Crohn Disease
Conditions
Keywords
ABBV-066, BI 655066, Risankizumab
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.
Interventions
DRUGRisankizumab 600 mg IV
Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained
DRUGRisankizumab 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.
Sponsors
Boehringer Ingelheim
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | 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 | 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). |
| Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | 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 | 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. |
| Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | 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 | 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). |
| Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Weeks 0, 48, 104, 152, and 200 | 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). |
| Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Weeks 0, 48, 104, 152, and 200 | 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). |
| Percentage of Participants With Mucosal Healing by Visit | Weeks 0, 48, 104, 152, and 200 | 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. |
| Percentage of Participants Achieving Deep Remission by Visit | Weeks 0, 48, 104, 152, and 200 | 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). |
| Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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). |
| Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | 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 | 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. |
| Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | 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 | 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. |
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | 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 | 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. |
| Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Weeks 0, 48, 104, 152, and 200 | 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. |
| Mean Change From Baseline in Stool Frequency (SF) By Visit | 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 | 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. |
| Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | 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 | 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. |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192 | 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. |
| Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184 | 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. |
| Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Weeks 0, 24, 56, 88, 120, 152, and 184 | 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. |
| Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Weeks 0, 48, 104, 152, and 200 | 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. |
Countries
Belgium, Canada, Germany, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
All enrolled participants
Participants by arm
| Arm | Count |
|---|---|
| All Risankizumab Participants who received at least one dose of risankizumab in the current study | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lack of response | 1 |
| Overall Study | Loss of efficacy | 2 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Reproductive plans | 1 |
| Overall Study | Subject decision | 2 |
| Overall Study | Surgery planned-- not done | 1 |
| Overall Study | Withdrew consent | 5 |
Baseline characteristics
| Characteristic | All Risankizumab |
|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 12.97 |
| Baseline Corticosteroid Use Missing | 0 Participants |
| Baseline Corticosteroid Use No | 44 Participants |
| Baseline Corticosteroid Use Yes | 21 Participants |
| Crohn's Disease Activity Index (CDAI) | 304.771 units on a scale STANDARD_DEVIATION 77.9832 |
| High-sensitivity C-Reactive Protein (hs-CRP) | 20.315 mg/L STANDARD_DEVIATION 23.1676 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 29 Participants |
| Tumor Necrosis Factor (TNF) Antagonist Exposure Anti-TNF Experienced | 60 Participants |
| Tumor Necrosis Factor (TNF) Antagonist Exposure Anti-TNF Naive | 5 Participants |
| Tumor Necrosis Factor (TNF) Antagonist Exposure Missing | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 2 / 4 | 52 / 65 | 52 / 65 |
| serious Total, serious adverse events | 0 / 4 | 23 / 65 | 23 / 65 |
Outcome results
Primary
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.
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
Population: All participants who received at least one dose of risankizumab in the current study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab 600 mg IV | Number of Participants With Adverse Events | 2 Participants |
| Risankizumab 180 mg SC | Number of Participants With Adverse Events | 60 Participants |
| All Risankizumab | Number of Participants With Adverse Events | 60 Participants |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 8 | -1.11 units on a scale | Standard Deviation 0.357 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 0 | -0.61 units on a scale | Standard Deviation 1.006 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 4 | -0.82 units on a scale | Standard Deviation 0.768 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 8 | -1.44 units on a scale | Standard Deviation 0.746 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 16 | -1.45 units on a scale | Standard Deviation 0.773 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 24 | -1.33 units on a scale | Standard Deviation 0.804 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 40 | -1.49 units on a scale | Standard Deviation 0.766 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 48 | -1.46 units on a scale | Standard Deviation 0.72 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 56 | -1.51 units on a scale | Standard Deviation 0.815 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 64 | -1.47 units on a scale | Standard Deviation 0.825 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 72 | -1.50 units on a scale | Standard Deviation 0.839 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 80 | -1.44 units on a scale | Standard Deviation 0.816 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 88 | -1.49 units on a scale | Standard Deviation 0.787 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 96 | -1.43 units on a scale | Standard Deviation 0.881 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 104 | -1.52 units on a scale | Standard Deviation 0.861 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 112 | -1.57 units on a scale | Standard Deviation 0.89 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 120 | -1.58 units on a scale | Standard Deviation 0.735 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 128 | -1.61 units on a scale | Standard Deviation 0.776 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 136 | -1.65 units on a scale | Standard Deviation 0.792 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 144 | -1.64 units on a scale | Standard Deviation 0.836 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 152 | -1.52 units on a scale | Standard Deviation 0.833 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 160 | -1.28 units on a scale | Standard Deviation 0.788 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 168 | -1.54 units on a scale | Standard Deviation 0.657 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 176 | -1.50 units on a scale | Standard Deviation 0.67 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 184 | -1.89 units on a scale | Standard Deviation 0.921 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 32 | -1.49 units on a scale | Standard Deviation 0.76 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Abdominal Pain (AP) Score By Visit | Week 0 | -1.36 units on a scale | Standard Deviation 0.885 |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 8 | -119.40 units on a scale | Standard Deviation 32.967 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 4 | -92.68 units on a scale | Standard Deviation 40.688 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 0 | -50.70 units on a scale | Standard Deviation 84.565 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 24 | -194.34 units on a scale | Standard Deviation 82.84 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 8 | -206.75 units on a scale | Standard Deviation 83.58 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 0 | -198.47 units on a scale | Standard Deviation 101.762 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit | Week 16 | -205.93 units on a scale | Standard Deviation 92.837 |
Secondary
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.
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Week 104 | -9.24 units on a scale | Standard Deviation 6.035 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Week 0 | -8.08 units on a scale | Standard Deviation 5.973 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Week 48 | -9.32 units on a scale | Standard Deviation 6.014 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Week 152 | -9.75 units on a scale | Standard Deviation 7.254 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit | Week 200 | -10.76 units on a scale | Standard Deviation 5.209 |
Secondary
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.
Time frame: Weeks 0, 24, 56, 88, 120, 152, and 184
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 0 | -1983.9 μg/g | Standard Deviation 3402.12 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 24 | -2166.4 μg/g | Standard Deviation 4035.66 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 56 | -2277.8 μg/g | Standard Deviation 4104.19 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 88 | -2485.9 μg/g | Standard Deviation 4157.37 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 120 | -2031.9 μg/g | Standard Deviation 5187.92 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 152 | -2631.5 μg/g | Standard Deviation 4589.62 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit | Week 184 | -4436.1 μg/g | Standard Deviation 7455.55 |
Secondary
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.
Time frame: Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 0 | -14.64 mg/L | Standard Deviation 22.842 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 8 | -15.84 mg/L | Standard Deviation 22.548 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 24 | -12.76 mg/L | Standard Deviation 24.457 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 40 | -14.32 mg/L | Standard Deviation 24.08 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 56 | -16.11 mg/L | Standard Deviation 24.194 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 72 | -14.40 mg/L | Standard Deviation 21.878 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 120 | -13.81 mg/L | Standard Deviation 22.667 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 128 | -14.87 mg/L | Standard Deviation 20.133 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 136 | -15.78 mg/L | Standard Deviation 20.864 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 152 | -17.03 mg/L | Standard Deviation 20.998 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 160 | -18.43 mg/L | Standard Deviation 22.147 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 176 | -20.49 mg/L | Standard Deviation 25.062 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 184 | -25.01 mg/L | Standard Deviation 32.459 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 88 | -17.07 mg/L | Standard Deviation 23.312 |
| Risankizumab 600 mg IV | Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit | Week 104 | -14.44 mg/L | Standard Deviation 20.057 |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 120 | 22.25 units on a scale | Standard Deviation 10.473 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 0 | 20.44 units on a scale | Standard Deviation 11.68 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 24 | 18.26 units on a scale | Standard Deviation 11.587 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 48 | 20.29 units on a scale | Standard Deviation 10.861 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 72 | 20.64 units on a scale | Standard Deviation 12.547 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 96 | 19.12 units on a scale | Standard Deviation 13.064 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 144 | 20.46 units on a scale | Standard Deviation 10.639 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 168 | 18.44 units on a scale | Standard Deviation 10.658 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit | Week 192 | 22.67 units on a scale | Standard Deviation 14.962 |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 48 | 22.55 units on a scale | Standard Deviation 14.965 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 72 | 22.23 units on a scale | Standard Deviation 17.912 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 120 | 23.35 units on a scale | Standard Deviation 15.391 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 168 | 18.87 units on a scale | Standard Deviation 14.552 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 0 | 21.09 units on a scale | Standard Deviation 16.82 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 24 | 20.79 units on a scale | Standard Deviation 15.632 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 96 | 22.41 units on a scale | Standard Deviation 17.075 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 144 | 21.03 units on a scale | Standard Deviation 15.044 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit | Week 192 | 25.00 units on a scale | Standard Deviation 21.373 |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 192 | 11.67 units on a scale | Standard Deviation 9.266 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 0 | 11.04 units on a scale | Standard Deviation 8.23 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 24 | 10.57 units on a scale | Standard Deviation 7.652 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 48 | 11.64 units on a scale | Standard Deviation 7.487 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 72 | 11.20 units on a scale | Standard Deviation 8.731 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 96 | 10.59 units on a scale | Standard Deviation 8.556 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 120 | 11.92 units on a scale | Standard Deviation 7.347 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 144 | 10.93 units on a scale | Standard Deviation 8.309 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit | Week 168 | 10.87 units on a scale | Standard Deviation 9.503 |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 168 | 8.2 units on a scale | Standard Deviation 5.1 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 0 | 9.9 units on a scale | Standard Deviation 6.66 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 24 | 9.1 units on a scale | Standard Deviation 6.44 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 48 | 9.6 units on a scale | Standard Deviation 6.08 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 72 | 10.1 units on a scale | Standard Deviation 7.36 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 96 | 10.3 units on a scale | Standard Deviation 5.8 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 120 | 9.8 units on a scale | Standard Deviation 6.16 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 144 | 8.9 units on a scale | Standard Deviation 6.02 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit | Week 192 | 11.8 units on a scale | Standard Deviation 4.62 |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 72 | 64.14 units on a scale | Standard Deviation 42.229 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 144 | 61.34 units on a scale | Standard Deviation 34.894 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 192 | 71.17 units on a scale | Standard Deviation 41.911 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 0 | 62.48 units on a scale | Standard Deviation 38.791 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 24 | 58.72 units on a scale | Standard Deviation 35.626 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 48 | 64.03 units on a scale | Standard Deviation 33.039 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 96 | 62.38 units on a scale | Standard Deviation 39.22 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 120 | 67.28 units on a scale | Standard Deviation 34.39 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit | Week 168 | 56.36 units on a scale | Standard Deviation 33.035 |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 4 | -35.25 units on a scale | Standard Deviation 27.011 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 8 | -53.75 units on a scale | Standard Deviation 24.405 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 0 | -27.75 units on a scale | Standard Deviation 48.979 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 144 | -115.35 units on a scale | Standard Deviation 53.46 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 0 | -105.46 units on a scale | Standard Deviation 58.807 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 8 | -109.53 units on a scale | Standard Deviation 49.419 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 16 | -108.32 units on a scale | Standard Deviation 52.848 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 24 | -105.40 units on a scale | Standard Deviation 50.167 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 32 | -109.41 units on a scale | Standard Deviation 56.459 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 40 | -116.33 units on a scale | Standard Deviation 43.511 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 48 | -111.29 units on a scale | Standard Deviation 48.048 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 56 | -115.54 units on a scale | Standard Deviation 51.279 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 80 | -106.42 units on a scale | Standard Deviation 58.71 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 88 | -108.67 units on a scale | Standard Deviation 51.214 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 96 | -109.81 units on a scale | Standard Deviation 50.927 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 104 | -109.10 units on a scale | Standard Deviation 49.562 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 112 | -109.75 units on a scale | Standard Deviation 52.951 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 120 | -111.10 units on a scale | Standard Deviation 47.36 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 128 | -113.02 units on a scale | Standard Deviation 50.738 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 152 | -109.17 units on a scale | Standard Deviation 56.659 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 160 | -96.70 units on a scale | Standard Deviation 54.018 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 168 | -111.09 units on a scale | Standard Deviation 55.287 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 176 | -103.06 units on a scale | Standard Deviation 42.717 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 64 | -113.02 units on a scale | Standard Deviation 57.338 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 184 | -129.13 units on a scale | Standard Deviation 70.484 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 72 | -112.11 units on a scale | Standard Deviation 56.819 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit | Week 136 | -113.00 units on a scale | Standard Deviation 51.575 |
Secondary
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.
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Week 0 | -9.63 units on a scale | Standard Deviation 8.001 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Week 48 | -12.35 units on a scale | Standard Deviation 7.753 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Week 104 | -11.56 units on a scale | Standard Deviation 8.06 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Week 152 | -12.63 units on a scale | Standard Deviation 9.139 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit | Week 200 | -13.36 units on a scale | Standard Deviation 7.521 |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab 600 mg IV | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 0 | -0.46 number of liquid stools in prior 7 days | Standard Deviation 2.319 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 4 | -0.46 number of liquid stools in prior 7 days | Standard Deviation 1.584 |
| Risankizumab 600 mg IV | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 8 | -1.07 number of liquid stools in prior 7 days | Standard Deviation 1.421 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 8 | -4.22 number of liquid stools in prior 7 days | Standard Deviation 3.16 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 16 | -4.10 number of liquid stools in prior 7 days | Standard Deviation 3.223 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 24 | -4.19 number of liquid stools in prior 7 days | Standard Deviation 3.209 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 32 | -4.08 number of liquid stools in prior 7 days | Standard Deviation 3.536 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 40 | -4.58 number of liquid stools in prior 7 days | Standard Deviation 3.037 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 48 | -4.31 number of liquid stools in prior 7 days | Standard Deviation 3.278 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 56 | -4.48 number of liquid stools in prior 7 days | Standard Deviation 3.282 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 80 | -4.00 number of liquid stools in prior 7 days | Standard Deviation 3.469 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 88 | -4.04 number of liquid stools in prior 7 days | Standard Deviation 3.331 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 96 | -4.27 number of liquid stools in prior 7 days | Standard Deviation 3.037 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 104 | -4.00 number of liquid stools in prior 7 days | Standard Deviation 2.943 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 112 | -3.91 number of liquid stools in prior 7 days | Standard Deviation 2.951 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 120 | -3.99 number of liquid stools in prior 7 days | Standard Deviation 2.84 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 128 | -4.05 number of liquid stools in prior 7 days | Standard Deviation 3.06 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 136 | -3.95 number of liquid stools in prior 7 days | Standard Deviation 3.137 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 144 | -4.13 number of liquid stools in prior 7 days | Standard Deviation 3.308 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 152 | -4.00 number of liquid stools in prior 7 days | Standard Deviation 3.15 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 160 | -3.71 number of liquid stools in prior 7 days | Standard Deviation 3.044 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 168 | -4.08 number of liquid stools in prior 7 days | Standard Deviation 3.353 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 176 | -3.61 number of liquid stools in prior 7 days | Standard Deviation 2.583 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 64 | -4.41 number of liquid stools in prior 7 days | Standard Deviation 3.514 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 184 | -4.50 number of liquid stools in prior 7 days | Standard Deviation 3.881 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 72 | -4.25 number of liquid stools in prior 7 days | Standard Deviation 3.513 |
| Risankizumab 180 mg SC | Mean Change From Baseline in Stool Frequency (SF) By Visit | Week 0 | -4.13 number of liquid stools in prior 7 days | Standard Deviation 3.273 |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 4 | 25.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 8 | 25.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 0 | 25.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 96 | 84.62 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 104 | 85.71 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 128 | 86.96 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 136 | 76.92 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 144 | 78.38 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 16 | 71.88 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 24 | 74.60 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 32 | 78.69 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 40 | 81.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 48 | 79.31 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 56 | 80.70 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 64 | 87.27 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 72 | 83.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 80 | 79.25 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 88 | 78.43 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 112 | 87.50 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 120 | 83.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 152 | 76.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 160 | 78.26 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 168 | 70.59 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 176 | 60.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 184 | 40.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 0 | 72.31 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit | Week 8 | 73.85 percentage of participants |
Secondary
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).
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 4 | 75.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 0 | 50.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 8 | 100.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 24 | 95.24 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 72 | 94.44 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 80 | 92.45 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 88 | 92.16 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 96 | 92.31 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 120 | 93.75 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 128 | 93.48 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 136 | 92.31 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 144 | 91.89 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 160 | 91.30 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 168 | 82.35 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 0 | 90.77 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 32 | 95.08 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 40 | 96.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 48 | 94.83 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 56 | 92.98 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 64 | 96.36 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 104 | 93.88 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 112 | 93.75 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 152 | 93.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 176 | 80.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 184 | 80.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 8 | 98.46 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit | Week 16 | 92.19 percentage of participants |
Secondary
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).
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Week 0 | 42.86 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Week 48 | 56.45 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Week 104 | 62.79 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Week 152 | 58.97 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit | Week 200 | 85.71 percentage of participants |
Secondary
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).
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Week 0 | 58.73 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Week 48 | 72.58 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Week 104 | 81.40 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Week 152 | 82.05 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit | Week 200 | 100.00 percentage of participants |
Secondary
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).
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Deep Remission by Visit | Week 0 | 34.92 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Deep Remission by Visit | Week 48 | 47.54 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Deep Remission by Visit | Week 104 | 53.49 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Deep Remission by Visit | Week 152 | 42.86 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Deep Remission by Visit | Week 200 | 0.00 percentage of participants |
Secondary
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.
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 0 | 62.50 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 24 | 58.46 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 168 | 69.57 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 192 | 66.67 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 48 | 70.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 72 | 69.23 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 96 | 72.55 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 120 | 70.83 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit | Week 144 | 65.00 percentage of participants |
Secondary
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).
Time frame: Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 0 | 92.19 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 24 | 89.23 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 48 | 95.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 72 | 88.46 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 96 | 90.20 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 120 | 95.83 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 144 | 92.50 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 168 | 86.96 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit | Week 192 | 100.00 percentage of participants |
Secondary
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.
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 0 | 25.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 4 | 25.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 8 | 50.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 0 | 73.85 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 8 | 80.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 16 | 78.13 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 24 | 77.78 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 32 | 85.25 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 48 | 82.76 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 56 | 87.72 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 64 | 81.82 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 72 | 81.48 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 80 | 81.13 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 88 | 82.35 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 96 | 84.62 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 112 | 91.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 120 | 85.42 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 128 | 89.13 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 136 | 87.50 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 144 | 86.49 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 152 | 86.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 160 | 73.91 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 168 | 77.78 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 176 | 60.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 184 | 40.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 40 | 83.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit | Week 104 | 85.71 percentage of participants |
Secondary
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).
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
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 8 | 50.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 0 | 50.00 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 4 | 50.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 80 | 88.68 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 104 | 87.76 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 128 | 91.30 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 184 | 100.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 16 | 90.63 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 24 | 92.06 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 32 | 86.89 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 40 | 98.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 48 | 93.10 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 64 | 90.91 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 72 | 88.89 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 88 | 86.27 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 96 | 88.46 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 112 | 87.50 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 120 | 91.67 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 136 | 92.50 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 144 | 89.19 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 152 | 93.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 160 | 86.96 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 168 | 83.33 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 0 | 83.08 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 176 | 100.00 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 8 | 86.15 percentage of participants |
| Risankizumab 180 mg SC | Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit | Week 56 | 91.23 percentage of participants |
Secondary
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.
Time frame: Weeks 0, 48, 104, 152, and 200
Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab 600 mg IV | Percentage of Participants With Mucosal Healing by Visit | Week 200 | 42.86 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants With Mucosal Healing by Visit | Week 0 | 29.69 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants With Mucosal Healing by Visit | Week 48 | 35.48 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants With Mucosal Healing by Visit | Week 104 | 39.53 percentage of participants |
| Risankizumab 600 mg IV | Percentage of Participants With Mucosal Healing by Visit | Week 152 | 43.59 percentage of participants |