A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02513459
• Date of registration: 30/07/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• 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
• Date of first enrolment: September 16, 2015
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02513459
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Germany, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Risankizumab 180 mg SC

Drug: Risankizumab 600 mg IV

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: 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(s)

Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit [Time Frame: 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]

Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit [Time Frame: 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]

Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit [Time Frame: Weeks 0, 24, 56, 88, 120, 152, and 184]

Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Abdominal Pain (AP) Score By Visit [Time Frame: 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]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit [Time Frame: 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]

Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit [Time Frame: Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184]

Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit [Time Frame: 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]

Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit [Time Frame: 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]

Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit [Time Frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192]

Mean Change From Baseline in Stool Frequency (SF) By Visit [Time Frame: 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]

Percentage of Participants Achieving Deep Remission by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit [Time Frame: 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]

Percentage of Participants With Mucosal Healing by Visit [Time Frame: Weeks 0, 48, 104, 152, and 200]

Secondary ID(s)

1311.2

2015-001834-15

M15-989

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim

Results

• Results available: Yes
• Date Posted: 24/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02513459