Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease (NCT NCT02637141)
NCT ID: NCT02637141
Last Updated: 2019-12-03
Results Overview
Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. 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. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline and week 12
Results posted on
2019-12-03
Participant Flow
This study was conducted at three sites in Finland.
Participants who met the study entry criteria were randomized at a 1:1:1 ratio to receive 150 mg or 300 mg AMG 714 or placebo once every 2 weeks for a total of 6 administrations over a period of 10 weeks. Randomization was stratified by study site and sex.
Participant milestones
| Measure |
AMG 714 150 mg
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
20
|
|
Overall Study
Received Study Drug
|
22
|
21
|
19
|
|
Overall Study
COMPLETED
|
20
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
AMG 714 150 mg
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week.
Baseline characteristics by cohort
| Measure |
AMG 714 150 mg
n=22 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=22 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=20 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 15.5 • n=22 Participants
|
47.8 years
STANDARD_DEVIATION 15.1 • n=22 Participants
|
54.7 years
STANDARD_DEVIATION 14.9 • n=20 Participants
|
51.0 years
STANDARD_DEVIATION 15.2 • n=64 Participants
|
|
Age, Customized
18 - 64 years
|
17 Participants
n=22 Participants
|
20 Participants
n=22 Participants
|
12 Participants
n=20 Participants
|
49 Participants
n=64 Participants
|
|
Age, Customized
≥ 65 years
|
5 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=22 Participants
|
17 Participants
n=22 Participants
|
14 Participants
n=20 Participants
|
47 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
6 Participants
n=20 Participants
|
17 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
20 Participants
n=20 Participants
|
63 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
20 Participants
n=20 Participants
|
64 Participants
n=64 Participants
|
|
Small Intestinal Villous Height to Crypt Depth Ratio
|
2.12 ratio
STANDARD_DEVIATION 0.251 • n=15 Participants • The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week.
|
2.19 ratio
STANDARD_DEVIATION 0.343 • n=19 Participants • The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week.
|
2.19 ratio
STANDARD_DEVIATION 0.426 • n=15 Participants • The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week.
|
2.17 ratio
STANDARD_DEVIATION 0.341 • n=49 Participants • The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week.
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.
Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. 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. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
|
-62.66 percent change
Standard Error 5.39
|
-53.78 percent change
Standard Error 4.83
|
-60.17 percent change
Standard Error 5.22
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.
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. Increased intraepithelial lymphocytes is associated with celiac disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12
|
95.14 percent change
Standard Error 15.06
|
68.22 percent change
Standard Error 13.64
|
109.46 percent change
Standard Error 14.65
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.
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 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Number of Participants With Improvement in Marsh Score at Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol 1 population with available data
Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=18 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12
|
5019.77 percent change
Standard Error 1482.59
|
1562.42 percent change
Standard Error 784.83
|
617.53 percent change
Standard Error 866.44
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol 1 population with available data
Levels of serum anti-DGP antibodies (immunoglobulin A \[IgA\] and immunoglobulin G \[IgG\]) were determined using ELISA immunoassay.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=18 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12
Immunoglobulin A
|
43.19 kU/L
Standard Error 12.85
|
18.47 kU/L
Standard Error 10.70
|
25.38 kU/L
Standard Error 11.44
|
|
Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12
Immunoglobulin G
|
28.29 kU/L
Standard Error 21.45
|
17.98 kU/L
Standard Error 14.57
|
15.12 kU/L
Standard Error 16.02
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol 1 population with available data
Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=14 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Number of Weekly Bowel Movements at Baseline and Week 12
Week 12
|
9.3 bowel movements per week
Standard Deviation 2.58
|
11.5 bowel movements per week
Standard Deviation 5.25
|
11.6 bowel movements per week
Standard Deviation 3.99
|
|
Number of Weekly Bowel Movements at Baseline and Week 12
Baseline
|
8.9 bowel movements per week
Standard Deviation 3.66
|
10.2 bowel movements per week
Standard Deviation 3.96
|
9.6 bowel movements per week
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Per protocol 1 population
The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study 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 as at least one BSFS score \>= 6 for the given week.
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=15 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Number of Participants With Diarrhoea at Baseline and Week 12
Baseline
|
4 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Diarrhoea at Baseline and Week 12
Week 12
|
1 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Per protocol 1 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 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=14 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
|
4.14 percent change
Standard Error 9.01
|
14.96 percent change
Standard Error 8.17
|
17.58 percent change
Standard Error 8.93
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Per protocol 1 population with available data
The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort). The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes).
Outcome measures
| Measure |
AMG 714 150 mg
n=15 Participants
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
AMG 714 300 mg
n=19 Participants
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=14 Participants
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
|
0.65 units on a scale
Standard Error 1.52
|
1.77 units on a scale
Standard Error 1.37
|
3.41 units on a scale
Standard Error 1.52
|
Adverse Events
150 mg AMG 714
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
300 mg AMG 714
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
150 mg AMG 714
n=22 participants at risk
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
300 mg AMG 714
n=21 participants at risk
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
Placebo
n=19 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Eye disorders
Eye pain
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Eye disorders
Photopsia
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
2/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Abdominal distension
|
31.8%
7/22 • From first dose of study drug until week 16
|
19.0%
4/21 • From first dose of study drug until week 16
|
31.6%
6/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • From first dose of study drug until week 16
|
14.3%
3/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • From first dose of study drug until week 16
|
23.8%
5/21 • From first dose of study drug until week 16
|
21.1%
4/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Diarrhoea
|
22.7%
5/22 • From first dose of study drug until week 16
|
38.1%
8/21 • From first dose of study drug until week 16
|
31.6%
6/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Flatulence
|
13.6%
3/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Nausea
|
31.8%
7/22 • From first dose of study drug until week 16
|
19.0%
4/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Oesophagitis
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Oral disorder
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Oral pruritus
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Tongue eruption
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
15.8%
3/19 • From first dose of study drug until week 16
|
|
General disorders
Chest pain
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
General disorders
Chills
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
General disorders
Fatigue
|
9.1%
2/22 • From first dose of study drug until week 16
|
23.8%
5/21 • From first dose of study drug until week 16
|
26.3%
5/19 • From first dose of study drug until week 16
|
|
General disorders
Impaired healing
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
General disorders
Injection site reaction
|
36.4%
8/22 • From first dose of study drug until week 16
|
52.4%
11/21 • From first dose of study drug until week 16
|
26.3%
5/19 • From first dose of study drug until week 16
|
|
General disorders
Mucosal dryness
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
General disorders
Oedema peripheral
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
General disorders
Pyrexia
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Gastroenteritis
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Gingivitis
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Influenza
|
13.6%
3/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Nasopharyngitis
|
22.7%
5/22 • From first dose of study drug until week 16
|
33.3%
7/21 • From first dose of study drug until week 16
|
36.8%
7/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Oral herpes
|
0.00%
0/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Rhinitis
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Investigations
Blood albumin decreased
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Blood albumin increased
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Investigations
Blood calcium increased
|
0.00%
0/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Investigations
Blood potassium increased
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Investigations
Body temperature decreased
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Hepatic enzyme increased
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
Neutrophil count increased
|
4.5%
1/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
White blood cell count increased
|
4.5%
1/22 • From first dose of study drug until week 16
|
14.3%
3/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Investigations
White blood cells urine positive
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • From first dose of study drug until week 16
|
19.0%
4/21 • From first dose of study drug until week 16
|
15.8%
3/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • From first dose of study drug until week 16
|
9.5%
2/21 • From first dose of study drug until week 16
|
15.8%
3/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • From first dose of study drug until week 16
|
14.3%
3/21 • From first dose of study drug until week 16
|
15.8%
3/19 • From first dose of study drug until week 16
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • From first dose of study drug until week 16
|
33.3%
7/21 • From first dose of study drug until week 16
|
42.1%
8/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Migraine
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Polyneuropathy
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Presyncope
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Nervous system disorders
Tremor
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
1/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Eczema
|
18.2%
4/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
3/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
4/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
5.3%
1/19 • From first dose of study drug until week 16
|
|
Surgical and medical procedures
Lipoma excision
|
4.5%
1/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Vascular disorders
Haematoma
|
0.00%
0/22 • From first dose of study drug until week 16
|
0.00%
0/21 • From first dose of study drug until week 16
|
10.5%
2/19 • From first dose of study drug until week 16
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/22 • From first dose of study drug until week 16
|
4.8%
1/21 • From first dose of study drug until week 16
|
0.00%
0/19 • From first dose of study drug until week 16
|
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