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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03398148
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1547 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
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : September 23, 2022
Estimated Study Completion Date : June 5, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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 1, Induction 1: Open-label Risankizumab Dose 1
Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.
 Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066

Drug: placebo for risankizumab
placebo for risankizumab
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066
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:
  • ABBV-066
  • BI 655066


Outcome Measures
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Primary Outcome Measures :
  1. Sub-Study 1 and Sub-Study 2: Percentage of Participants with Clinical Remission per Adapted Mayo Score [ Time Frame: Week 12 ]
    Clinical remission per adapted Mayo Score.


Secondary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants with Endoscopic Improvement [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.

  2. Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline [ Time Frame: Week 12 ]
    Clinical remission per Full Mayo Score.

  3. Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.

  4. Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score [ Time Frame: Clinical response per Partial Adapted Mayo Score (without endoscopy). ]
    Week 4

  5. Sub-Study 1: Percentage of Participants with Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.

  6. Sub-Study 1: Percentage of Participants with Hospitalization [ Time Frame: Through Week 12 ]
    Participants with an event that results in admission to the hospital.

  7. Sub-Study 1: Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]
    Mucosal healing defined as endoscopic and histologic remission.

  8. Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) [ Time Frame: Baseline Through Week 12 ]
    The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.

  9. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline Through Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  10. Sub-Study 1: Change in Short Form-36 (SF-36) [ Time Frame: Baseline Through Week 12 ]
    The SF-36 is an indicator of overall health status.

  11. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Baseline Through 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. Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC)-related Surgeries [ Time Frame: Through 12 weeks ]
    Participants who underwent surgery related to UC.

  13. Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline [ Time Frame: Week 12 ]
    Clinical remission per Full Mayo Score.

  14. Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.

  15. Sub-Study 2: Percentage of Participants who Reported No Abdominal Pain [ Time Frame: Week 12 ]
    Percentage of participants who reported no abdominal pain.

  16. Sub-Study 2: Percentage of Participants who Reported No Bowel Urgency [ Time Frame: Week 12 ]
    Percentage of participants who reported no bowel urgency.

  17. Sub-Study 2: Percentage of Participants with Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.

  18. Sub-Study 2: Percentage of Participants with Endoscopic Improvement [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.

  19. Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline Through Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  20. Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Baseline Through 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.

  21. Sub-Study 2: Percentage of Participants with Histological Endoscopic Improvement of the Mucosa [ Time Frame: Week 12 ]
    Percentage of participants with histological endoscopic improvement of the mucosa.

  22. Sub-Study 2: Percentage of Participants who Reported No Nocturnal Bowel Movements [ Time Frame: Week 12 ]
    Percentage of participants who reported no nocturnal bowel movements.

  23. Sub-Study 2: Percentage of Participants who Reported No Tenesmus [ Time Frame: Week 12 ]
    Percentage of participants who reported no tenesmus.

  24. Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week [ Time Frame: Baseline Through Week 12 ]
    Change in number of fecal incontinence episodes per week.

  25. Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms [ Time Frame: Baseline Through Week 12 ]
    Change in number of days per week with sleep interrupted due to UC symptoms.

  26. Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score in Participants with Pancolitis at Baseline [ Time Frame: Week 12 ]
    Clinical response per partial adapted Mayo Score (without endoscopy), in participants with pancolitis at Baseline.

  27. Sub-Study 2: Percentage of Participants with Ulcerative Colitis (UC)-related Hospitalization [ Time Frame: Through Week 12 ]
    Participants with an UC-related event that results in admission to the hospital.

  28. Sub-Study 2: Change in Short Form-36 (SF-36) [ Time Frame: Baseline Through Week 12 ]
    The SF-36 is an indicator of overall health status.


Eligibility Criteria
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Information from the National Library of Medicine

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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
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.
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03398148    
Other Study ID Numbers: M16-067
2016-004677-40 ( EudraCT Number )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
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, analyses plans, 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)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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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:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs