Clinical trial NCT02513459: A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: ABBV-066
BI 655066
Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2015-07-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with clinical response or remission at the end of Study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993) or at screening for this study were rolled over directly into this study and received maintenance therapy of risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who lost response or remission between the completion of Study NCT02031276 and enrollment in this study received open-label intravenous (IV) re-induction treatment with risankizumab consisting of 3 infusions of 600 mg IV every 4 weeks (q4w), after which eligibility was assessed if clinical response was re-gained. If clinical response or remission was achieved, participants continued with maintenance treatment of risankizumab 180 mg SC q8w beginning at Visit 5.
Primary purpose: TREATMENT

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.

Detailed description: This was a single group, open-label long-term extension study that assessed the long-term safety, efficacy, and pharmacokinetics of risankizumab in participants with moderately to severely active Crohn's disease. This study was terminated early by AbbVie to enable participants who completed the study to rollover into Study NCT03105102 (AbbVie M16-000 Sub-Study 3 \[Phase 3 OLE study\]) for further OLE treatment within the Phase 3 program, which allows for risankizumab dose escalation if needed.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 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 outcomes:
measure: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit
timeFrame: 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
measure: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit
timeFrame: 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
measure: Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit
timeFrame: 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
measure: Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit
timeFrame: 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
measure: Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Percentage of Participants With Mucosal Healing by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Percentage of Participants Achieving Deep Remission by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit
timeFrame: 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
measure: Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit
timeFrame: 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
measure: Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit
timeFrame: Weeks 0, 48, 104, 152, and 200
measure: Mean Change From Baseline in Stool Frequency (SF) By Visit
timeFrame: 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
measure: Mean Change From Baseline in Abdominal Pain (AP) Score By Visit
timeFrame: 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
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit
timeFrame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
measure: Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit
timeFrame: Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184
measure: Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit
timeFrame: Weeks 0, 24, 56, 88, 120, 152, and 184
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068
state: Maryland
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 155066
state: Michigan
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 154985
state: Bruxelles-Capitale
city: Liège
country: Belgium
facility: CHU de Liege /ID# 154988
state: Liege
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis /ID# 154984
city: Brussels
country: Belgium
facility: ULB Erasme /ID# 154987
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 154989
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 154986
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 154983
city: Hamilton
country: Canada
facility: McMaster University Med Cent /ID# 155019
state: Ontario
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 155039
state: Bayern
city: Hannover
country: Germany
facility: Med Hochschule Hanover /ID# 155041
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Med Ctr /ID# 155056
state: Daegu Gwang Yeogsi
city: Jongno-Gu
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 155054
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital /ID# 155055
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 155053
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum /ID# 155058
state: Noord-Holland
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 155059
city: Warsaw
country: Poland
facility: NZOZ Vivamed /ID# 155061
city: Wroclaw
country: Poland
facility: Lexmedica /Id# 155062
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals /ID# 155063
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 155064
city: Madrid
country: Spain
facility: Hospital Univ de la Princesa /ID# 155065
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Found /ID# 155046
state: London, City Of
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital /ID# 155047
city: Leeds
country: United Kingdom
facility: St. James University Hospital /ID# 155050
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital /ID# 155048
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Ferrante M, Feagan BG, Panes J, Baert F, Louis E, Dewit O, Kaser A, Duan WR, Pang Y, Lee WJ, Gustafson D, Liao X, Wallace K, Kalabic J, D'Haens GR. Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. J Crohns Colitis. 2021 Dec 18;15(12):2001-2010. doi: 10.1093/ecco-jcc/jjab093.