A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004677-40-SE

Enrollment

1547

Registered

2018-04-16

Start date

2018-10-02

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB Current Sponsor code: ABBV-066 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female aged >=18 to =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Study M16-067 comprises two sub-studies: The objective of Sub-Study 1 are to characterize 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.;Secondary Objective: Not applicable;Primary end point(s): The achievement of clinical remission per Adapted Mayo score at Week 12.;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: Study M16-067 comprises two sub-studies: The objective of Sub-Study 1 are to characterize 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.;Secondary Objective: Not applicable;Primary end point(s): The achievement of clinical remission per Adapted Mayo score at Week 12.;Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): Sub-study 1 1. The achievement of endoscopic improvement at Week 12 2. The achievement of clinical remission per Full Mayo score (defined as a Full Mayo score = 2 with no subscore > 1) at Week 12 in subjects with a Full Mayo score of 6 to 12 at Baseline 3. The achievement of clinical response per Adapted Mayo score at Week 12 4. The achievement of clinical response per Partial Adapted Mayo score at Week 4 5. The achievement of endoscopic remission at Week 12 6. Occurrence of subjects with hospitalizations through Week 12 7. The achievement of HEMR at Week 12 8. Change from Baseline in UC-Symptom Questionnaire (UC-SQ) at Week 12 9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12. 10. Change from Baseline in Short Form-36 at Week 12. 11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) at Week 12. 12. UC-related surgeries through Week 12 Sub-study 2 1. The achievement of clinical response per Adapted Mayo score at Week 12 2. The achievement of endoscopic improvement at Week 12 3. The achievement of histologic endoscopic mucosal improvement (HEMI: Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score = 3.1) at Week 12 4. The achievement of endoscopic remission at Week 12 5. The achievement of clinical response per Partial Adapted Mayo score at Week 4 6. The achievement of no bowel urgency at Week 12 7. The achievement of no abdominal pain at Week 12 8. The achievement of histologic endoscopic mucosal remission (HEMR: Endoscopy subscore of 0 and Geboes score < 2.0) at Week 12 9. Change from Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) 10. Change from Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score 11. Occurrence of UC-related hospitalizations through Week 12 12. The achievement of no nocturnal bowel movements at Week 12 13. The achievement of no tenesmus a	—

Measure

Time frame

Secondary end point(s): Sub-study 1 1. The achievement of endoscopic improvement at Week 12 2. The achievement of clinical remission per Full Mayo score (defined as a Full Mayo score = 2 with no subscore > 1) at Week 12 in subjects with a Full Mayo score of 6 to 12 at Baseline 3. The achievement of clinical response per Adapted Mayo score at Week 12 4. The achievement of clinical response per Partial Adapted Mayo score at Week 4 5. The achievement of endoscopic remission at Week 12 6. Occurrence of subjects with hospitalizations through Week 12 7. The achievement of HEMR at Week 12 8. Change from Baseline in UC-Symptom Questionnaire (UC-SQ) at Week 12 9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12. 10. Change from Baseline in Short Form-36 at Week 12. 11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) at Week 12. 12. UC-related surgeries through Week 12 Sub-study 2 1. The achievement of clinical response per Adapted Mayo score at Week 12 2. The achievement of endoscopic improvement at Week 12 3. The achievement of histologic endoscopic mucosal improvement (HEMI: Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score = 3.1) at Week 12 4. The achievement of endoscopic remission at Week 12 5. The achievement of clinical response per Partial Adapted Mayo score at Week 4 6. The achievement of no bowel urgency at Week 12 7. The achievement of no abdominal pain at Week 12 8. The achievement of histologic endoscopic mucosal remission (HEMR: Endoscopy subscore of 0 and Geboes score < 2.0) at Week 12 9. Change from Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) 10. Change from Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score 11. Occurrence of UC-related hospitalizations through Week 12 12. The achievement of no nocturnal bowel movements at Week 12 13. The achievement of no tenesmus a

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Countries

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

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026