A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
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ClinicalTrials.gov Identifier: NCT03398148 |
Recruitment Status :
Recruiting
First Posted : January 12, 2018
Last Update Posted : February 7, 2019
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The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.
The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis (UC) | Drug: risankizumab IV Drug: placebo for risankizumab Drug: risankizumab SC | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 720 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy |
Actual Study Start Date : | March 7, 2018 |
Estimated Primary Completion Date : | September 23, 2020 |
Estimated Study Completion Date : | August 29, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
|
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
|
Experimental: Substudy 2, Induction 1: Open-label Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
|
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
|
Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Placebo Comparator: Substudy 1, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Drug: placebo for risankizumab
placebo for risankizumab |
Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
|
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
|
Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
|
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
|
Placebo Comparator: Substudy 2, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
Drug: placebo for risankizumab placebo for risankizumab |
Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
Experimental: Substudy 1, Induction 1: Open-label Risankizumab Dose 3
Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.
|
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
|
- Percentage of participants with clinical remission per adapted Mayo Score at Week 12 [ Time Frame: Week 12 ]Clinical remission per adapted Mayo Score.
- Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline [ Time Frame: Week 12 ]Clinical remission per full Mayo Score.
- Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
- Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
- 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.
- Percentage of participants achieving clinical response per adapted Mayo Score at week 12 [ Time Frame: Week 12 ]Clinical response per adapted Mayo Score.
- Percentage of participants with endoscopic remission at Week 12 [ Time Frame: Week 12 ]Endoscopic remission per endoscopy subscore.
- Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4 [ Time Frame: Week 4 ]Clinical response per partial adapted Mayo Score (without endoscopy).
- Percentage of participants with mucosal healing at Week 12 [ Time Frame: Week 12 ]Mucosal healing defined as endoscopic and histologic remission.
- 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.
- Percentage of participants with hospitalization through Week 12 [ Time Frame: 12 weeks ]Participants with an event that results in admission to the hospital.
- Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12 [ Time Frame: 12 weeks ]Participants who underwent surgery related to UC.
- Percentage of participants with endoscopic improvement at Week 12 [ Time Frame: Week 12 ]Endoscopic improvement per endoscopy subscore.

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
- Active UC as assessed by adapted Mayo Score
- Demonstrated intolerance or inadequate response to one or more biologic therapies
- Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.
Exclusion Criteria:
- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
- Subject receiving prohibited medications and treatment.
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- Subject with currently known complications of UC (e.g., megacolon).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398148
Contact: ABBVIE CALL CENTER | 847.283.8955 | abbvieclinicaltrials@abbvie.com |

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03398148 History of Changes |
Other Study ID Numbers: |
M16-067 2016-004677-40 ( EudraCT Number ) |
First Posted: | January 12, 2018 Key Record Dates |
Last Update Posted: | February 7, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
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. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
ABBV-066 BI 655066 |
Additional relevant MeSH terms:
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |