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History of Changes for Study: NCT03105128
A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 4, 2017 None (earliest Version on record)
2 September 22, 2017 Study Status
3 November 14, 2017 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Oversight
4 December 19, 2017 Contacts/Locations, Study Status, IPDSharing, Arms and Interventions and Oversight
5 January 22, 2018 Study Status and Contacts/Locations
6 January 31, 2018 Contacts/Locations, Study Status and IPDSharing
7 February 28, 2018 Contacts/Locations and Study Status
8 March 30, 2018 Contacts/Locations and Study Status
9 April 24, 2018 Contacts/Locations and Study Status
10 May 29, 2018 Contacts/Locations and Study Status
11 June 13, 2018 Study Status
12 July 31, 2018 Contacts/Locations, IPDSharing and Study Status
13 August 29, 2018 Contacts/Locations and Study Status
14 September 21, 2018 Contacts/Locations and Study Status
15 September 25, 2018 Contacts/Locations and Study Status
16 October 15, 2018 Contacts/Locations and Study Status
17 November 2, 2018 Contacts/Locations and Study Status
18 November 26, 2018 Contacts/Locations and Study Status
19 November 28, 2018 Contacts/Locations and Study Status
20 December 26, 2018 Contacts/Locations and Study Status
21 January 9, 2019 Contacts/Locations and Study Status
22 January 11, 2019 Contacts/Locations and Study Status
23 January 23, 2019 Contacts/Locations and Study Status
24 February 21, 2019 Contacts/Locations and Study Status
25 February 27, 2019 Contacts/Locations and Study Status
26 March 19, 2019 Contacts/Locations, Outcome Measures, Study Status, Eligibility and Study Design
27 April 4, 2019 Contacts/Locations, Study Status and Study Design
28 May 3, 2019 Contacts/Locations and Study Status
29 May 24, 2019 Contacts/Locations and Study Status
30 June 14, 2019 Contacts/Locations and Study Status
31 July 12, 2019 Contacts/Locations and Study Status
32 July 31, 2019 Contacts/Locations and Study Status
33 August 29, 2019 Contacts/Locations and Study Status
34 September 27, 2019 Contacts/Locations and Study Status
35 October 25, 2019 Contacts/Locations and Study Status
36 November 8, 2019 Contacts/Locations and Study Status
37 December 5, 2019 Contacts/Locations and Study Status
38 December 27, 2019 Contacts/Locations and Study Status
39 January 16, 2020 Outcome Measures, Study Status, Contacts/Locations, Arms and Interventions, Conditions, Study Description and Study Identification
40 February 7, 2020 Contacts/Locations and Study Status
41 February 28, 2020 Contacts/Locations and Study Status
42 March 23, 2020 Contacts/Locations and Study Status
43 May 5, 2020 Contacts/Locations and Study Status
44 June 9, 2020 Contacts/Locations, Study Status and Eligibility
45 June 17, 2020 IPDSharing, Contacts/Locations, Eligibility and Study Status
46 June 30, 2020 Contacts/Locations and Study Status
47 July 29, 2020 Contacts/Locations and Study Status
48 August 17, 2020 Contacts/Locations, Study Status, References, Eligibility and Arms and Interventions
49 September 1, 2020 Recruitment Status, Contacts/Locations, Study Status and Study Design
50 October 6, 2020 Outcome Measures, Contacts/Locations, Study Status and Eligibility
51 January 6, 2021 Contacts/Locations, Study Status and Study Design
52 March 3, 2021 Contacts/Locations, Study Status and Study Design
53 April 29, 2021 Recruitment Status, Contacts/Locations and Study Status
54 July 16, 2021 Study Status
55 March 31, 2022
Quality Control Review has not concluded Returned: April 27, 2022
Outcome Measures, Contacts/Locations, Study Status, IPDSharing, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
56 May 13, 2022
Quality Control Review has not concluded Returned: June 7, 2022
Outcome Measures and Study Status
57 June 9, 2022 Study Status, Outcome Measures
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Study NCT03105128
Submitted Date:  April 4, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: M16-006
Brief Title: A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Secondary IDs: 2016-003123-32 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Not yet recruiting
Study Start: May 12, 2017
Primary Completion: October 22, 2019 [Anticipated]
Study Completion: February 14, 2020 [Anticipated]
First Submitted: April 4, 2017
First Submitted that
Met QC Criteria:
April 4, 2017
First Posted: April 7, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 4, 2017
Last Update Posted: April 7, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AbbVie
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).
Detailed Description:
Open or close this module Conditions
Conditions: Crohn's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 6
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 940 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo (Period 1)
Subjects randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: placebo for risankizumab
Placebo for risankizumab administered by intravenous infusion
Experimental: Risankizumab Dose 1 (Period 1)
Subjects randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Names:
  • ABBV-066
  • BI 655066
Experimental: Risankizumab Dose 2 (Period 1)
Subjects randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Names:
  • ABBV-066
  • BI 655066
Experimental: Risankizumab Dose 1 (Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Names:
  • ABBV-066
  • BI 655066
Experimental: Risankizumab Dose 2 (Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
Experimental: Risankizumab Dose 3 (Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 12
[ Time Frame: Week 12 ]

Clinical remission per average daily SF and average daily AP score.
2. Percentage of participants with endoscopic response at Week 12
[ Time Frame: Week 12 ]

Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Secondary Outcome Measures:
1. Percentage of participants with enhanced clinical response at Week 4
[ Time Frame: Week 4 ]

Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
2. Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
[ Time Frame: Week 12 ]

The CDAI is used to evaluate disease activity in patients with Crohn's disease.
3. Percentage of participants with enhanced clinical response at Week 12
[ Time Frame: Week 12 ]

Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
4. Percentage of participants with clinical remission per average daily SF and average daily AP score at Week 4
[ Time Frame: Week 4 ]

Clinical remission per average daily SF and average daily AP score.
5. Percentage of participants with enhanced clinical response and endoscopic response at Week 12
[ Time Frame: Week 12 ]

Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline in SES-CD.
6. Percentage of participants with endoscopic healing at Week 12
[ Time Frame: Week 12 ]

Endoscopic healing was assessed using SES-CD.
7. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12
[ Time Frame: Baseline, Week 12 ]

The CSS is a patient questionnaire to assess severity of Crohn's symptoms.
8. Percentage of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline
[ Time Frame: Week 12 ]

Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
9. Percentage of participants with hospitalization through Week 12
[ Time Frame: 12 weeks ]

Participants with an event that results in admission to the hospital.
10. Percentage of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline
[ Time Frame: Baseline, Week 12 ]

Participants with draining fistulas at Week 12 in participants who had draining fistulas at baseline.
11. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12
[ Time Frame: Baseline, Week 12 ]

The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
12. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12
[ Time Frame: Baseline, Week 12 ]

The SF-36 is an indicator of overall health status.
13. Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12
[ Time Frame: 12 weeks ]

Participants who underwent surgery related to CD.
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
  • Diagnosis of CD for at least 3 months prior to Baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
  • Subjects with unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
  • Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab)
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch
Open or close this module Contacts/Locations
Central Contact Person: AbbVie_Call Center
Telephone: 847.283.8955
Email: abbvieclinicaltrials@abbvie.com
Study Officials: AbbVie Inc
Study Director
AbbVie
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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