Trial Outcomes & Findings for Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis (NCT NCT01101100)
NCT ID: NCT01101100
Last Updated: 2019-07-30
Results Overview
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
264 weeks
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Open Label AMG 827
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
Overall Study
STARTED
|
181
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
Open Label
n=181 Participants
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
173 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 264 weeksPopulation: Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
Outcome measures
| Measure |
Open Label AMG 827
n=107 Participants
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
|
66 Participants
|
PRIMARY outcome
Timeframe: 264 weeksPopulation: Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.
Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Outcome measures
| Measure |
Open Label AMG 827
n=106 Participants
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
Percent Change in Psoriasis Area and Severity Index (PASI)
|
-85.7 Percentage change
Standard Deviation 26.3
|
Adverse Events
Open Label AMG 827
Serious events: 29 serious events
Other events: 177 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open Label AMG 827
n=181 participants at risk
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.55%
1/181
|
|
Cardiac disorders
Myocardial Infaraction
|
1.7%
3/181
|
|
Infections and infestations
Hepatitis C
|
0.55%
1/181
|
|
Infections and infestations
Meningitis Viral
|
0.55%
1/181
|
|
Infections and infestations
Pyelonephritis
|
0.55%
1/181
|
|
Infections and infestations
Pyelonephritis acute
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.55%
1/181
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.55%
1/181
|
|
Skin and subcutaneous tissue disorders
Pustular Psoriasis
|
1.7%
3/181
|
|
Skin and subcutaneous tissue disorders
Toxic Skin Eruptions
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.55%
1/181
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.55%
1/181
|
|
Cardiac disorders
Atrial fibrillation
|
0.55%
1/181
|
|
Cardiac disorders
Cardiac failure congestive
|
0.55%
1/181
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.55%
1/181
|
|
Infections and infestations
Abscess
|
0.55%
1/181
|
|
Infections and infestations
Necrotising fascitis streptococcal
|
0.55%
1/181
|
|
Infections and infestations
Septic Shock
|
0.55%
1/181
|
|
Infections and infestations
Urosepsis
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.55%
1/181
|
|
Gastrointestinal disorders
Gastroenteritis eosinophillic
|
0.55%
1/181
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
2/181
|
|
Musculoskeletal and connective tissue disorders
Intervertabral disc protrusion
|
0.55%
1/181
|
|
Hepatobiliary disorders
Bile duct stone
|
0.55%
1/181
|
|
Hepatobiliary disorders
Cholecystitis
|
0.55%
1/181
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.55%
1/181
|
|
Psychiatric disorders
Depression
|
1.1%
2/181
|
|
Psychiatric disorders
Suicidal ideation
|
0.55%
1/181
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.55%
1/181
|
|
Vascular disorders
Femoral artery occlusion
|
0.55%
1/181
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
1/181
|
Other adverse events
| Measure |
Open Label AMG 827
n=181 participants at risk
AMG 827: 210 mg SC or 140 mg SC
|
|---|---|
|
General disorders
Nasopharyngitis
|
29.3%
53/181
|
|
Infections and infestations
Upper respiratory tract infection
|
23.8%
43/181
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.4%
37/181
|
|
Infections and infestations
Influenza
|
15.5%
28/181
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.4%
26/181
|
|
Gastrointestinal disorders
Gastroenteritis
|
13.3%
24/181
|
|
Infections and infestations
Sinusitis
|
11.6%
21/181
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
10.5%
19/181
|
|
Nervous system disorders
Hypertension
|
9.9%
18/181
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.9%
18/181
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
9.9%
18/181
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
8.8%
16/181
|
|
General disorders
Pain in extremity
|
8.8%
16/181
|
|
Psychiatric disorders
Anxiety
|
8.3%
15/181
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.3%
15/181
|
|
Nervous system disorders
Headache
|
7.7%
14/181
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.2%
13/181
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
7.2%
13/181
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.6%
12/181
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
11/181
|
|
Gastrointestinal disorders
Nausea
|
6.1%
11/181
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.1%
11/181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
6.1%
11/181
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
10/181
|
|
General disorders
Fatigue
|
5.5%
10/181
|
|
General disorders
Insomnia
|
5.5%
10/181
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.5%
10/181
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.5%
10/181
|
|
Renal and urinary disorders
Urinary tract infection
|
5.5%
10/181
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.5%
10/181
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER