Trial Outcomes & Findings for Evaluation of AMG 714 for Vitiligo (NCT NCT04338581)

Last Updated: 2025-12-09

Results Overview

An F-VASI35 responder is defined as a participant who has at least 35% improvement from Baseline in the facial vitiligo area scoring index (F-VASI). F-VASI assesses the area of the face affected by vitiligo. F-VASI is determined by the product of the percent of vitiligo involvement (percent of body surface area \[BSA\]) and the degree of depigmentation estimated to the nearest of the following percentages: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The percentage of BSA (hand or thumb unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator. F-VASI has a possible range from 0 to 3.5, with higher scores indicating more severe disease. Participants missing the F-VASI assessment at Week 24 are imputed as F-VASI35 non-responders.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Week 24

Results posted on

2025-12-09

Participant Flow

Seven sites in the United States were activated. All seven sites randomized participants. The first site was activated in November 2020 and the last participant was randomized in May 2024.

Participant milestones

Participant milestones
Measure	AMG 714 Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.	Placebo Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.
Overall Study STARTED	40	20
Overall Study Received AMG 714	40	1
Overall Study Received Placebo	0	19
Overall Study COMPLETED	34	16
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG 714 Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.	Placebo Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.
Overall Study Lack of Efficacy	1	0
Overall Study Withdrawal by Subject	4	4
Overall Study Prohibited Medication	1	0

Baseline Characteristics

Evaluation of AMG 714 for Vitiligo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMG 714 n=40 Participants Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.	Placebo n=19 Participants Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.	Total n=59 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 12.75 • n=4 Participants	52.4 Years STANDARD_DEVIATION 14.40 • n=50 Participants	50.7 Years STANDARD_DEVIATION 13.23 • n=518 Participants
Sex: Female, Male Female	19 Participants n=4 Participants	9 Participants n=50 Participants	28 Participants n=518 Participants
Sex: Female, Male Male	21 Participants n=4 Participants	10 Participants n=50 Participants	31 Participants n=518 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=4 Participants	2 Participants n=50 Participants	7 Participants n=518 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=4 Participants	16 Participants n=50 Participants	51 Participants n=518 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	1 Participants n=50 Participants	1 Participants n=518 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Asian	3 Participants n=4 Participants	3 Participants n=50 Participants	6 Participants n=518 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Black or African American	3 Participants n=4 Participants	1 Participants n=50 Participants	4 Participants n=518 Participants
Race (NIH/OMB) White	27 Participants n=4 Participants	12 Participants n=50 Participants	39 Participants n=518 Participants
Race (NIH/OMB) More than one race	4 Participants n=4 Participants	0 Participants n=50 Participants	4 Participants n=518 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=4 Participants	3 Participants n=50 Participants	6 Participants n=518 Participants
Region of Enrollment United States	40 participants n=4 Participants	19 participants n=50 Participants	59 participants n=518 Participants
Vitiligo Type at Baseline Active Vitiligo	23 Participants n=4 Participants	11 Participants n=50 Participants	34 Participants n=518 Participants
Vitiligo Type at Baseline Stable Vitiligo	17 Participants n=4 Participants	8 Participants n=50 Participants	25 Participants n=518 Participants
F-VASI at Baseline	1.154 Score on a Scale STANDARD_DEVIATION 0.8982 • n=4 Participants	1.035 Score on a Scale STANDARD_DEVIATION 0.9513 • n=50 Participants	1.116 Score on a Scale STANDARD_DEVIATION 0.9091 • n=518 Participants
T-VASI at Baseline	19.901 Score on a Scale STANDARD_DEVIATION 21.4012 • n=4 Participants	18.884 Score on a Scale STANDARD_DEVIATION 15.0015 • n=50 Participants	19.573 Score on a Scale STANDARD_DEVIATION 19.4434 • n=518 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo.

Outcome measures

Outcome measures
Measure	AMG 714 n=40 Participants Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.	Placebo n=19 Participants Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.
Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24	0.150 Proportion of participants Interval 0.057 to 0.298	0.053 Proportion of participants Interval 0.001 to 0.26

Adverse Events

AMG 714

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	AMG 714 n=41 participants at risk Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. Any participant receiving at least one injection of AMG 714 at any time during the study will be summarized with the AMG 714 treatment arm.	Placebo n=18 participants at risk Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10.
Blood and lymphatic system disorders Anaemia	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Blood and lymphatic system disorders Leukopenia	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Blood and lymphatic system disorders Neutropenia	7.3% 3/41 • Number of events 5 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Eye disorders Ocular discomfort	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Gastrointestinal disorders Inguinal hernia	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
General disorders Asthenia	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
General disorders Fatigue	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
General disorders Hypothermia	4.9% 2/41 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
General disorders Influenza like illness	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations COVID-19	7.3% 3/41 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	11.1% 2/18 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Gastrointestinal bacterial overgrowth	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Gastrointestinal infection	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Helicobacter infection	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Nasopharyngitis	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Postoperative wound infection	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Infections and infestations Sinusitis	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Exposure to toxic agent	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Joint injury	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Limb injury	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Nail injury	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Radiation injury	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Rib fracture	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Injury, poisoning and procedural complications Scapula fracture	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Aspartate aminotransferase increased	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Blood albumin decreased	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Blood bilirubin increased	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Lymphocyte count decreased	4.9% 2/41 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Neutrophil count decreased	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Weight decreased	4.9% 2/41 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Investigations Weight increased	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoid tumour	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Nervous system disorders Headache	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	0.00% 0/18 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/41 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	5.6% 1/18 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
Vascular disorders Hypertension	7.3% 3/41 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.	11.1% 2/18 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48. Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.