Adults 18 to 65, 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.
Percentage of Participants With Remission at Week 8Primary· Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on o
Unadjusted remission rate
Group
Value
95% CI
Placebo
13.3
Abrilumab 21 mg Q4W
23.1
Abrilumab 70 mg Q4W
14.3
Abrilumab 210 mg
19.5
Adjusted remission rate
Group
Value
95% CI
Placebo
12.8
Abrilumab 21 mg Q4W
23.1
Abrilumab 70 mg Q4W
14.4
Abrilumab 210 mg
21.9
Percentage of Participants With Remission at Week 12Secondary· Week 12
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed dat
Unadjusted remission rate
Group
Value
95% CI
Placebo
18.1
Abrilumab 21 mg Q4W
33.3
Abrilumab 70 mg Q4W
25.3
Abrilumab 210 mg
27.0
Adjusted remission rate
Group
Value
95% CI
Placebo
20.1
Abrilumab 21 mg Q4W
43.8
Abrilumab 70 mg Q4W
31.0
Abrilumab 210 mg
34.8
Percentage of Participants With Response at Week 12Secondary· Baseline and week 12
Response was defined as either remission (a CDAI score \< 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with
Unadjusted response rate
Group
Value
95% CI
Placebo
27.7
Abrilumab 21 mg Q4W
41.7
Abrilumab 70 mg Q4W
45.3
Abrilumab 210 mg
43.2
Adjusted response rate
Group
Value
95% CI
Placebo
35.3
Abrilumab 21 mg Q4W
50.4
Abrilumab 70 mg Q4W
55.1
Abrilumab 210 mg
50.9
Percentage of Participants With Response at Week 8Secondary· Baseline and week 8
Response was defined as either remission (a CDAI score \< 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with
Unadjusted response rate
Group
Value
95% CI
Placebo
26.4
Abrilumab 21 mg Q4W
33.3
Abrilumab 70 mg Q4W
42.9
Abrilumab 210 mg
30.6
Adjusted response rate
Group
Value
95% CI
Placebo
30.6
Abrilumab 21 mg Q4W
33.8
Abrilumab 70 mg Q4W
46.6
Abrilumab 210 mg
32.6
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24Secondary· Week 12 and week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity
Unadjusted remission rate
Group
Value
95% CI
Placebo
8.2
Abrilumab 21 mg Q4W
19.2
Abrilumab 70 mg Q4W
11.9
Abrilumab 210 mg
17.1
Adjusted remission rate
Group
Value
95% CI
Placebo
9.0
Abrilumab 21 mg Q4W
25.0
Abrilumab 70 mg Q4W
14.0
Abrilumab 210 mg
21.7
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24Secondary· Week 8 and week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Unadjusted remission rate
Group
Value
95% CI
Placebo
7.1
Abrilumab 21 mg Q4W
15.4
Abrilumab 70 mg Q4W
9.5
Abrilumab 210 mg
12.2
Adjusted remission rate
Group
Value
95% CI
Placebo
5.9
Abrilumab 21 mg Q4W
14.3
Abrilumab 70 mg Q4W
8.7
Abrilumab 210 mg
12.7
Change From Baseline in CDAI Score at Week 12Secondary· Baseline and week 12
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Group
Value
95% CI
Placebo
-55.32
± 11.41
Abrilumab 21 mg Q4W
-92.16
± 21.85
Abrilumab 70 mg Q4W
-97.41
± 12.92
Abrilumab 210 mg
-96.11
± 22.78
Change From Baseline in CDAI Score at Week 8Secondary· Baseline and week 8
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Group
Value
95% CI
Placebo
-64.05
± 9.62
Abrilumab 21 mg Q4W
-80.42
± 20.86
Abrilumab 70 mg Q4W
-91.52
± 11.78
Abrilumab 210 mg
-87.64
± 19.89
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Amgen
Last refreshed: 27 June 2019
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/NCT01696396.