome [3] 0 0
Percentage of Participants with Complete Remission (CR)
Timepoint [3] 0 0
On or After to Approximately 28 Weeks
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to Approximately 76 Months
Secondary outcome [5] 0 0
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Timepoint [5] 0 0
Up to Approximately 46 Months

Eligibility
Key inclusion criteria
* Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
* Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

* DLBCL, Not Otherwise Specified (NOS).
* High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
* T-cell/histiocyte-rich large B-cell lymphoma.
* Epstein Barr virus-positive DLBCL, NOS.
* Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

* Availability of archival or fresh or paraffin embedded tissue at Screening.
* Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
* Has at least one target lesion defined as:

* >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
* Positron emission tomography (PET)-positive on PET-CT scan.
* Laboratory values meeting the criteria laid out in the protocol.
* Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
* Clinically significant cardiovascular disease as per the protocol.

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
8/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2029
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 230072 - Liverpool
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 225683 - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre /ID# 225680 - Clayton
Recruitment hospital [4] 0 0
Austin Health /ID# 225716 - Heidelberg
Recruitment hospital [5] 0 0
The Alfred Hospital /ID# 225999 - Melbourne
Recruitment hospital [6] 0 0
Hollywood Private Hospital /ID# 251837 - Nedlands
Recruitment hospital [7] 0 0
Perth Blood Institute Ltd /ID# 225679 - Nedlands
Recruitment hospital [8] 0 0
Royal Perth Hospital /ID# 226583 - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Austria
State/province [28] 0 0
Niederoesterreich
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles-Capitale
Country [32] 0 0
Belgium
State/province [32] 0 0
Hainaut
Country [33] 0 0
Belgium
State/province [33] 0 0
Liege
Country [34] 0 0
Belgium
State/province [34] 0 0
Limburg
Country [35] 0 0
Belgium
State/province [35] 0 0
Namur
Country [36] 0 0
Belgium
State/province [36] 0 0
Oost-Vlaanderen
Country [37] 0 0
Belgium
State/province [37] 0 0
Vlaams-Brabant
Country [38] 0 0
Belgium
State/province [38] 0 0
West-Vlaanderen
Country [39] 0 0
Belgium
State/province [39] 0 0
Anderlecht
Country [40] 0 0
Belgium
State/province [40] 0 0
Antwerp
Country [41] 0 0
Belgium
State/province [41] 0 0
Brugge
Country [42] 0 0
Brazil
State/province [42] 0 0
Parana
Country [43] 0 0
Brazil
State/province [43] 0 0
Sao Paulo
Country [44] 0 0
Brazil
State/province [44] 0 0
Rio de Janeiro
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Smolyan
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Plovdiv
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Sofia
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Saskatchewan
Country [52] 0 0
China
State/province [52] 0 0
Beijing
Country [53] 0 0
China
State/province [53] 0 0
Fujian
Country [54] 0 0
China
State/province [54] 0 0
Guangdong
Country [55] 0 0
China
State/province [55] 0 0
Hebei
Country [56] 0 0
China
State/province [56] 0 0
Heilongjiang
Country [57] 0 0
China
State/province [57] 0 0
Henan
Country [58] 0 0
China
State/province [58] 0 0
Hubei
Country [59] 0 0
China
State/province [59] 0 0
Jiangsu
Country [60] 0 0
China
State/province [60] 0 0
Jiangxi
Country [61] 0 0
China
State/province [61] 0 0
Jilin
Country [62] 0 0
China
State/province [62] 0 0
Liaoning
Country [63] 0 0
China
State/province [63] 0 0
Shandong
Country [64] 0 0
China
State/province [64] 0 0
Shanghai
Country [65] 0 0
China
State/province [65] 0 0
Shanxi
Country [66] 0 0
China
State/province [66] 0 0
Tianjin
Country [67] 0 0
China
State/province [67] 0 0
Zhejiang
Country [68] 0 0
Croatia
State/province [68] 0 0
Grad Zagreb
Country [69] 0 0
Croatia
State/province [69] 0 0
Primorsko-goranska Zupanija
Country [70] 0 0
Croatia
State/province [70] 0 0
Splitsko-dalmatinska Zupanija
Country [71] 0 0
Croatia
State/province [71] 0 0
Slavonski Brod
Country [72] 0 0
Czechia
State/province [72] 0 0
Praha 17
Country [73] 0 0
Czechia
State/province [73] 0 0
Brno
Country [74] 0 0
Czechia
State/province [74] 0 0
Prague
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha
Country [76] 0 0
Denmark
State/province [76] 0 0
Hovedstaden
Country [77] 0 0
Denmark
State/province [77] 0 0
Midtjylland
Country [78] 0 0
Denmark
State/province [78] 0 0
Sjælland
Country [79] 0 0
Denmark
State/province [79] 0 0
Syddanmark
Country [80] 0 0
France
State/province [80] 0 0
Alpes-Maritimes
Country [81] 0 0
France
State/province [81] 0 0
Bouches-du-Rhone
Country [82] 0 0
France
State/province [82] 0 0
Bretagne
Country [83] 0 0
France
State/province [83] 0 0
Cote-d Or
Country [84] 0 0
France
State/province [84] 0 0
Franche-Comte
Country [85] 0 0
France
State/province [85] 0 0
Haute-Corse
Country [86] 0 0
France
State/province [86] 0 0
Herault
Country [87] 0 0
France
State/province [87] 0 0
Isere
Country [88] 0 0
France
State/province [88] 0 0
Meurthe-et-Moselle
Country [89] 0 0
France
State/province [89] 0 0
Nord
Country [90] 0 0
France
State/province [90] 0 0
Paris
Country [91] 0 0
France
State/province [91] 0 0
Pays-de-la-Loire
Country [92] 0 0
France
State/province [92] 0 0
Pyrenees-Atlantiques
Country [93] 0 0
France
State/province [93] 0 0
Rhone
Country [94] 0 0
France
State/province [94] 0 0
Somme
Country [95] 0 0
France
State/province [95] 0 0
Vendee
Country [96] 0 0
France
State/province [96] 0 0
Vienne
Country [97] 0 0
France
State/province [97] 0 0
Angers
Country [98] 0 0
France
State/province [98] 0 0
Caen
Country [99] 0 0
France
State/province [99] 0 0
Saint-cloud
Country [100] 0 0
Greece
State/province [100] 0 0
Attiki
Country [101] 0 0
Greece
State/province [101] 0 0
Athens
Country [102] 0 0
Greece
State/province [102] 0 0
Ioannina
Country [103] 0 0
Greece
State/province [103] 0 0
Thessaloniki
Country [104] 0 0
Hungary
State/province [104] 0 0
Gyor-Moson-Sopron
Country [105] 0 0
Hungary
State/province [105] 0 0
Hajdu-Bihar
Country [106] 0 0
Hungary
State/province [106] 0 0
Somogy
Country [107] 0 0
Hungary
State/province [107] 0 0
Tolna
Country [108] 0 0
Hungary
State/province [108] 0 0
Vas
Country [109] 0 0
Hungary
State/province [109] 0 0
Budapest
Country [110] 0 0
Hungary
State/province [110] 0 0
Szeged
Country [111] 0 0
Israel
State/province [111] 0 0
H_efa
Country [112] 0 0
Israel
State/province [112] 0 0
HaMerkaz
Country [113] 0 0
Israel
State/province [113] 0 0
Tel-Aviv
Country [114] 0 0
Israel
State/province [114] 0 0
Yerushalayim
Country [115] 0 0
Israel
State/province [115] 0 0
Haifa
Country [116] 0 0
Italy
State/province [116] 0 0
Foggia
Country [117] 0 0
Italy
State/province [117] 0 0
L Aquila
Country [118] 0 0
Italy
State/province [118] 0 0
Milano
Country [119] 0 0
Italy
State/province [119] 0 0
Torino
Country [120] 0 0
Italy
State/province [120] 0 0
Alessandria
Country [121] 0 0
Italy
State/province [121] 0 0
Aviano
Country [122] 0 0
Italy
State/province [122] 0 0
Brescia
Country [123] 0 0
Italy
State/province [123] 0 0
Novara
Country [124] 0 0
Italy
State/province [124] 0 0
Palermo
Country [125] 0 0
Italy
State/province [125] 0 0
Pisa
Country [126] 0 0
Italy
State/province [126] 0 0
Ravenna
Country [127] 0 0
Japan
State/province [127] 0 0
Aichi
Country [128] 0 0
Japan
State/province [128] 0 0
Chiba
Country [129] 0 0
Japan
State/province [129] 0 0
Ehime
Country [130] 0 0
Japan
State/province [130] 0 0
Fukuoka
Country [131] 0 0
Japan
State/province [131] 0 0
Fukushima
Country [132] 0 0
Japan
State/province [132] 0 0
Hokkaido
Country [133] 0 0
Japan
State/province [133] 0 0
Hyogo
Country [134] 0 0
Japan
State/province [134] 0 0
Ibaraki
Country [135] 0 0
Japan
State/province [135] 0 0
Ishikawa
Country [136] 0 0
Japan
State/province [136] 0 0
Kagoshima
Country [137] 0 0
Japan
State/province [137] 0 0
Kanagawa
Country [138] 0 0
Japan
State/province [138] 0 0
Miyagi
Country [139] 0 0
Japan
State/province [139] 0 0
Osaka
Country [140] 0 0
Japan
State/province [140] 0 0
Tokyo
Country [141] 0 0
Japan
State/province [141] 0 0
Yamagata
Country [142] 0 0
Japan
State/province [142] 0 0
Okayama
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Busan Gwang Yeogsi
Country [144] 0 0
Korea, Republic of
State/province [144] 0 0
Gyeonggido
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Gyeongsangbugdo
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Gyeongsangnamdo
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Jeonrabugdo
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Seoul Teugbyeolsi
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Ulsan Gwang Yeogsi
Country [150] 0 0
Netherlands
State/province [150] 0 0
Flevoland
Country [151] 0 0
Netherlands
State/province [151] 0 0
Gelderland
Country [152] 0 0
Netherlands
State/province [152] 0 0
Noord-Brabant
Country [153] 0 0
Netherlands
State/province [153] 0 0
Noord-Holland
Country [154] 0 0
Netherlands
State/province [154] 0 0
Zuid-Holland
Country [155] 0 0
Netherlands
State/province [155] 0 0
Den Haag
Country [156] 0 0
Netherlands
State/province [156] 0 0
Deventer
Country [157] 0 0
Netherlands
State/province [157] 0 0
Groningen
Country [158] 0 0
Netherlands
State/province [158] 0 0
S Hertogenbosch
Country [159] 0 0
Netherlands
State/province [159] 0 0
Utrecht
Country [160] 0 0
New Zealand
State/province [160] 0 0
Auckland
Country [161] 0 0
New Zealand
State/province [161] 0 0
Canterbury
Country [162] 0 0
Poland
State/province [162] 0 0
Pomorskie
Country [163] 0 0
Poland
State/province [163] 0 0
Swietokrzyskie
Country [164] 0 0
Poland
State/province [164] 0 0
Warminsko-mazurskie
Country [165] 0 0
Poland
State/province [165] 0 0
Wielkopolskie
Country [166] 0 0
Portugal
State/province [166] 0 0
Braga
Country [167] 0 0
Portugal
State/province [167] 0 0
Lisboa
Country [168] 0 0
Portugal
State/province [168] 0 0
Porto
Country [169] 0 0
Puerto Rico
State/province [169] 0 0
Curitiba
Country [170] 0 0
Puerto Rico
State/province [170] 0 0
Manati
Country [171] 0 0
Puerto Rico
State/province [171] 0 0
Rio Piedras
Country [172] 0 0
Slovakia
State/province [172] 0 0
Bratislavsky Kraj
Country [173] 0 0
Slovakia
State/province [173] 0 0
Zilinsky Kraj
Country [174] 0 0
South Africa
State/province [174] 0 0
Gauteng
Country [175] 0 0
South Africa
State/province [175] 0 0
Western Cape
Country [176] 0 0
Spain
State/province [176] 0 0
Barcelona
Country [177] 0 0
Spain
State/province [177] 0 0
Cordoba
Country [178] 0 0
Spain
State/province [178] 0 0
Murcia
Country [179] 0 0
Spain
State/province [179] 0 0
Navarra
Country [180] 0 0
Spain
State/province [180] 0 0
Madrid
Country [181] 0 0
Spain
State/province [181] 0 0
Valencia
Country [182] 0 0
Sweden
State/province [182] 0 0
Skane Lan
Country [183] 0 0
Sweden
State/province [183] 0 0
Sodermanlands Lan
Country [184] 0 0
Sweden
State/province [184] 0 0
Stockholms Lan
Country [185] 0 0
Sweden
State/province [185] 0 0
Vastra Gotalands Lan
Country [186] 0 0
Switzerland
State/province [186] 0 0
Aargau
Country [187] 0 0
Switzerland
State/province [187] 0 0
Bern
Country [188] 0 0
Switzerland
State/province [188] 0 0
Zuerich
Country [189] 0 0
Taiwan
State/province [189] 0 0
Kaohsiung
Country [190] 0 0
Taiwan
State/province [190] 0 0
Keelung
Country [191] 0 0
Taiwan
State/province [191] 0 0
Taichung
Country [192] 0 0
Turkey
State/province [192] 0 0
Adana
Country [193] 0 0
Turkey
State/province [193] 0 0
Kocaeli
Country [194] 0 0
Turkey
State/province [194] 0 0
Malatya
Country [195] 0 0
Turkey
State/province [195] 0 0
Samsun
Country [196] 0 0
Turkey
State/province [196] 0 0
Yuregir
Country [197] 0 0
United Kingdom
State/province [197] 0 0
London, City Of
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Norfolk
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Birmingham
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Edinburgh

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
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?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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/NCT05578976