Back to results

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

Primary Purpose

Crohn Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Risankizumab 600 mg IV

Risankizumab 180 mg SC

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring ABBV-066, BI 655066, Risankizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068
Clin Res Inst of Michigan, LLC /ID# 155066
Cliniques Universitaires Saint Luc /ID# 154985
CHU de Liege /ID# 154988
Imelda Ziekenhuis /ID# 154984
ULB Erasme /ID# 154987
AZ Groeninge /ID# 154989
UZ Leuven /ID# 154986
AZ-Delta /ID# 154983
McMaster University Med Cent /ID# 155019
Universitaetsklinikum Erlangen /ID# 155039
Med Hochschule Hanover /ID# 155041
Yeungnam University Med Ctr /ID# 155056
Kangbuk Samsung Hospital /ID# 155054
Severance Hospital /ID# 155055
Asan Medical Center /ID# 155053
Academisch Medisch Centrum /ID# 155058
Maastricht Universitair Medisch Centrum /ID# 155059
NZOZ Vivamed /ID# 155061
Lexmedica /Id# 155062
Hospital Duran i Reynals /ID# 155063
Hospital Clinic de Barcelona /ID# 155064
Hospital Univ de la Princesa /ID# 155065
Guy's and St Thomas' NHS Found /ID# 155046
Addenbrookes Hospital /ID# 155047
St. James University Hospital /ID# 155050
The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049
John Radcliffe Hospital /ID# 155048

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risankizumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit

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.

Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit

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).

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).

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.

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).

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.

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).

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit

Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02513459

First Posted

July 30, 2015

Last Updated

April 9, 2020

Sponsor

AbbVie

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02513459

Brief Title

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

Official Title

An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 16, 2015 (Actual)

Primary Completion Date

June 19, 2019 (Actual)

Study Completion Date

June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

ABBV-066, BI 655066, Risankizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risankizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Risankizumab 600 mg IV

Other Intervention Name(s)

BI 655066, ABBV-066

Intervention Description

Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

Intervention Type

Drug

Intervention Name(s)

Risankizumab 180 mg SC

Other Intervention Name(s)

BI 655066, ABBV-066

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit

Description

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

Title

Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit

Description

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

Title

Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit

Description

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

Title

Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit

Description

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

Title

Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit

Description

Time Frame

Weeks 0, 48, 104, 152, and 200

Title

Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit

Description

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

Title

Percentage of Participants With Mucosal Healing by Visit

Description

Time Frame

Weeks 0, 48, 104, 152, and 200

Title

Percentage of Participants Achieving Deep Remission by Visit

Description

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

Title

Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit

Description

Time Frame

Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192

Title

Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit

Description

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

Title

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit

Description

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

Title

Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit

Description

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

Title

Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit

Description

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

Title

Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit

Description

Time Frame

Weeks 0, 48, 104, 152, and 200

Title

Mean Change From Baseline in Stool Frequency (SF) By Visit

Description

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

Title

Mean Change From Baseline in Abdominal Pain (AP) Score By Visit

Description

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

Title

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit

Description

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

Title

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit

Description

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

Title

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit

Description

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

Title

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit

Description

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

Title

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit

Description

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

Title

Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit

Description

Time Frame

Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184

Title

Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit

Description

Time Frame

Weeks 0, 24, 56, 88, 120, 152, and 184

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants with Crohn's disease, who had successfully completed the preceding trial NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Successful treatment is defined as: 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 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 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: 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 Surgically sterilized female participants with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or Postmenopausal women with postmenopausal is defined as permanent cessation >/=1 year of previously occurring menses, and Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine pregnancy test prior to randomization. Male participants: Who are documented to be sterile, or 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Clin Res Inst of Michigan, LLC /ID# 155066

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Cliniques Universitaires Saint Luc /ID# 154985

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

CHU de Liege /ID# 154988

City

Liège

State/Province

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Imelda Ziekenhuis /ID# 154984

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

ULB Erasme /ID# 154987

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

AZ Groeninge /ID# 154989

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

UZ Leuven /ID# 154986

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

AZ-Delta /ID# 154983

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

McMaster University Med Cent /ID# 155019

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Universitaetsklinikum Erlangen /ID# 155039

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

Med Hochschule Hanover /ID# 155041

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Yeungnam University Med Ctr /ID# 155056

City

Daegu

State/Province

Daegu Gwang Yeogsi

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Kangbuk Samsung Hospital /ID# 155054

City

Jongno-Gu

State/Province

Seoul Teugbyeolsi

ZIP/Postal Code

03181

Country

Korea, Republic of

Facility Name

Severance Hospital /ID# 155055

City

Seoul

State/Province

Seoul Teugbyeolsi

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Asan Medical Center /ID# 155053

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Academisch Medisch Centrum /ID# 155058

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Maastricht Universitair Medisch Centrum /ID# 155059

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

NZOZ Vivamed /ID# 155061

City

Warsaw

ZIP/Postal Code

03-580

Country

Poland

Facility Name

Lexmedica /Id# 155062

City

Wroclaw

ZIP/Postal Code

53-114

Country

Poland

Facility Name

Hospital Duran i Reynals /ID# 155063

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Clinic de Barcelona /ID# 155064

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Univ de la Princesa /ID# 155065

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Guy's and St Thomas' NHS Found /ID# 155046

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Addenbrookes Hospital /ID# 155047

City

Cambridge

ZIP/Postal Code

CB2 0SP

Country

United Kingdom

Facility Name

St. James University Hospital /ID# 155050

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

John Radcliffe Hospital /ID# 155048

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

34077509

Citation

Ferrante M, Feagan BG, Panes J, Baert F, Louis E, Dewit O, Kaser A, Duan WR, Pang Y, Lee WJ, Gustafson D, Liao X, Wallace K, Kalabic J, D'Haens GR. Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. J Crohns Colitis. 2021 Dec 18;15(12):2001-2010. doi: 10.1093/ecco-jcc/jjab093.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs