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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Risankizumab 600 mg IV; Drug: Risankizumab 180 mg SC

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Ziekenhuis /ID# 154984
  • Brussels, Belgium, 1070
    • ULB Erasme /ID# 154987
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 154989
  • Leuven, Belgium, 3000
    • UZ Leuven /ID# 154986
  • Roeselare, Belgium, 8800
    • AZ-Delta /ID# 154983
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Cliniques Universitaires Saint Luc /ID# 154985
  • Liege
    • Liège, Liege, Belgium, 4000
      • CHU de Liege /ID# 154988
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University Med Cent /ID# 155019
• Germany
  • Hannover, Germany, 30625
    • Med Hochschule Hanover /ID# 155041
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 155039
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 155053
  • Daegu Gwang Yeogsi
    • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
      • Yeungnam University Med Ctr /ID# 155056
  • Seoul Teugbyeolsi
    • Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
      • Kangbuk Samsung Hospital /ID# 155054
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Severance Hospital /ID# 155055
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum /ID# 155059
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Academisch Medisch Centrum /ID# 155058
• Poland
  • Warsaw, Poland, 03-580
    • NZOZ Vivamed /ID# 155061
  • Wroclaw, Poland, 53-114
    • Lexmedica /Id# 155062
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 155064
  • Madrid, Spain, 28006
    • Hospital Univ de la Princesa /ID# 155065
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Duran i Reynals /ID# 155063
• United Kingdom
  • Cambridge, United Kingdom, CB2 0SP
    • Addenbrookes Hospital /ID# 155047
  • Leeds, United Kingdom, LS9 7TF
    • St. James University Hospital /ID# 155050
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital /ID# 155048
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Found /ID# 155046
• United States
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clin Res Inst of Michigan, LLC /ID# 155066

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Risankizumab 600 mg IV; Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained; Other Names: BI 655066; ABBV-066; Drug: 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.; Other Names: BI 655066; ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	A treatment emergent adverse event was defined as an event that occurred or worsened on or after the first dose of study drug through 140 days after the last dose in the current study for participants not rolling over into M16-000 Sub-study 3 or until the first dose of study drug in NCT03105102. All treatment-emergent serious and nonserious adverse events were collected, whether elicited or spontaneously reported by the participant.	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 Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit	The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score < 150.	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	The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical response is defined as CDAI score < 150 or a reduction from baseline of at least 100 points. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).	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 Patient Reported Outcome 2 (PRO-2) Remission by Visit	The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Remission is defined as PRO-2 score < 75.	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 Patient Reported Outcome 2 (PRO-2) Response by Visit	The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. PRO-2 response is defined as a decrease from baseline of 50 points or more. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).	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	CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Remission is defined as a score of 4 or less, by visit (or for participants with initial isolated ileitis a score of 2 or less).	Weeks 0, 48, 104, 152, and 200
Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit	CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Response is defined as a score of 7 or less (or for participants with initial isolated ileitis > 50% reduction from baseline). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).	Weeks 0, 48, 104, 152, and 200
Percentage of Participants With Mucosal Healing by Visit	Mucosal healing is defined as Crohn's Disease Endoscopy Index of Severity (CDEIS) ulcerations sub-score (deep ulceration, superficial ulceration, ulcerated stenosis) of 0 as evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The overall CDEIS score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.	Weeks 0, 48, 104, 152, and 200
Percentage of Participants Achieving Deep Remission by Visit	Deep remission is defined as clinical remission (CDAI < 150) and CDEIS remission (CDEIS score of 4 or less, by visit or for participants with initial isolated ileitis a score of 2 or less).	Weeks 0, 48, 104, 152, and 200
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ remission is defined as IBDQ total score > 170 points.	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ response is defined as increase in IBDQ total score >16 points from baseline. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit	The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.	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 Patient Reported Outcome 2 (PRO-2) Scores by Visit	The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.	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	CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.	Weeks 0, 48, 104, 152, and 200
Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit	SES-CD is calculated based the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.	Weeks 0, 48, 104, 152, and 200
Mean Change From Baseline in Stool Frequency (SF) By Visit	Participants were asked to record the frequency of liquid stools on a daily basis. The number of liquid stools in the prior 7 days was summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.	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 Abdominal Pain (AP) Score By Visit	Participants were asked to rate and record daily abdominal pain on a scale of 0 to 3 [none (0), mild (1), moderate (2) and severe (3)]. The ratings in the prior 7 days were summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.	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) Total Score by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.	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	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit	The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.	Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit	Concentration of serum high-sensitivity C-reactive Protein (hs-CRP) was analyzed by a central laboratory. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response, and higher levels indicate more inflammation. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.	Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184
Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit	Fecal calprotectin (FCP) is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Stool samples were analyzed by a central laboratory for fecal calprotectin levels. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.	Weeks 0, 24, 56, 88, 120, 152, and 184

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2015
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Risankizumab; ABBV-066; BI 655066
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M15-989; 1311.2 (Other Grant/Funding Number: Boehringer Ingelhem); 2015-001834-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No