Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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/NCT05882877




Registration number
NCT05882877
Ethics application status
Date submitted
22/05/2023
Date registered
31/05/2023

Titles & IDs
Public title
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Scientific title
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Secondary ID [1] 0 0
2022-501587-17
Secondary ID [2] 0 0
20210146
Universal Trial Number (UTN)
Trial acronym
ROCKET-ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Other interventions - Placebo

Experimental: ARM A: Dose 1 to Dose 1 - Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.

Experimental: ARM B: Dose 2 to Dose 2 - Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.

Placebo comparator: ARM C: Dose 1 or Dose 2 to Placebo - Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.

Placebo comparator: ARM D: Placebo to Placebo - Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.

Experimental: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 - Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W.

All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.


Treatment: Drugs: Rocatinlimab
Subcutaneous (SC) injection

Other interventions: Placebo
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Up to 116 weeks
Secondary outcome [1] 0 0
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1
Timepoint [1] 0 0
Week 32
Secondary outcome [2] 0 0
Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA 0/1 Response at Day 1
Timepoint [2] 0 0
Week 32
Secondary outcome [3] 0 0
Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1
Timepoint [3] 0 0
Week 32
Secondary outcome [4] 0 0
Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1
Timepoint [4] 0 0
Week 32
Secondary outcome [5] 0 0
Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1
Timepoint [5] 0 0
Week 32
Secondary outcome [6] 0 0
Maintaining >= 4-point reduction from parent study baseline in worst pruritus NRS score at week 32
Timepoint [6] 0 0
Week 32

Eligibility
Key inclusion criteria
* Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
Minimum age
12 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2027
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment hospital [2] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - South Brisbane
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment hospital [9] 0 0
Skin Health Institute - Carlton
Recruitment hospital [10] 0 0
Monash Childrens Hospital - Clayton
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
South Dakota
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Distrito Federal
Country [36] 0 0
Argentina
State/province [36] 0 0
Santa Fe
Country [37] 0 0
Austria
State/province [37] 0 0
Graz
Country [38] 0 0
Austria
State/province [38] 0 0
Salzburg
Country [39] 0 0
Belgium
State/province [39] 0 0
Bruxelles
Country [40] 0 0
Belgium
State/province [40] 0 0
Charleroi
Country [41] 0 0
Belgium
State/province [41] 0 0
Gent
Country [42] 0 0
Belgium
State/province [42] 0 0
Herstal
Country [43] 0 0
Belgium
State/province [43] 0 0
Kortrijk
Country [44] 0 0
Belgium
State/province [44] 0 0
Liege
Country [45] 0 0
Belgium
State/province [45] 0 0
Maldegem
Country [46] 0 0
Brazil
State/province [46] 0 0
Bahia
Country [47] 0 0
Brazil
State/province [47] 0 0
Paraná
Country [48] 0 0
Brazil
State/province [48] 0 0
Rio Grande Do Sul
Country [49] 0 0
Brazil
State/province [49] 0 0
São Paulo
Country [50] 0 0
Brazil
State/province [50] 0 0
Rio de Janeiro
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Dupnitsa
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Pleven
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Sofia
Country [54] 0 0
Canada
State/province [54] 0 0
Alberta
Country [55] 0 0
Canada
State/province [55] 0 0
British Columbia
Country [56] 0 0
Canada
State/province [56] 0 0
Manitoba
Country [57] 0 0
Canada
State/province [57] 0 0
Newfoundland and Labrador
Country [58] 0 0
Canada
State/province [58] 0 0
Ontario
Country [59] 0 0
Canada
State/province [59] 0 0
Quebec
Country [60] 0 0
Canada
State/province [60] 0 0
Saskatchewan
Country [61] 0 0
Chile
State/province [61] 0 0
Osorno
Country [62] 0 0
Chile
State/province [62] 0 0
Santiago
Country [63] 0 0
China
State/province [63] 0 0
Beijing
Country [64] 0 0
China
State/province [64] 0 0
Chongqing
Country [65] 0 0
China
State/province [65] 0 0
Fujian
Country [66] 0 0
China
State/province [66] 0 0
Guangdong
Country [67] 0 0
China
State/province [67] 0 0
Hebei
Country [68] 0 0
China
State/province [68] 0 0
Henan
Country [69] 0 0
China
State/province [69] 0 0
Hubei
Country [70] 0 0
China
State/province [70] 0 0
Hunan
Country [71] 0 0
China
State/province [71] 0 0
Jiangsu
Country [72] 0 0
China
State/province [72] 0 0
Jiangxi
Country [73] 0 0
China
State/province [73] 0 0
Jilin
Country [74] 0 0
China
State/province [74] 0 0
Liaoning
Country [75] 0 0
China
State/province [75] 0 0
Shanghai
Country [76] 0 0
China
State/province [76] 0 0
Yunnan
Country [77] 0 0
China
State/province [77] 0 0
Zhejiang
Country [78] 0 0
Croatia
State/province [78] 0 0
Ivanic-Grad
Country [79] 0 0
Croatia
State/province [79] 0 0
Zagreb
Country [80] 0 0
Czechia
State/province [80] 0 0
Kutna Hora
Country [81] 0 0
Czechia
State/province [81] 0 0
Nachod
Country [82] 0 0
Czechia
State/province [82] 0 0
Novy Jicin
Country [83] 0 0
Czechia
State/province [83] 0 0
Ostrava
Country [84] 0 0
Czechia
State/province [84] 0 0
Pardubice
Country [85] 0 0
Czechia
State/province [85] 0 0
Plzen
Country [86] 0 0
Czechia
State/province [86] 0 0
Praha 10
Country [87] 0 0
Czechia
State/province [87] 0 0
Praha 3
Country [88] 0 0
Czechia
State/province [88] 0 0
Praha 5
Country [89] 0 0
Czechia
State/province [89] 0 0
Praha 6
Country [90] 0 0
Czechia
State/province [90] 0 0
Praha 8
Country [91] 0 0
Czechia
State/province [91] 0 0
Praha
Country [92] 0 0
Czechia
State/province [92] 0 0
Svitavy
Country [93] 0 0
Czechia
State/province [93] 0 0
Usti nad Labem
Country [94] 0 0
Denmark
State/province [94] 0 0
Hellerup
Country [95] 0 0
Estonia
State/province [95] 0 0
Tallinn
Country [96] 0 0
Estonia
State/province [96] 0 0
Tartu
Country [97] 0 0
Finland
State/province [97] 0 0
Helsinki
Country [98] 0 0
Finland
State/province [98] 0 0
Oulu
Country [99] 0 0
Finland
State/province [99] 0 0
Tampere
Country [100] 0 0
France
State/province [100] 0 0
Antony
Country [101] 0 0
France
State/province [101] 0 0
Bezannes
Country [102] 0 0
France
State/province [102] 0 0
Brest
Country [103] 0 0
France
State/province [103] 0 0
Lille
Country [104] 0 0
France
State/province [104] 0 0
Lorient Cedex
Country [105] 0 0
France
State/province [105] 0 0
Martigues
Country [106] 0 0
France
State/province [106] 0 0
Nice
Country [107] 0 0
France
State/province [107] 0 0
Paris Cedex 10
Country [108] 0 0
France
State/province [108] 0 0
Rennes Cedex 9
Country [109] 0 0
France
State/province [109] 0 0
Rouen
Country [110] 0 0
Germany
State/province [110] 0 0
Bad Bentheim
Country [111] 0 0
Germany
State/province [111] 0 0
Berlin
Country [112] 0 0
Germany
State/province [112] 0 0
Bochum
Country [113] 0 0
Germany
State/province [113] 0 0
Darmstadt
Country [114] 0 0
Germany
State/province [114] 0 0
Dresden
Country [115] 0 0
Germany
State/province [115] 0 0
Frankfurt am Main
Country [116] 0 0
Germany
State/province [116] 0 0
Goettingen
Country [117] 0 0
Germany
State/province [117] 0 0
Hamburg
Country [118] 0 0
Germany
State/province [118] 0 0
Hannover
Country [119] 0 0
Germany
State/province [119] 0 0
Heidelberg
Country [120] 0 0
Germany
State/province [120] 0 0
Kiel
Country [121] 0 0
Germany
State/province [121] 0 0
Leipzig
Country [122] 0 0
Germany
State/province [122] 0 0
Mahlow
Country [123] 0 0
Germany
State/province [123] 0 0
Mainz
Country [124] 0 0
Germany
State/province [124] 0 0
Memmingen
Country [125] 0 0
Germany
State/province [125] 0 0
Merzing
Country [126] 0 0
Germany
State/province [126] 0 0
Muenchen
Country [127] 0 0
Germany
State/province [127] 0 0
Muenster
Country [128] 0 0
Germany
State/province [128] 0 0
Osnabrueck
Country [129] 0 0
Germany
State/province [129] 0 0
Remscheid
Country [130] 0 0
Germany
State/province [130] 0 0
Stuttgart
Country [131] 0 0
Germany
State/province [131] 0 0
Tuebingen
Country [132] 0 0
Germany
State/province [132] 0 0
Wuppertal
Country [133] 0 0
Greece
State/province [133] 0 0
Athens
Country [134] 0 0
Greece
State/province [134] 0 0
Ioannina
Country [135] 0 0
Greece
State/province [135] 0 0
Larissa
Country [136] 0 0
Greece
State/province [136] 0 0
Nea Ionia
Country [137] 0 0
Greece
State/province [137] 0 0
Piraeus
Country [138] 0 0
Greece
State/province [138] 0 0
Thessaloniki
Country [139] 0 0
Hong Kong
State/province [139] 0 0
Hong Kong
Country [140] 0 0
Hungary
State/province [140] 0 0
Bekescsaba
Country [141] 0 0
Hungary
State/province [141] 0 0
Budapest
Country [142] 0 0
Hungary
State/province [142] 0 0
Debrecen
Country [143] 0 0
Hungary
State/province [143] 0 0
Gyongyos
Country [144] 0 0
Hungary
State/province [144] 0 0
Kaposvar
Country [145] 0 0
Hungary
State/province [145] 0 0
Oroshaza
Country [146] 0 0
Hungary
State/province [146] 0 0
Szolnok
Country [147] 0 0
Hungary
State/province [147] 0 0
Veszprem
Country [148] 0 0
Hungary
State/province [148] 0 0
Zalaegerszeg
Country [149] 0 0
Italy
State/province [149] 0 0
Chieti
Country [150] 0 0
Italy
State/province [150] 0 0
LAquila
Country [151] 0 0
Italy
State/province [151] 0 0
Milano
Country [152] 0 0
Italy
State/province [152] 0 0
Perugia
Country [153] 0 0
Italy
State/province [153] 0 0
Roma
Country [154] 0 0
Italy
State/province [154] 0 0
Rozzano MI
Country [155] 0 0
Japan
State/province [155] 0 0
Aichi
Country [156] 0 0
Japan
State/province [156] 0 0
Chiba
Country [157] 0 0
Japan
State/province [157] 0 0
Fukuoka
Country [158] 0 0
Japan
State/province [158] 0 0
Fukushima
Country [159] 0 0
Japan
State/province [159] 0 0
Hokkaido
Country [160] 0 0
Japan
State/province [160] 0 0
Hyogo
Country [161] 0 0
Japan
State/province [161] 0 0
Ibaraki
Country [162] 0 0
Japan
State/province [162] 0 0
Ishikawa
Country [163] 0 0
Japan
State/province [163] 0 0
Iwate
Country [164] 0 0
Japan
State/province [164] 0 0
Kagawa
Country [165] 0 0
Japan
State/province [165] 0 0
Kagoshima
Country [166] 0 0
Japan
State/province [166] 0 0
Kanagawa
Country [167] 0 0
Japan
State/province [167] 0 0
Kumamoto
Country [168] 0 0
Japan
State/province [168] 0 0
Kyoto
Country [169] 0 0
Japan
State/province [169] 0 0
Nagasaki
Country [170] 0 0
Japan
State/province [170] 0 0
Osaka
Country [171] 0 0
Japan
State/province [171] 0 0
Shizuoka
Country [172] 0 0
Japan
State/province [172] 0 0
Tochigi
Country [173] 0 0
Japan
State/province [173] 0 0
Tokyo
Country [174] 0 0
Japan
State/province [174] 0 0
Toyama
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Ansansi, Gyeonggido
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Bucheon-si, Gyeonggi-do
Country [177] 0 0
Korea, Republic of
State/province [177] 0 0
Gwangju
Country [178] 0 0
Korea, Republic of
State/province [178] 0 0
Incheon
Country [179] 0 0
Korea, Republic of
State/province [179] 0 0
Seongnam-si, Gyeonggi-do
Country [180] 0 0
Korea, Republic of
State/province [180] 0 0
Seoul
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Suwon-si, Gyeonggi-do
Country [182] 0 0
Latvia
State/province [182] 0 0
Riga
Country [183] 0 0
Latvia
State/province [183] 0 0
Talsi
Country [184] 0 0
Malaysia
State/province [184] 0 0
Johor
Country [185] 0 0
Malaysia
State/province [185] 0 0
Perak
Country [186] 0 0
Malaysia
State/province [186] 0 0
Pinang
Country [187] 0 0
Malaysia
State/province [187] 0 0
Wilayah Persekutuan
Country [188] 0 0
Mexico
State/province [188] 0 0
Michoacán
Country [189] 0 0
Mexico
State/province [189] 0 0
Cuautitlán Izcalli
Country [190] 0 0
Netherlands
State/province [190] 0 0
Bergen op Zoom
Country [191] 0 0
Netherlands
State/province [191] 0 0
Groningen
Country [192] 0 0
Netherlands
State/province [192] 0 0
Utrecht
Country [193] 0 0
Poland
State/province [193] 0 0
Bialystok
Country [194] 0 0
Poland
State/province [194] 0 0
Chorzow
Country [195] 0 0
Poland
State/province [195] 0 0
Gdansk
Country [196] 0 0
Poland
State/province [196] 0 0
Katowice
Country [197] 0 0
Poland
State/province [197] 0 0
Krakow
Country [198] 0 0
Poland
State/province [198] 0 0
Lodz
Country [199] 0 0
Poland
State/province [199] 0 0
Lublin
Country [200] 0 0
Poland
State/province [200] 0 0
Malbork
Country [201] 0 0
Poland
State/province [201] 0 0
Nowa Sol
Country [202] 0 0
Poland
State/province [202] 0 0
Poznan
Country [203] 0 0
Poland
State/province [203] 0 0
Sosnowiec
Country [204] 0 0
Poland
State/province [204] 0 0
Szczecin
Country [205] 0 0
Poland
State/province [205] 0 0
Tarnow
Country [206] 0 0
Poland
State/province [206] 0 0
Warszawa
Country [207] 0 0
Poland
State/province [207] 0 0
Wroclaw
Country [208] 0 0
Portugal
State/province [208] 0 0
Almada
Country [209] 0 0
Portugal
State/province [209] 0 0
Coimbra
Country [210] 0 0
Portugal
State/province [210] 0 0
Lisboa
Country [211] 0 0
Portugal
State/province [211] 0 0
Porto
Country [212] 0 0
Romania
State/province [212] 0 0
Cluj-Napoca
Country [213] 0 0
Singapore
State/province [213] 0 0
Singapore
Country [214] 0 0
Slovakia
State/province [214] 0 0
Banska Bystrica
Country [215] 0 0
Slovakia
State/province [215] 0 0
Bardejov
Country [216] 0 0
Slovakia
State/province [216] 0 0
Bratislava
Country [217] 0 0
Slovakia
State/province [217] 0 0
Svidnik
Country [218] 0 0
Slovakia
State/province [218] 0 0
Topolcany
Country [219] 0 0
Slovenia
State/province [219] 0 0
Ljubljana
Country [220] 0 0
Slovenia
State/province [220] 0 0
Maribor
Country [221] 0 0
South Africa
State/province [221] 0 0
KwaZulu-Natal
Country [222] 0 0
Spain
State/province [222] 0 0
Andalucía
Country [223] 0 0
Spain
State/province [223] 0 0
Canarias
Country [224] 0 0
Spain
State/province [224] 0 0
Cataluña
Country [225] 0 0
Spain
State/province [225] 0 0
Comunidad Valenciana
Country [226] 0 0
Spain
State/province [226] 0 0
Galicia
Country [227] 0 0
Spain
State/province [227] 0 0
Madrid
Country [228] 0 0
Spain
State/province [228] 0 0
Navarra
Country [229] 0 0
Spain
State/province [229] 0 0
País Vasco
Country [230] 0 0
Spain
State/province [230] 0 0
Zaragoza
Country [231] 0 0
Switzerland
State/province [231] 0 0
Bern
Country [232] 0 0
Switzerland
State/province [232] 0 0
Lausanne
Country [233] 0 0
Switzerland
State/province [233] 0 0
Zuerich
Country [234] 0 0
Taiwan
State/province [234] 0 0
Kaohsiung
Country [235] 0 0
Taiwan
State/province [235] 0 0
Tainan
Country [236] 0 0
Taiwan
State/province [236] 0 0
Taipei
Country [237] 0 0
Taiwan
State/province [237] 0 0
Taoyuan
Country [238] 0 0
Thailand
State/province [238] 0 0
Bangkok
Country [239] 0 0
Turkey
State/province [239] 0 0
Ankara
Country [240] 0 0
Turkey
State/province [240] 0 0
Gaziantep
Country [241] 0 0
Turkey
State/province [241] 0 0
Istanbul
Country [242] 0 0
Turkey
State/province [242] 0 0
Izmir
Country [243] 0 0
Turkey
State/province [243] 0 0
Kayseri
Country [244] 0 0
Turkey
State/province [244] 0 0
Kocaeli
Country [245] 0 0
Turkey
State/province [245] 0 0
Samsun
Country [246] 0 0
United Kingdom
State/province [246] 0 0
London
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Salford
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Shipley

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.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?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


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/NCT05882877