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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03398135




Registration number
NCT03398135
Ethics application status
Date submitted
8/01/2018
Date registered
12/01/2018

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
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 Ulcerative Colitis
Secondary ID [1] 0 0
2016-004676-22
Secondary ID [2] 0 0
M16-066
Universal Trial Number (UTN)
Trial acronym
COMMAND
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
Treatment: Drugs - placebo for risankizumab

Placebo comparator: Substudy 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.

Experimental: Substudy 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Experimental: Substudy 1: Double-blind Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Experimental: Substudy 3: OL Extension Risankizumab - Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.

Experimental: OL Continuous Treatment Extension - Dose 1 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.

Experimental: OL Continuous Treatment Extension - Dose 2 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.


Treatment: Drugs: risankizumab
subcutaneous (SC) injection

Treatment: Drugs: placebo for 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: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of Participants with Adverse Events (AE)
Timepoint [2] 0 0
Up to Week 300
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [11] 0 0
Week 0 to Week 52
Secondary outcome [12] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [12] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [13] 0 0
Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Sub-Study 1: Percentage of Participants Achieving No Tenesmus
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week
Timepoint [15] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [16] 0 0
Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
Timepoint [16] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [17] 0 0
Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization
Timepoint [17] 0 0
Through Week 52

Eligibility
Key inclusion criteria
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who have 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 M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

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 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
28/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2028
Actual
Sample size
Target
Accrual to date
Final
1242
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Moscow
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Serbia
State/province [206] 0 0
Beograd
Country [207] 0 0
Serbia
State/province [207] 0 0
Pomoravski Okrug
Country [208] 0 0
Serbia
State/province [208] 0 0
Vojvodina
Country [209] 0 0
Singapore
State/province [209] 0 0
Singapore
Country [210] 0 0
Slovakia
State/province [210] 0 0
Bratislavsky Kraj
Country [211] 0 0
Slovakia
State/province [211] 0 0
Nitriansky Kraj
Country [212] 0 0
Slovakia
State/province [212] 0 0
Presovsky Kraj
Country [213] 0 0
Slovenia
State/province [213] 0 0
Ljubljana
Country [214] 0 0
South Africa
State/province [214] 0 0
Free State
Country [215] 0 0
South Africa
State/province [215] 0 0
Gauteng
Country [216] 0 0
South Africa
State/province [216] 0 0
Western Cape
Country [217] 0 0
Spain
State/province [217] 0 0
A Coruna
Country [218] 0 0
Spain
State/province [218] 0 0
Asturias
Country [219] 0 0
Spain
State/province [219] 0 0
Barcelona
Country [220] 0 0
Spain
State/province [220] 0 0
Madrid
Country [221] 0 0
Spain
State/province [221] 0 0
Pontevedra
Country [222] 0 0
Spain
State/province [222] 0 0
Cordoba
Country [223] 0 0
Spain
State/province [223] 0 0
Salamanca
Country [224] 0 0
Spain
State/province [224] 0 0
Sevilla
Country [225] 0 0
Spain
State/province [225] 0 0
Zaragoza
Country [226] 0 0
Sweden
State/province [226] 0 0
Vastra Gotalands Lan
Country [227] 0 0
Sweden
State/province [227] 0 0
Stockholm
Country [228] 0 0
Switzerland
State/province [228] 0 0
Zuerich
Country [229] 0 0
Switzerland
State/province [229] 0 0
Bern
Country [230] 0 0
Taiwan
State/province [230] 0 0
Keelung
Country [231] 0 0
Taiwan
State/province [231] 0 0
Taipei
Country [232] 0 0
Taiwan
State/province [232] 0 0
Taichung
Country [233] 0 0
Taiwan
State/province [233] 0 0
Taoyuan City
Country [234] 0 0
Turkey
State/province [234] 0 0
Istanbul
Country [235] 0 0
Turkey
State/province [235] 0 0
Kayseri
Country [236] 0 0
Turkey
State/province [236] 0 0
Ankara
Country [237] 0 0
Turkey
State/province [237] 0 0
Battalgazi/malatya
Country [238] 0 0
Turkey
State/province [238] 0 0
Bursa
Country [239] 0 0
Turkey
State/province [239] 0 0
Elazig
Country [240] 0 0
Ukraine
State/province [240] 0 0
Ivano-frankivsk
Country [241] 0 0
Ukraine
State/province [241] 0 0
Kherson
Country [242] 0 0
Ukraine
State/province [242] 0 0
Kyiv
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Cambridgeshire
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Devon
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Hampshire
Country [246] 0 0
United Kingdom
State/province [246] 0 0
London, City Of
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Barnsley
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Edinburgh
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Liverpool
Country [250] 0 0
United Kingdom
State/province [250] 0 0
London
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Newcastle upon Tyne
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Tooting

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03398135