Adults 16 to 80, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical RemissionPrimary· Week 12
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Group
Value
95% CI
Placebo (Period 1)
24.6
18.2 – 31.0
Risankizumab 600mg (Period 1)
45.2
39.9 – 50.5
Risankizumab 1200mg (Period 1)
41.6
36.3 – 46.8
US Specific: Percentage of Participants With Endoscopic ResponsePrimary· Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Group
Value
95% CI
Placebo (Period 1)
12.0
7.2 – 16.8
Risankizumab 600mg (Period 1)
40.3
35.0 – 45.6
Risankizumab 1200mg (Period 1)
32.1
27.1 – 37.1
Global Outside of US: Percentage of Participants With Clinical RemissionPrimary· Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Group
Value
95% CI
Placebo (Period 1)
21.7
15.6 – 27.8
Risankizumab 600mg (Period 1)
43.5
38.2 – 48.8
Risankizumab 1200mg (Period 1)
41.0
35.8 – 46.2
Global Outside of US: Percentage of Participants With Endoscopic ResponsePrimary· Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Group
Value
95% CI
Placebo (Period 1)
12.0
7.2 – 16.8
Risankizumab 600mg (Period 1)
40.3
35.0 – 45.6
Risankizumab 1200mg (Period 1)
32.1
27.1 – 37.1
US Specific: Percentage of Participants With Clinical RemissionSecondary· Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Group
Value
95% CI
Placebo (Period 1)
21.7
15.6 – 27.8
Risankizumab 600mg (Period 1)
43.5
38.2 – 48.8
Risankizumab 1200mg (Period 1)
41.0
35.8 – 46.2
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical ResponseSecondary· Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Group
Value
95% CI
Placebo (Period 1)
25.2
18.7 – 31.6
Risankizumab 600mg (Period 1)
40.8
35.5 – 46.0
Risankizumab 1200mg (Period 1)
37.2
32.0 – 42.3
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical ResponseSecondary· Week 12
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Group
Value
95% CI
Placebo (Period 1)
36.7
29.6 – 43.9
Risankizumab 600mg (Period 1)
59.7
54.5 – 65.0
Risankizumab 1200mg (Period 1)
64.9
59.8 – 70.0
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-FatigueSecondary· Week 12
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Group
Value
95% CI
Placebo (Period 1)
6.0
4.4 – 7.7
Risankizumab 600mg (Period 1)
11.2
10.1 – 12.4
Risankizumab 1200mg (Period 1)
10.1
9.0 – 11.3
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical RemissionSecondary· Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Group
Value
95% CI
Placebo (Period 1)
10.3
5.8 – 14.8
Risankizumab 600mg (Period 1)
18.4
14.3 – 22.6
Risankizumab 1200mg (Period 1)
18.9
14.7 – 23.0
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic ResponseSecondary· Week 12
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Group
Value
95% CI
Placebo (Period 1)
5.7
2.3 – 9.2
Risankizumab 600mg (Period 1)
30.0
25.1 – 34.9
Risankizumab 1200mg (Period 1)
23.0
18.5 – 27.5
US Specific: Percentage of Participants With Stool Frequency (SF) RemissionSecondary· Week 12
Stool Frequency (SF) remission is defined as an average daily SF \<= 2.8 and not worse than baseline.
Group
Value
95% CI
Placebo (Period 1)
29.8
23.1 – 36.6
Risankizumab 600mg (Period 1)
54.2
48.8 – 59.5
Risankizumab 1200mg (Period 1)
54.0
48.7 – 59.3
US Specific: Percentage of Participants With Abdominal Pain (AP) RemissionSecondary· Week 12
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score \<= 1 and not worse than baseline.
Group
Value
95% CI
Placebo (Period 1)
38.5
31.2 – 45.7
Risankizumab 600mg (Period 1)
59.6
54.3 – 64.8
Risankizumab 1200mg (Period 1)
58.1
52.9 – 63.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03398148 — A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risan
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NCT03104413 — A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Dis
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 6 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03105128.