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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02513459




Registration number
NCT02513459
Ethics application status
Date submitted
30/07/2015
Date registered
31/07/2015
Date last updated
24/04/2020

Titles & IDs
Public title
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Scientific title
An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2015-001834-15
Secondary ID [2] 0 0
M15-989
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn 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 - Risankizumab 600 mg IV
Treatment: Drugs - Risankizumab 180 mg SC

Experimental: Risankizumab - Maintenance treatment with risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.


Treatment: Drugs: Risankizumab 600 mg IV
Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

Treatment: Drugs: Risankizumab 180 mg SC
Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over
Secondary outcome [1] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit
Timepoint [1] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [2] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit
Timepoint [2] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [3] 0 0
Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit
Timepoint [3] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [4] 0 0
Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit
Timepoint [4] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [5] 0 0
Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit
Timepoint [5] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [6] 0 0
Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit
Timepoint [6] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [7] 0 0
Percentage of Participants With Mucosal Healing by Visit
Timepoint [7] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [8] 0 0
Percentage of Participants Achieving Deep Remission by Visit
Timepoint [8] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [9] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit
Timepoint [9] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [10] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit
Timepoint [10] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [11] 0 0
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit
Timepoint [11] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [12] 0 0
Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit
Timepoint [12] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [13] 0 0
Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit
Timepoint [13] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [14] 0 0
Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit
Timepoint [14] 0 0
Weeks 0, 48, 104, 152, and 200
Secondary outcome [15] 0 0
Mean Change From Baseline in Stool Frequency (SF) By Visit
Timepoint [15] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [16] 0 0
Mean Change From Baseline in Abdominal Pain (AP) Score By Visit
Timepoint [16] 0 0
Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184
Secondary outcome [17] 0 0
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit
Timepoint [17] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [18] 0 0
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit
Timepoint [18] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [19] 0 0
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit
Timepoint [19] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [20] 0 0
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit
Timepoint [20] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [21] 0 0
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit
Timepoint [21] 0 0
Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Secondary outcome [22] 0 0
Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit
Timepoint [22] 0 0
Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184
Secondary outcome [23] 0 0
Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit
Timepoint [23] 0 0
Weeks 0, 24, 56, 88, 120, 152, and 184

Eligibility
Key inclusion criteria
- Participants with Crohn's disease, who had successfully completed the preceding trial
NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Successful treatment
is defined as:

1. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's
Disease Activity Index (CDAI) from baseline by =100) but no remission (CDAI <
150) at Visit E1; or

2. Completion of period 3 in 1311.6 with a clinical response (drop in CDAI from
baseline by =100) and/or remission (CDAI < 150) at Visit E5; or

3. Completion of period 2 or 3 in 1311.6 per protocol with a clinical response or
remission before initiation of 1311.20 can roll-over either directly if that
response/remission is maintained or through an open-label i.v. re-induction phase
if they have lost their previous response/remission.

- Female participants:

1. Women of childbearing potential (not surgically sterilized and between menarche
and 1 year postmenopause), that, if sexually active agree to use one of the
appropriate medically accepted methods of birth control in addition to the
consistent and correct use of a condom from date of screening until 20 weeks
after last administration of study medication. Medically accepted methods of
contraception are: ethinyl estradiol containing contraceptives, diaphragm with
spermicide substance, and intrauterine device, or

2. Surgically sterilized female participants with documentation of prior
hysterectomy, tubal ligation or complete bilateral oophorectomy, or

3. Postmenopausal women with postmenopausal is defined as permanent cessation >/=1
year of previously occurring menses, and

4. Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine
pregnancy test prior to randomization.

- Male participants:

1. Who are documented to be sterile, or

2. Who consistently and correctly use effective method of contraception (i.e.
condoms) during the study and 20 weeks after last administration of study
medication.

- Be able to adhere to the study visit schedule and other protocol requirements.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who were not compliant with key study procedures (colonoscopy, treatment
compliance, endpoint assessment, contraception measures) in preceding trial 1311.6

- Participants who could not tolerate risankizumab (BI 655066/ ABBV-066) treatment for
tolerability or safety reasons in the preceding trial

- Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 20
weeks after receiving the last dose of study medication.

- Participants must agree not to receive a live virus or bacterial or Bacille
Calmette-Guérin vaccination during the study or up to 12 months after the last
administration of study drug.

- Participants who have developed malignancy, or suspicion of active malignant disease
during the preceding trial

- Are intending to participate in any other study using an investigational agent or
procedure during participation in this study.

- Cannot adhere to the concomitant medication requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
16/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2019
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles-Capitale
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Belgium
State/province [5] 0 0
Bonheiden
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Roeselare
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Germany
State/province [11] 0 0
Bayern
Country [12] 0 0
Germany
State/province [12] 0 0
Hannover
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Daegu Gwang Yeogsi
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul Teugbyeolsi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Netherlands
State/province [16] 0 0
Noord-Holland
Country [17] 0 0
Netherlands
State/province [17] 0 0
Maastricht
Country [18] 0 0
Poland
State/province [18] 0 0
Warsaw
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London, City Of
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridge
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Leeds
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Newcastle Upon Tyne
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study was to investigate long-term safety of risankizumab (BI
655066/ABBV-066) in participants with moderately to severely active Crohn's disease who
showed a clinical response or remission on previous treatment with risankizumab in Study
NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment.
Additional objectives of this study were to further investigate long-term efficacy,
tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02513459
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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