Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease (NCT NCT02633020)
NCT ID: NCT02633020
Last Updated: 2019-12-27
Results Overview
The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1). Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline and week 12
Results posted on
2019-12-27
Participant Flow
This study was conducted at 6 sites in France, Netherlands, Finland, Spain, and the United States. Participants with previously confirmed diagnosis of refractory coeliac disease (RCD) type 2 were enrolled from April 13, 2016 to January 19, 2017.
Participants were randomized in a 2:1 ratio to receive either 8 mg/kg AMG 714 or placebo. Randomization and initial dosing of the first 10 participants were staggered to allow observation for any possible unanticipated side effects.
Participant milestones
| Measure |
AMG 714
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
9
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
AMG 714
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded.
Baseline characteristics by cohort
| Measure |
AMG 714
n=19 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 10.2 • n=19 Participants
|
68.4 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
64.8 years
STANDARD_DEVIATION 10.5 • n=28 Participants
|
|
Age, Customized
18 - 64 years
|
12 Participants
n=19 Participants
|
2 Participants
n=9 Participants
|
14 Participants
n=28 Participants
|
|
Age, Customized
65 - 84 years
|
7 Participants
n=19 Participants
|
7 Participants
n=9 Participants
|
14 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=19 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=19 Participants
|
3 Participants
n=9 Participants
|
14 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=19 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=19 Participants
|
7 Participants
n=9 Participants
|
26 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=19 Participants
|
9 Participants
n=9 Participants
|
28 Participants
n=28 Participants
|
|
Percentage of Aberrant Intestinal Intraepithelial Lymphocytes (IELs) Versus Total IELs
|
62.86 percentage of aberrant IELs
STANDARD_DEVIATION 24.889 • n=14 Participants • The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded.
|
57.60 percentage of aberrant IELs
STANDARD_DEVIATION 22.199 • n=8 Participants • The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded.
|
60.94 percentage of aberrant IELs
STANDARD_DEVIATION 23.55 • n=22 Participants • The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded.
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded from analyses of Immunological Response 1.
The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1). Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+).
Outcome measures
| Measure |
AMG 714
n=14 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=8 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
|
2.45 percent change
Standard Error 8.83
|
7.30 percent change
Standard Error 11.70
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded from analyses of Immunological Response 2.
Percent change from baseline in the percentage of aberrant intestinal IELs with respect to intestinal epithelial cells (Immunological Response 2) is a composite endpoint calculated by multiplying the percent of aberrant IEL versus total IELs (per flow cytometry) by the percent of total IEL versus intestinal epithelial cells as assessed by immunohistochemistry.
Outcome measures
| Measure |
AMG 714
n=14 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=8 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells
|
11.66 percent change
Standard Error 15.79
|
49.88 percent change
Standard Error 21.33
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol population
Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease and increases in the VH:CD ratio indicate an improvement in the histology of intestinal mucosa (Histological Response). Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
Outcome measures
| Measure |
AMG 714
n=17 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio
|
26.44 percent change
Standard Error 14.06
|
15.77 percent change
Standard Error 19.36
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol population
The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline.
Outcome measures
| Measure |
AMG 714
n=17 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percentage of Participants With Improvement in Marsh Score at Week 12
|
35.3 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The per protocol population
Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. The total IEL count is the density of IELs vs intestinal epithelial cells measured by immunohistochemistry.
Outcome measures
| Measure |
AMG 714
n=17 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12
|
26.84 percent change
Standard Error 17.90
|
39.57 percent change
Standard Error 24.95
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The intent-to-treat population consisted of all randomized participants who had received at least one dose of the study drug.
Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced by the participant on any given day, the participant was required to document this in the diary.
Outcome measures
| Measure |
AMG 714
n=19 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Number of Weekly Bowel Movements at Baseline and Week 12
Baseline
|
10.3 bowel movements per week
Standard Deviation 5.21
|
7.4 bowel movements per week
Standard Deviation 4.03
|
|
Number of Weekly Bowel Movements at Baseline and Week 12
Week 12
|
11.3 bowel movements per week
Standard Deviation 5.72
|
8.3 bowel movements per week
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population
The Bristol Stool Form Scale (BSFS) is a pictorial aid to help participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid). Diarrhoea was defined at least one BSFS score \>= 6 for the given week.
Outcome measures
| Measure |
AMG 714
n=19 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Percentage of Participants With Diarrhea at Baseline and Week 12
Baseline
|
52.6 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Diarrhea at Baseline and Week 12
Week 12
|
36.8 percentage of participants
|
44.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population with available data.
The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes).
Outcome measures
| Measure |
AMG 714
n=18 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=8 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
|
-0.14 units on a scale
Standard Error 0.13
|
0.20 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population with available data.
The CeD-GSRS score is derived from a subset of 10 questions from the GSRS questionnaire (questions 1, 4-9, 11, 12 and 14), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort). The total CeD-GSRS score ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes).
Outcome measures
| Measure |
AMG 714
n=18 Participants
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=8 Participants
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
|
-0.14 units on a scale
Standard Error 0.16
|
0.17 units on a scale
Standard Error 0.24
|
Adverse Events
AMG 714
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 714
n=19 participants at risk
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 participants at risk
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumococcal infection
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tuberculosis
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Balance disorder
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebellar syndrome
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
AMG 714
n=19 participants at risk
Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
Placebo
n=9 participants at risk
Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye swelling
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual impairment
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lip dry
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lip exfoliation
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis viral
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Conjunctivitis
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
42.1%
8/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase abnormal
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Bacterial test
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood urine present
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Eosinophil count abnormal
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Eosinophil count increased
|
15.8%
3/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Helicobacter test positive
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Protein total decreased
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
3/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness postural
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Sleep disorder
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
5.3%
1/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/19 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • From first dose of study drug until week 16.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER