Phase 3
N=581
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
Ulcerative Colitis (UC)
Bottom Line
View on ClinicalTrials.gov: NCT03398148 ↗Enrolled (actual)
581
Serious AEs
5.8%
Results posted
Jan 2025
Primary outcome: Primary: Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score — 1; 7; 6; 6 Participants — p=0.0324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- risankizumab IV (Drug); placebo for risankizumab (Drug); risankizumab SC (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score |
1; 7; 6; 6; 42 | 0.0324 sig |
| PRIMARY Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score |
6.2; 20.3 | <0.0001 sig |
| SECONDARY Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement |
3; 15; 8; 9; 61 | 0.0028 sig |
| SECONDARY 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 |
— | — |
| SECONDARY Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score |
12; 26; 28; 31; 157 | 0.0022 sig |
| SECONDARY Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score |
15; 20; 28; 22; 148 | 0.1842 |
| SECONDARY Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission |
0; 5; 3; 5; 22 | 0.0192 sig |
| SECONDARY Sub-Study 1: Percentage of Participants With Hospitalization |
5; 6; 4; 3; 19 | 0.7737 |
| SECONDARY Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) |
0; 3; 2; 1; 10 | 0.0722 |
| SECONDARY Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) |
-7.4; -13.8; -15.6; -15.1; -17.1 | 0.0030 sig |
| SECONDARY Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) |
20.1; 37.4; 40.3; 40.0; 49.5 | 0.0081 sig |
| SECONDARY Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component |
3.904; 5.112; 6.350; 6.296; 7.719 | 0.3315 |
| SECONDARY Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component |
3.094; 6.756; 7.284; 5.442; 7.777 | 0.0367 sig |
| SECONDARY Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) |
3.7; 7.6; 9.0; 8.3; 10.7 | 0.0422 sig |
| SECONDARY Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries |
0; 1; 0; 0; 7 | 1 |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score |
35.7; 64.3 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement |
12.1; 36.5 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) |
7.7; 24.5 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission |
3.4; 10.6 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4 |
30.5; 52.2 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency |
27.7; 44.1 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain |
26.5; 35.8 | 0.0021 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 |
0.6; 6.3 | <0.0001 sig |
| SECONDARY Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) |
3.3; 7.9 | <0.0001 sig |
| SECONDARY Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
24.3; 42.6 | <0.0001 sig |
| SECONDARY Sub-Study 2: Occurrence of UC-related Hospitalizations |
5.5; 0.8 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements |
43.1; 67.3 | <0.0001 sig |
| SECONDARY Sub-Study 2: Percentage of Participants Achieving No Tenesmus |
30.2; 48.7 | <0.0001 sig |
| SECONDARY Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week |
-2.213; -3.839 | <0.0001 sig |
| SECONDARY Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms |
-1.505; -2.485 | <0.0001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03398148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.