Trial Review

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/NCT04524611




Registration number
NCT04524611
Ethics application status
Date submitted
20/08/2020
Date registered
24/08/2020
Date last updated
18/06/2024

Titles & IDs
Public title
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Scientific title
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Secondary ID [1] 0 0
2020-002674-26
Secondary ID [2] 0 0
M20-259
Universal Trial Number (UTN)
Trial acronym
SEQUENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

Experimental: Risankizumab Dose A Followed by Dose B - Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.

Active comparator: Ustekinumab - Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.


Treatment: Drugs: Risankizumab
Intravenous (IV) Infusion

Treatment: Drugs: Risankizumab
Subcutaneous (SC) Injection

Treatment: Drugs: Ustekinumab
Intravenous (IV) infusion

Treatment: Drugs: Ustekinumab
Subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 24
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [2] 0 0
Week 48
Primary outcome [3] 0 0
Number of Participants Reporting Adverse Events
Timepoint [3] 0 0
Up to 220 Weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Response at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Response at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving Steroid-Free Endoscopic Remission
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Percentage of Participants Achieving Steroid-Free Clinical Remission
Timepoint [5] 0 0
Week 48

Eligibility
Key inclusion criteria
* Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
* Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
* Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
* Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of ulcerative colitis or indeterminate colitis.
* Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
* Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
* Currently know complications of CD (strictures, short bowel, etc).

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2028
Actual
Sample size
Target
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Wollongong Hospital /ID# 224688 - Wollongong
Recruitment hospital [2] 0 0
Mater Misericordiae Limited /ID# 223642 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 223641 - Southport
Recruitment hospital [4] 0 0
Lyell McEwin Hospital /ID# 223643 - Elizabeth Vale
Recruitment hospital [5] 0 0
Monash Medical Centre /ID# 224599 - Clayton
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3168 - Clayton
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
West Virginia
Country [28] 0 0
Argentina
State/province [28] 0 0
Ciudad Autonoma De Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Tucuman
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Austria
State/province [31] 0 0
Niederoesterreich
Country [32] 0 0
Austria
State/province [32] 0 0
Oberoesterreich
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Belgium
State/province [34] 0 0
Bruxelles-Capitale
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
Gent
Country [40] 0 0
Belgium
State/province [40] 0 0
Liege
Country [41] 0 0
Belgium
State/province [41] 0 0
Merksem
Country [42] 0 0
Brazil
State/province [42] 0 0
La Spezia
Country [43] 0 0
Brazil
State/province [43] 0 0
Sao Paulo
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Sofia
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Plovdiv
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Nova Scotia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Canada
State/province [51] 0 0
Montreal
Country [52] 0 0
Chile
State/province [52] 0 0
Region Metropolitana De Santiago
Country [53] 0 0
Chile
State/province [53] 0 0
Concepción
Country [54] 0 0
Chile
State/province [54] 0 0
Talcahuano
Country [55] 0 0
China
State/province [55] 0 0
Anhui
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Chongqing
Country [58] 0 0
China
State/province [58] 0 0
Fujian
Country [59] 0 0
China
State/province [59] 0 0
Guangdong
Country [60] 0 0
China
State/province [60] 0 0
Henan
Country [61] 0 0
China
State/province [61] 0 0
Hubei
Country [62] 0 0
China
State/province [62] 0 0
Hunan
Country [63] 0 0
China
State/province [63] 0 0
Jiangsu
Country [64] 0 0
China
State/province [64] 0 0
Jiangxi
Country [65] 0 0
China
State/province [65] 0 0
Liaoning
Country [66] 0 0
China
State/province [66] 0 0
Shanghai
Country [67] 0 0
China
State/province [67] 0 0
Sichuan
Country [68] 0 0
China
State/province [68] 0 0
Zhejiang
Country [69] 0 0
China
State/province [69] 0 0
Changsha
Country [70] 0 0
Czechia
State/province [70] 0 0
Praha 9
Country [71] 0 0
Czechia
State/province [71] 0 0
Ceske Budejovice
Country [72] 0 0
Czechia
State/province [72] 0 0
Hradec Kralove
Country [73] 0 0
Czechia
State/province [73] 0 0
Pardubice
Country [74] 0 0
Czechia
State/province [74] 0 0
Praha
Country [75] 0 0
France
State/province [75] 0 0
Alpes-Maritimes
Country [76] 0 0
France
State/province [76] 0 0
Auvergne-Rhone-Alpes
Country [77] 0 0
France
State/province [77] 0 0
Bouches-du-Rhone
Country [78] 0 0
France
State/province [78] 0 0
Gironde
Country [79] 0 0
France
State/province [79] 0 0
Herault
Country [80] 0 0
France
State/province [80] 0 0
Ile-de-France
Country [81] 0 0
France
State/province [81] 0 0
Isere
Country [82] 0 0
France
State/province [82] 0 0
Marne
Country [83] 0 0
France
State/province [83] 0 0
Meurthe-et-Moselle
Country [84] 0 0
France
State/province [84] 0 0
Nord
Country [85] 0 0
France
State/province [85] 0 0
Pays-de-la-Loire
Country [86] 0 0
France
State/province [86] 0 0
Nantes
Country [87] 0 0
France
State/province [87] 0 0
Nimes Cedex
Country [88] 0 0
France
State/province [88] 0 0
St-Priest-en-Jarez
Country [89] 0 0
France
State/province [89] 0 0
Toulouse
Country [90] 0 0
Germany
State/province [90] 0 0
Baden-Wuerttemberg
Country [91] 0 0
Germany
State/province [91] 0 0
Bayern
Country [92] 0 0
Germany
State/province [92] 0 0
Hessen
Country [93] 0 0
Germany
State/province [93] 0 0
Nordrhein-Westfalen
Country [94] 0 0
Germany
State/province [94] 0 0
Saarland
Country [95] 0 0
Germany
State/province [95] 0 0
Sachsen
Country [96] 0 0
Germany
State/province [96] 0 0
Schleswig-Holstein
Country [97] 0 0
Germany
State/province [97] 0 0
Berlin-Zehlendorf
Country [98] 0 0
Germany
State/province [98] 0 0
Berlin
Country [99] 0 0
Germany
State/province [99] 0 0
Dresden
Country [100] 0 0
Germany
State/province [100] 0 0
Hannover
Country [101] 0 0
Germany
State/province [101] 0 0
Lueneburg
Country [102] 0 0
Germany
State/province [102] 0 0
Magdeburg
Country [103] 0 0
Germany
State/province [103] 0 0
Muenster
Country [104] 0 0
Greece
State/province [104] 0 0
Attiki
Country [105] 0 0
Greece
State/province [105] 0 0
Kriti
Country [106] 0 0
Greece
State/province [106] 0 0
Athens
Country [107] 0 0
Greece
State/province [107] 0 0
Ioannina
Country [108] 0 0
Greece
State/province [108] 0 0
Nikaia
Country [109] 0 0
Greece
State/province [109] 0 0
Thessaloniki
Country [110] 0 0
Hungary
State/province [110] 0 0
Csongrad
Country [111] 0 0
Hungary
State/province [111] 0 0
Hajdu-Bihar
Country [112] 0 0
Hungary
State/province [112] 0 0
Tolna
Country [113] 0 0
Hungary
State/province [113] 0 0
Budapest
Country [114] 0 0
Israel
State/province [114] 0 0
HaDarom
Country [115] 0 0
Israel
State/province [115] 0 0
HaMerkaz
Country [116] 0 0
Israel
State/province [116] 0 0
Tel-Aviv
Country [117] 0 0
Israel
State/province [117] 0 0
Yerushalayim
Country [118] 0 0
Israel
State/province [118] 0 0
Haifa
Country [119] 0 0
Italy
State/province [119] 0 0
Genova
Country [120] 0 0
Italy
State/province [120] 0 0
Milano
Country [121] 0 0
Italy
State/province [121] 0 0
Roma
Country [122] 0 0
Italy
State/province [122] 0 0
Verona
Country [123] 0 0
Italy
State/province [123] 0 0
Bologna
Country [124] 0 0
Italy
State/province [124] 0 0
Cagliari
Country [125] 0 0
Italy
State/province [125] 0 0
Milan
Country [126] 0 0
Italy
State/province [126] 0 0
Palermo
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Daejeon Gwang Yeogsi
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Gyeongsangnamdo
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Seoul Teugbyeolsi
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Seoul
Country [131] 0 0
Mexico
State/province [131] 0 0
Baja California
Country [132] 0 0
Mexico
State/province [132] 0 0
Jalisco
Country [133] 0 0
Mexico
State/province [133] 0 0
Nuevo Leon
Country [134] 0 0
Mexico
State/province [134] 0 0
Yucatan
Country [135] 0 0
Mexico
State/province [135] 0 0
Veracruz
Country [136] 0 0
Netherlands
State/province [136] 0 0
Gelderland
Country [137] 0 0
Netherlands
State/province [137] 0 0
Noord-Holland
Country [138] 0 0
Netherlands
State/province [138] 0 0
Tilburg
Country [139] 0 0
Netherlands
State/province [139] 0 0
Utrecht
Country [140] 0 0
Poland
State/province [140] 0 0
Kujawsko-pomorskie
Country [141] 0 0
Poland
State/province [141] 0 0
Malopolskie
Country [142] 0 0
Poland
State/province [142] 0 0
Mazowieckie
Country [143] 0 0
Romania
State/province [143] 0 0
Bucuresti
Country [144] 0 0
Romania
State/province [144] 0 0
Bucharest
Country [145] 0 0
Romania
State/province [145] 0 0
Targu Mures
Country [146] 0 0
Romania
State/province [146] 0 0
Timi?oara
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Kaliningradskaya Oblast
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Moscow
Country [149] 0 0
Russian Federation
State/province [149] 0 0
St. Petersburg
Country [150] 0 0
Slovakia
State/province [150] 0 0
Nitriansky Kraj
Country [151] 0 0
Slovakia
State/province [151] 0 0
Presovsky Kraj
Country [152] 0 0
Slovakia
State/province [152] 0 0
Banska Bystrica
Country [153] 0 0
Slovakia
State/province [153] 0 0
Nove Zamky
Country [154] 0 0
South Africa
State/province [154] 0 0
Gauteng
Country [155] 0 0
South Africa
State/province [155] 0 0
Western Cape
Country [156] 0 0
Spain
State/province [156] 0 0
A Coruna
Country [157] 0 0
Spain
State/province [157] 0 0
Asturias
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Madrid
Country [160] 0 0
Spain
State/province [160] 0 0
Alicante
Country [161] 0 0
Spain
State/province [161] 0 0
Sevilla
Country [162] 0 0
Spain
State/province [162] 0 0
Valencia
Country [163] 0 0
Sweden
State/province [163] 0 0
Stockholms Lan
Country [164] 0 0
Sweden
State/province [164] 0 0
Falun
Country [165] 0 0
Sweden
State/province [165] 0 0
Stockholm
Country [166] 0 0
Switzerland
State/province [166] 0 0
Basel-Stadt
Country [167] 0 0
Switzerland
State/province [167] 0 0
Zuerich
Country [168] 0 0
Switzerland
State/province [168] 0 0
Bern
Country [169] 0 0
Turkey
State/province [169] 0 0
Ankara
Country [170] 0 0
Turkey
State/province [170] 0 0
Istanbul
Country [171] 0 0
Turkey
State/province [171] 0 0
Mersin
Country [172] 0 0
Ukraine
State/province [172] 0 0
Kyiv
Country [173] 0 0
Ukraine
State/province [173] 0 0
Lviv
Country [174] 0 0
Ukraine
State/province [174] 0 0
Zaporizhzhia
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Cambridgeshire
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Devon
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Hampshire
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Hertfordshire
Country [179] 0 0
United Kingdom
State/province [179] 0 0
London, City Of
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Nottinghamshire
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Oxfordshire
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Scotland
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Belfast
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Edinburgh
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Huddersfield
Country [186] 0 0
United Kingdom
State/province [186] 0 0
London
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Newcastle upon Tyne
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Salford
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Stirling
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Tooting

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

Ethics approval
Ethics application status

Summary
Brief summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT04524611
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04524611