Trial Review

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/ct2/show/NCT03105102




Registration number
NCT03105102
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
3/03/2023

Titles & IDs
Public title
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2016-003191-50
Secondary ID [2] 0 0
M16-000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo for Risankizumab SC
Treatment: Drugs - Risankizumab IV
Treatment: Drugs - Placebo for Risankizumab IV
Treatment: Drugs - Risankizumab SC
Treatment: Drugs - Risankizumab On-Body Injector (OBI)

Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1) - Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.

Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.

Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.

Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2) - Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2) - Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Open-label Risankizumab (Sub-Study 3) - Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.

Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4) - Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.

Experimental: CTE: Open Label Continuous Treatment Extension - Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.


Treatment: Drugs: Placebo for Risankizumab SC
Placebo for Risankizumab SC Subcutaneous (SC) Injection

Treatment: Drugs: Risankizumab IV
Risankizumab IV Intravenous (IV) infusion

Treatment: Drugs: Placebo for Risankizumab IV
Placebo for Risankizumab IV Intravenous (IV) infusion

Treatment: Drugs: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection

Treatment: Drugs: Risankizumab On-Body Injector (OBI)
Subcutaneous (SC) injection; on-body injector (OBI)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Sub-Study 1: Percentage of Participants With Endoscopic Response
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Sub-Study 3: Number of Participants With Adverse Events
Timepoint [3] 0 0
Up to Week 220
Primary outcome [4] 0 0
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
Timepoint [4] 0 0
Up to Week 16
Primary outcome [5] 0 0
Sub-Study 4: Percentage of Participants who had no Potential Hazards
Timepoint [5] 0 0
Up to Week 16
Primary outcome [6] 0 0
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
Timepoint [6] 0 0
Up to Week 16
Primary outcome [7] 0 0
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Timepoint [7] 0 0
Up to Week 16
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants With Clinical Remission
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Percentage of Participants With Deep Remission
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Timepoint [12] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
- Participants who have entered and completed Study M16-006 or Study M15-991 or other
AbbVie risankizumab Crohn's disease study.

- Participants have completed the study M16-006 or M15-991 and have achieved clinical
response.

- Sub-Study 4:

- Participants receiving maintenance treatment in Sub-study 3 and willing to comply
with the requirements of Sub-study 4, including self-administration of
sub-cutaneous injections using the on-body injector (OBI).

- Participant has received at least 16 weeks of stable dosing with risankizumab in
Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the
72-week mark).
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia
or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie
risankizumab Crohn's disease study if the final endoscopy was performed prior to enter
Study M16-000 OR is considered by the Investigator, for any reason, to be an
unsuitable candidate for the study.

- Participant who has a known hypersensitivity to risankizumab or the excipients of any
of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an
adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab
Crohn's disease study that in the Investigator's judgment makes the participant
unsuitable for this study.

- Participant is not in compliance with prior and concomitant medication requirements
throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease
study.

- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study
M15-991 or another AbbVie risankizumab Crohn's disease study.

- Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
and/or splenomegaly.

- Any active or chronic recurring infections based on the Investigator's assessment
makes the participant an unsuitable candidate for the study.

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 administering the treatment/s
The people assessing the outcomes
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/06/2026
Actual
Sample size
Target
Accrual to date
Final
1336
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Limited /ID# 167220 - South Brisbane
Recruitment hospital [2] 0 0
Griffith University /ID# 212635 - Southport
Recruitment hospital [3] 0 0
Lyell McEwin Hospital /ID# 212215 - Elizabeth Vale
Recruitment hospital [4] 0 0
Emeritus Research /ID# 213512 - Camberwell
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4222 - Southport
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
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
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
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
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciuadad Autonoma De Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Austria
State/province [35] 0 0
Niederoesterreich
Country [36] 0 0
Austria
State/province [36] 0 0
Steiermark
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Belarus
State/province [38] 0 0
Gomel
Country [39] 0 0
Belarus
State/province [39] 0 0
Grodno
Country [40] 0 0
Belarus
State/province [40] 0 0
???????
Country [41] 0 0
Belgium
State/province [41] 0 0
Antwerpen
Country [42] 0 0
Belgium
State/province [42] 0 0
Bruxelles-Capitale
Country [43] 0 0
Belgium
State/province [43] 0 0
Namur
Country [44] 0 0
Belgium
State/province [44] 0 0
Oost-Vlaanderen
Country [45] 0 0
Belgium
State/province [45] 0 0
Vlaams-Brabant
Country [46] 0 0
Belgium
State/province [46] 0 0
West-Vlaanderen
Country [47] 0 0
Belgium
State/province [47] 0 0
Bonheiden
Country [48] 0 0
Belgium
State/province [48] 0 0
Gent
Country [49] 0 0
Belgium
State/province [49] 0 0
Kortrijk
Country [50] 0 0
Belgium
State/province [50] 0 0
Liege
Country [51] 0 0
Belgium
State/province [51] 0 0
Merksem
Country [52] 0 0
Bosnia and Herzegovina
State/province [52] 0 0
Republika Srpska
Country [53] 0 0
Bosnia and Herzegovina
State/province [53] 0 0
Sarajevo
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Pleven
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Plovdiv
Country [56] 0 0
Bulgaria
State/province [56] 0 0
Sofia
Country [57] 0 0
Bulgaria
State/province [57] 0 0
Stara Zagora
Country [58] 0 0
Canada
State/province [58] 0 0
Alberta
Country [59] 0 0
Canada
State/province [59] 0 0
British Columbia
Country [60] 0 0
Canada
State/province [60] 0 0
Nova Scotia
Country [61] 0 0
Canada
State/province [61] 0 0
Ontario
Country [62] 0 0
Canada
State/province [62] 0 0
Quebec
Country [63] 0 0
Chile
State/province [63] 0 0
Region Metropolitana Santiago
Country [64] 0 0
Chile
State/province [64] 0 0
Concepción
Country [65] 0 0
Chile
State/province [65] 0 0
Talcahuano
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
Hubei
Country [69] 0 0
China
State/province [69] 0 0
Jiangxi
Country [70] 0 0
China
State/province [70] 0 0
Shanghai
Country [71] 0 0
China
State/province [71] 0 0
Sichuan
Country [72] 0 0
China
State/province [72] 0 0
Zhejiang
Country [73] 0 0
China
State/province [73] 0 0
Changsha
Country [74] 0 0
China
State/province [74] 0 0
Tianjin
Country [75] 0 0
Colombia
State/province [75] 0 0
Antioquia
Country [76] 0 0
Colombia
State/province [76] 0 0
Cundinamarca
Country [77] 0 0
Colombia
State/province [77] 0 0
Medellin
Country [78] 0 0
Croatia
State/province [78] 0 0
Grad Zagreb
Country [79] 0 0
Croatia
State/province [79] 0 0
Osjecko-baranjska Zupanija
Country [80] 0 0
Croatia
State/province [80] 0 0
Splitsko-dalmatinska Zupanija
Country [81] 0 0
Croatia
State/province [81] 0 0
Zadar
Country [82] 0 0
Czechia
State/province [82] 0 0
Praha 4
Country [83] 0 0
Czechia
State/province [83] 0 0
Hradec Kralove
Country [84] 0 0
Czechia
State/province [84] 0 0
Pardubice
Country [85] 0 0
Czechia
State/province [85] 0 0
Praha
Country [86] 0 0
Denmark
State/province [86] 0 0
Hovedstaden
Country [87] 0 0
Denmark
State/province [87] 0 0
Midtjylland
Country [88] 0 0
Denmark
State/province [88] 0 0
Sjælland
Country [89] 0 0
Denmark
State/province [89] 0 0
Syddanmark
Country [90] 0 0
Egypt
State/province [90] 0 0
Al Sharqia
Country [91] 0 0
Egypt
State/province [91] 0 0
Alexandria
Country [92] 0 0
Egypt
State/province [92] 0 0
Cairo
Country [93] 0 0
Estonia
State/province [93] 0 0
Harjumaa
Country [94] 0 0
Estonia
State/province [94] 0 0
Tallinn
Country [95] 0 0
France
State/province [95] 0 0
Alpes-Maritimes
Country [96] 0 0
France
State/province [96] 0 0
Auvergne-Rhone-Alpes
Country [97] 0 0
France
State/province [97] 0 0
Gironde
Country [98] 0 0
France
State/province [98] 0 0
Hauts-de-France
Country [99] 0 0
France
State/province [99] 0 0
Herault
Country [100] 0 0
France
State/province [100] 0 0
Ile-de-France
Country [101] 0 0
France
State/province [101] 0 0
Loire
Country [102] 0 0
France
State/province [102] 0 0
Meurthe-et-Moselle
Country [103] 0 0
France
State/province [103] 0 0
Somme
Country [104] 0 0
France
State/province [104] 0 0
La Tronche
Country [105] 0 0
France
State/province [105] 0 0
Rennes
Country [106] 0 0
Germany
State/province [106] 0 0
Baden-Wuerttemberg
Country [107] 0 0
Germany
State/province [107] 0 0
Bayern
Country [108] 0 0
Germany
State/province [108] 0 0
Hessen
Country [109] 0 0
Germany
State/province [109] 0 0
Niedersachsen
Country [110] 0 0
Germany
State/province [110] 0 0
Nordrhein-Westfalen
Country [111] 0 0
Germany
State/province [111] 0 0
Saarland
Country [112] 0 0
Germany
State/province [112] 0 0
Schleswig-Holstein
Country [113] 0 0
Germany
State/province [113] 0 0
Thueringen
Country [114] 0 0
Germany
State/province [114] 0 0
Berlin-Zehlendorf
Country [115] 0 0
Germany
State/province [115] 0 0
Berlin
Country [116] 0 0
Germany
State/province [116] 0 0
Braunschweig
Country [117] 0 0
Germany
State/province [117] 0 0
Dachau
Country [118] 0 0
Germany
State/province [118] 0 0
Frankfurt am Main
Country [119] 0 0
Germany
State/province [119] 0 0
Hannover
Country [120] 0 0
Germany
State/province [120] 0 0
Leipzig
Country [121] 0 0
Germany
State/province [121] 0 0
Lueneburg
Country [122] 0 0
Germany
State/province [122] 0 0
Magdeburg
Country [123] 0 0
Germany
State/province [123] 0 0
Minden
Country [124] 0 0
Germany
State/province [124] 0 0
Regensburg
Country [125] 0 0
Greece
State/province [125] 0 0
Attiki
Country [126] 0 0
Greece
State/province [126] 0 0
Kriti
Country [127] 0 0
Greece
State/province [127] 0 0
Athens
Country [128] 0 0
Greece
State/province [128] 0 0
Ioannina
Country [129] 0 0
Greece
State/province [129] 0 0
Pireaus
Country [130] 0 0
Greece
State/province [130] 0 0
Thessaloniki
Country [131] 0 0
Hong Kong
State/province [131] 0 0
Hong Kong
Country [132] 0 0
Ireland
State/province [132] 0 0
Dublin
Country [133] 0 0
Ireland
State/province [133] 0 0
Galway
Country [134] 0 0
Israel
State/province [134] 0 0
HaDarom
Country [135] 0 0
Israel
State/province [135] 0 0
Tel-Aviv
Country [136] 0 0
Israel
State/province [136] 0 0
Yerushalayim
Country [137] 0 0
Israel
State/province [137] 0 0
Haifa
Country [138] 0 0
Israel
State/province [138] 0 0
Holon
Country [139] 0 0
Israel
State/province [139] 0 0
Jerusalem
Country [140] 0 0
Italy
State/province [140] 0 0
Ancona
Country [141] 0 0
Italy
State/province [141] 0 0
Calabria
Country [142] 0 0
Italy
State/province [142] 0 0
Emilia-Romagna
Country [143] 0 0
Italy
State/province [143] 0 0
Genova
Country [144] 0 0
Italy
State/province [144] 0 0
Lazio
Country [145] 0 0
Italy
State/province [145] 0 0
Milano
Country [146] 0 0
Italy
State/province [146] 0 0
Roma
Country [147] 0 0
Italy
State/province [147] 0 0
Toscana
Country [148] 0 0
Italy
State/province [148] 0 0
Verona
Country [149] 0 0
Italy
State/province [149] 0 0
Bologna
Country [150] 0 0
Italy
State/province [150] 0 0
Catania
Country [151] 0 0
Italy
State/province [151] 0 0
Milan
Country [152] 0 0
Italy
State/province [152] 0 0
Palermo
Country [153] 0 0
Italy
State/province [153] 0 0
Pavia
Country [154] 0 0
Japan
State/province [154] 0 0
Aichi
Country [155] 0 0
Japan
State/province [155] 0 0
Chiba
Country [156] 0 0
Japan
State/province [156] 0 0
Fukuoka
Country [157] 0 0
Japan
State/province [157] 0 0
Hiroshima
Country [158] 0 0
Japan
State/province [158] 0 0
Hokkaido
Country [159] 0 0
Japan
State/province [159] 0 0
Hyogo
Country [160] 0 0
Japan
State/province [160] 0 0
Ibaraki
Country [161] 0 0
Japan
State/province [161] 0 0
Ishikawa
Country [162] 0 0
Japan
State/province [162] 0 0
Kanagawa
Country [163] 0 0
Japan
State/province [163] 0 0
Mie
Country [164] 0 0
Japan
State/province [164] 0 0
Miyagi
Country [165] 0 0
Japan
State/province [165] 0 0
Osaka
Country [166] 0 0
Japan
State/province [166] 0 0
Saitama
Country [167] 0 0
Japan
State/province [167] 0 0
Shiga
Country [168] 0 0
Japan
State/province [168] 0 0
Shizuoka
Country [169] 0 0
Japan
State/province [169] 0 0
Tokyo
Country [170] 0 0
Japan
State/province [170] 0 0
Wakayama
Country [171] 0 0
Japan
State/province [171] 0 0
Yamagata
Country [172] 0 0
Japan
State/province [172] 0 0
Yamanashi
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Gyeonggido
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Seoul Teugbyeolsi
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Busan
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Daegu
Country [177] 0 0
Korea, Republic of
State/province [177] 0 0
Daejeon
Country [178] 0 0
Korea, Republic of
State/province [178] 0 0
Seoul
Country [179] 0 0
Latvia
State/province [179] 0 0
Riga
Country [180] 0 0
Lithuania
State/province [180] 0 0
Kaunas
Country [181] 0 0
Lithuania
State/province [181] 0 0
Vilnius
Country [182] 0 0
Malaysia
State/province [182] 0 0
Sabah
Country [183] 0 0
Malaysia
State/province [183] 0 0
Selangor
Country [184] 0 0
Malaysia
State/province [184] 0 0
Kelantan
Country [185] 0 0
Mexico
State/province [185] 0 0
Jalisco
Country [186] 0 0
Mexico
State/province [186] 0 0
Morelos
Country [187] 0 0
Mexico
State/province [187] 0 0
Yucatan
Country [188] 0 0
Mexico
State/province [188] 0 0
Del. Benito Juárez
Country [189] 0 0
Netherlands
State/province [189] 0 0
Amsterdam
Country [190] 0 0
Netherlands
State/province [190] 0 0
Tilburg
Country [191] 0 0
New Zealand
State/province [191] 0 0
Auckland
Country [192] 0 0
New Zealand
State/province [192] 0 0
Canterbury
Country [193] 0 0
New Zealand
State/province [193] 0 0
Otago
Country [194] 0 0
New Zealand
State/province [194] 0 0
Wellington
Country [195] 0 0
Norway
State/province [195] 0 0
Akershus
Country [196] 0 0
Norway
State/province [196] 0 0
Gjettum
Country [197] 0 0
Norway
State/province [197] 0 0
Levanger
Country [198] 0 0
Norway
State/province [198] 0 0
Ålesund
Country [199] 0 0
Poland
State/province [199] 0 0
Dolnoslaskie
Country [200] 0 0
Poland
State/province [200] 0 0
Kujawsko-pomorskie
Country [201] 0 0
Poland
State/province [201] 0 0
Lodzkie
Country [202] 0 0
Poland
State/province [202] 0 0
Lubelskie
Country [203] 0 0
Poland
State/province [203] 0 0
Mazowieckie
Country [204] 0 0
Poland
State/province [204] 0 0
Podkarpackie
Country [205] 0 0
Poland
State/province [205] 0 0
Pomorskie
Country [206] 0 0
Poland
State/province [206] 0 0
Slaskie
Country [207] 0 0
Poland
State/province [207] 0 0
Warminsko-mazurskie
Country [208] 0 0
Poland
State/province [208] 0 0
Wielkopolskie
Country [209] 0 0
Poland
State/province [209] 0 0
Wroclaw
Country [210] 0 0
Portugal
State/province [210] 0 0
Braga
Country [211] 0 0
Portugal
State/province [211] 0 0
Faro
Country [212] 0 0
Portugal
State/province [212] 0 0
Porto
Country [213] 0 0
Portugal
State/province [213] 0 0
Almada
Country [214] 0 0
Portugal
State/province [214] 0 0
Lisboa
Country [215] 0 0
Portugal
State/province [215] 0 0
Loures
Country [216] 0 0
Portugal
State/province [216] 0 0
Viseu
Country [217] 0 0
Romania
State/province [217] 0 0
Bucharest
Country [218] 0 0
Romania
State/province [218] 0 0
Cluj
Country [219] 0 0
Romania
State/province [219] 0 0
Timisoara
Country [220] 0 0
Romania
State/province [220] 0 0
Timi?oara
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Kemerovskaya Oblast
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Permskiy Kray
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Sankt-Peterburg
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Stavropol Skiy Kray
Country [225] 0 0
Russian Federation
State/province [225] 0 0
Tverskaya Oblast
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Tyumenskaya Oblast
Country [227] 0 0
Russian Federation
State/province [227] 0 0
Udmurtskaya Respublika
Country [228] 0 0
Russian Federation
State/province [228] 0 0
Moscow
Country [229] 0 0
Russian Federation
State/province [229] 0 0
Novosibirsk
Country [230] 0 0
Russian Federation
State/province [230] 0 0
St. Petersburg
Country [231] 0 0
Russian Federation
State/province [231] 0 0
Ulyanovsk
Country [232] 0 0
Serbia
State/province [232] 0 0
Beograd
Country [233] 0 0
Serbia
State/province [233] 0 0
Sumadijski Okrug
Country [234] 0 0
Serbia
State/province [234] 0 0
Vojvodina
Country [235] 0 0
Serbia
State/province [235] 0 0
Belgrade
Country [236] 0 0
Serbia
State/province [236] 0 0
Leskovac
Country [237] 0 0
Singapore
State/province [237] 0 0
Singapore
Country [238] 0 0
Slovakia
State/province [238] 0 0
Banska Bystrica
Country [239] 0 0
Slovakia
State/province [239] 0 0
Nitra
Country [240] 0 0
Slovakia
State/province [240] 0 0
Presov
Country [241] 0 0
South Africa
State/province [241] 0 0
Gauteng
Country [242] 0 0
South Africa
State/province [242] 0 0
Western Cape
Country [243] 0 0
Spain
State/province [243] 0 0
A Coruna
Country [244] 0 0
Spain
State/province [244] 0 0
Barcelona
Country [245] 0 0
Spain
State/province [245] 0 0
Madrid
Country [246] 0 0
Spain
State/province [246] 0 0
Vizcaya
Country [247] 0 0
Spain
State/province [247] 0 0
Salamanca
Country [248] 0 0
Spain
State/province [248] 0 0
Sevilla
Country [249] 0 0
Spain
State/province [249] 0 0
Valencia
Country [250] 0 0
Spain
State/province [250] 0 0
Zaragoza
Country [251] 0 0
Sweden
State/province [251] 0 0
Skane Lan
Country [252] 0 0
Sweden
State/province [252] 0 0
Stockholms Lan
Country [253] 0 0
Sweden
State/province [253] 0 0
Vastra Gotalands Lan
Country [254] 0 0
Sweden
State/province [254] 0 0
Stockholm
Country [255] 0 0
Switzerland
State/province [255] 0 0
Basel-Stadt
Country [256] 0 0
Switzerland
State/province [256] 0 0
Zuerich
Country [257] 0 0
Switzerland
State/province [257] 0 0
Bern
Country [258] 0 0
Taiwan
State/province [258] 0 0
Taichung City
Country [259] 0 0
Taiwan
State/province [259] 0 0
Taichung
Country [260] 0 0
Taiwan
State/province [260] 0 0
Tainan
Country [261] 0 0
Taiwan
State/province [261] 0 0
Taipei City
Country [262] 0 0
Ukraine
State/province [262] 0 0
Kharkiv
Country [263] 0 0
Ukraine
State/province [263] 0 0
Kherson
Country [264] 0 0
Ukraine
State/province [264] 0 0
Kyiv
Country [265] 0 0
Ukraine
State/province [265] 0 0
Lutsk
Country [266] 0 0
Ukraine
State/province [266] 0 0
Lviv
Country [267] 0 0
Ukraine
State/province [267] 0 0
Uzhgorod
Country [268] 0 0
Ukraine
State/province [268] 0 0
Vinnytsia
Country [269] 0 0
United Kingdom
State/province [269] 0 0
Devon
Country [270] 0 0
United Kingdom
State/province [270] 0 0
East Riding Of Yorkshire
Country [271] 0 0
United Kingdom
State/province [271] 0 0
London, City Of
Country [272] 0 0
United Kingdom
State/province [272] 0 0
Oxfordshire
Country [273] 0 0
United Kingdom
State/province [273] 0 0
Scotland
Country [274] 0 0
United Kingdom
State/province [274] 0 0
Surrey
Country [275] 0 0
United Kingdom
State/province [275] 0 0
Barnsley
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Birmingham
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Cambridge
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Edinburgh
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Huddersfield
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Leeds
Country [281] 0 0
United Kingdom
State/province [281] 0 0
London
Country [282] 0 0
United Kingdom
State/province [282] 0 0
Newcastle upon Tyne
Country [283] 0 0
United Kingdom
State/province [283] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
The study consists of 4 sub-studies, as follows:

- Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the
efficacy and safety of risankizumab versus placebo as maintenance therapy in
participants with moderately to severely active Crohn's disease (CD) who responded to
intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;

- Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and
safety of two different dosing regimens for risankizumab as maintenance therapy in
participants who responded to induction treatment in Study M16-006 or Study M15-991;

- Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of
risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie
risankizumab Crohn's disease study, or participants who responded to induction treatment
in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.
Additional objectives are to further investigate long-term efficacy and tolerability of
risankizumab;

- Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension
study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and
pharmacokinetics of risankizumab administered via OBI in participants who are receiving
maintenance treatment with risankizumab.

- OL CTE to ensure uninterrupted care in accordance with local regulations until
risankizumab is commercially available for participants who completed Sub-study 3,
Sub-study 4.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03105102
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/ct2/show/NCT03105102