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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03398148




Registration number
NCT03398148
Ethics application status
Date submitted
8/01/2018
Date registered
12/01/2018
Date last updated
1/08/2023

Titles & IDs
Public title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2016-004677-40
Secondary ID [2] 0 0
M16-067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - risankizumab IV
Treatment: Drugs - placebo for risankizumab
Treatment: Drugs - risankizumab SC

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3 - Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.

Placebo comparator: Substudy 1, Induction 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 1: Open-label Risankizumab Dose 1 - Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a) - Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b) - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Placebo comparator: Substudy 2, Induction 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a) - Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b) - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.


Treatment: Drugs: risankizumab IV
risankizumab intravenous (IV) infusion

Treatment: Drugs: placebo for risankizumab
placebo for risankizumab

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

Outcomes
Primary outcome [1] 0 0
Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants with Hospitalization
Timepoint [6] 0 0
Through Week 12
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
Timepoint [8] 0 0
Baseline Through Week 12
Secondary outcome [9] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [9] 0 0
Baseline Through Week 12
Secondary outcome [10] 0 0
Sub-Study 1: Change in Short Form-36 (SF-36)
Timepoint [10] 0 0
Baseline Through Week 12
Secondary outcome [11] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [11] 0 0
Baseline Through Week 12
Secondary outcome [12] 0 0
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries
Timepoint [12] 0 0
Through Week 12
Secondary outcome [13] 0 0
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4
Timepoint [17] 0 0
Week 4
Secondary outcome [18] 0 0
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
Timepoint [18] 0 0
Week 12
Secondary outcome [19] 0 0
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
Timepoint [20] 0 0
Week 12
Secondary outcome [21] 0 0
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [21] 0 0
Baseline to Week 12
Secondary outcome [22] 0 0
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
Timepoint [22] 0 0
Baseline to Week 12
Secondary outcome [23] 0 0
Sub-Study 2: Occurrence of UC-related Hospitalizations
Timepoint [23] 0 0
Baseline Through Week 12
Secondary outcome [24] 0 0
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Timepoint [24] 0 0
Week 12
Secondary outcome [25] 0 0
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Timepoint [25] 0 0
Week 12
Secondary outcome [26] 0 0
Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week
Timepoint [26] 0 0
Baseline to Week 12
Secondary outcome [27] 0 0
Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
Timepoint [27] 0 0
Baseline to Week 12

Eligibility
Key inclusion criteria
* Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
* Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
* Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
* Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
* Participant receiving prohibited medications and treatment.
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
* Participant with currently known complications of UC (e.g., megacolon).
* No known active Coronavirus Disease - 2019 (COVID-19) infection.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/05/2023
Sample size
Target
Accrual to date
Final
1558
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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Kentucky
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Louisiana
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Michigan
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Nebraska
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North Carolina
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South Carolina
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Tennessee
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Virginia
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Washington
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Argentina
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Ciuadad Autonoma De Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Cordoba
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Niederoesterreich
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Steiermark
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Wien
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Jilin
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Shanghai
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Sichuan
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China
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Zhejiang
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China
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Changsha
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Shenyang
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China
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Wuhan
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Colombia
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Cordoba
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Colombia
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Medellin
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Croatia
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Grad Zagreb
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Croatia
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Osjecko-baranjska Zupanija
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Croatia
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Splitsko-dalmatinska Zupanija
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Czechia
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Brno
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Czechia
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Ceske Budejovice
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Hradec Kralove
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Czechia
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Ostrava
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Hovedstaden
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Sjælland
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Denmark
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Syddanmark
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Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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Menoufiya
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Alpes-Maritimes
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France
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Bouches-du-Rhone
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Gironde
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France
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Herault
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Ile-de-France
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France
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Loire
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France
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Meurthe-et-Moselle
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France
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Somme
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France
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Nantes
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Braunschweig
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Germany
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Frankfurt am Main
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Germany
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Kassel
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Germany
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Leipzig
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Germany
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Lueneburg
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Germany
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Minden
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Germany
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München
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Germany
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Regensburg
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Greece
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Attiki
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Greece
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Kriti
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Greece
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Athens
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Greece
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Pireaus
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Greece
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Thessaloniki
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Israel
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HaDarom
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Israel
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Tel-Aviv
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Israel
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Yerushalayim
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petakh Tikva
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Italy
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Calabria
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Italy
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Emilia-Romagna
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Italy
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Genova
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Italy
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Lazio
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Italy
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Milano
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Italy
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Roma
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Italy
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Verona
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Italy
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Catania
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Italy
State/province [129] 0 0
Modena
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Italy
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Rome
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Nagasaki
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saga
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Japan
State/province [149] 0 0
Saitama
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Japan
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Shiga
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Japan
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Yamagata
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Japan
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Yamaguchi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kelantan
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Mexico
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Morelos
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Mexico
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Yucatan
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Mexico
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Del. Benito Juárez
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Netherlands
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Amsterdam
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Netherlands
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Tilburg
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New Zealand
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Bay Of Plenty
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New Zealand
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Canterbury
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New Zealand
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Waikato
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New Zealand
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Wellington
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New Zealand
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Lower Hutt
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New Zealand
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Otago
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Poland
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Dolnoslaskie
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Tooting

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

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Trial website
https://clinicaltrials.gov/study/NCT03398148
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/NCT03398148