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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT03398148
• Date of registration: 08/01/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific 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
• Date of first enrolment: March 7, 2018
• Target sample size: 1558
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03398148
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

American Samoa, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: risankizumab IV

Drug: placebo for risankizumab

Drug: risankizumab SC

Primary Outcome(s)

Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score [Time Frame: Week 12]

Secondary Outcome(s)

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

Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline Through Week 12]

Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score [Time Frame: Week 4]

Sub-Study 1: Percentage of Participants with Hospitalization [Time Frame: Through Week 12]

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

Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4 [Time Frame: Week 4]

Sub-Study 1: Change in Short Form-36 (SF-36) [Time Frame: Baseline Through Week 12]

Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries [Time Frame: Through Week 12]

Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time Frame: Baseline Through Week 12]

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement [Time Frame: Week 12]

Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements [Time Frame: Week 12]

Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission [Time Frame: Week 12]

Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) [Time Frame: Week 12]

Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score [Time Frame: Baseline to Week 12]

Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain [Time Frame: Week 12]

Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time Frame: Baseline to Week 12]

Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency [Time Frame: Week 12]

Sub-Study 2: Occurrence of UC-related Hospitalizations [Time Frame: Baseline Through Week 12]

Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement [Time Frame: Week 12]

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]

Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) [Time Frame: Baseline Through Week 12]

Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms [Time Frame: Baseline to Week 12]

Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission [Time Frame: Week 12]

Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 [Time Frame: Week 12]

Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week [Time Frame: Baseline to Week 12]

Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) [Time Frame: Week 12]

Sub-Study 2: Percentage of Participants Achieving No Tenesmus [Time Frame: Week 12]

Secondary ID(s)

2016-004677-40

M16-067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors