Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis (NCT NCT00975637)
NCT ID: NCT00975637
Last Updated: 2019-06-26
Results Overview
At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
210 mg
AMG 827: 210 mg SC
|
140 mg
AMG 827: 140 mg SC
|
280 mg
AMG 827: 280 mg SC
|
Placebo
Placebo: Placebo SC
|
70 mg
AMG 827: 70 mg SC
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
42
|
38
|
39
|
|
Overall Study
COMPLETED
|
37
|
38
|
40
|
32
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
Broda 210 mg
n=40 Participants
AMG 827: 210 mg SC
|
Broda 140 mg
n=39 Participants
AMG 827: 140 mg SC
|
Broda 280 mg
n=42 Participants
AMG 827: 280 mg SC
|
Placebo
n=38 Participants
Placebo: Placebo SC
|
Broda 70 mg
n=39 Participants
AMG 827: 70 mg SC
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
190 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
44.0 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
41.8 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 11.1 • n=31 Participants
|
42.6 years
STANDARD_DEVIATION 11.7 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
71 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
127 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
191 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksAt screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.
Outcome measures
| Measure |
Broda 210 mg
n=40 Participants
AMG 827: 210 mg SC
|
Broda 140 mg
n=39 Participants
AMG 827: 140 mg SC
|
Broda 280 mg
n=42 Participants
AMG 827: 280 mg SC
|
Placebo
n=38 Participants
Placebo: Placebo SC
|
Broda 70 mg
n=39 Participants
AMG 827: 70 mg SC
|
|---|---|---|---|---|---|
|
Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
|
86.3 percentage of psoriasis improvement
Standard Deviation 27.6
|
85.9 percentage of psoriasis improvement
Standard Deviation 22.5
|
76 percentage of psoriasis improvement
Standard Deviation 32.7
|
16 percentage of psoriasis improvement
Standard Deviation 27
|
45 percentage of psoriasis improvement
Standard Deviation 41.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred.
Outcome measures
| Measure |
Broda 210 mg
n=40 Participants
AMG 827: 210 mg SC
|
Broda 140 mg
n=39 Participants
AMG 827: 140 mg SC
|
Broda 280 mg
n=42 Participants
AMG 827: 280 mg SC
|
Placebo
n=38 Participants
Placebo: Placebo SC
|
Broda 70 mg
n=39 Participants
AMG 827: 70 mg SC
|
|---|---|---|---|---|---|
|
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis
|
22.1 percentage improvement in BSA
Standard Deviation 15.0
|
21.1 percentage improvement in BSA
Standard Deviation 16.9
|
16.1 percentage improvement in BSA
Standard Deviation 11.4
|
0.9 percentage improvement in BSA
Standard Deviation 9.7
|
9.2 percentage improvement in BSA
Standard Deviation 11.2
|
Adverse Events
Broda 210 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Broda 140 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Broda 280 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Broda 70 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Broda 210 mg
n=40 participants at risk
AMG 827: 210 mg SC
|
Broda 140 mg
n=39 participants at risk
AMG 827: 140 mg SC
|
Broda 280 mg
n=42 participants at risk
AMG 827: 280 mg SC
|
Placebo
n=38 participants at risk
Placebo: Placebo SC
|
Broda 70 mg
n=39 participants at risk
AMG 827: 70 mg SC
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
Other adverse events
| Measure |
Broda 210 mg
n=40 participants at risk
AMG 827: 210 mg SC
|
Broda 140 mg
n=39 participants at risk
AMG 827: 140 mg SC
|
Broda 280 mg
n=42 participants at risk
AMG 827: 280 mg SC
|
Placebo
n=38 participants at risk
Placebo: Placebo SC
|
Broda 70 mg
n=39 participants at risk
AMG 827: 70 mg SC
|
|---|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
7.5%
3/40
|
2.6%
1/39
|
9.5%
4/42
|
2.6%
1/38
|
2.6%
1/39
|
|
General disorders
Injection Site Pain
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
7.7%
3/39
|
|
General disorders
Fatigue
|
5.0%
2/40
|
5.1%
2/39
|
0.00%
0/42
|
0.00%
0/38
|
2.6%
1/39
|
|
General disorders
Injection Site Induration
|
2.5%
1/40
|
0.00%
0/39
|
4.8%
2/42
|
0.00%
0/38
|
0.00%
0/39
|
|
General disorders
Injection Site Swelling
|
2.5%
1/40
|
2.6%
1/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/40
|
2.6%
1/39
|
2.4%
1/42
|
2.6%
1/38
|
0.00%
0/39
|
|
General disorders
Injection Site Hematoma
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
2.6%
1/39
|
|
General disorders
Injection Site Uticaria
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
General disorders
Injection Site Warmth
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
General disorders
Chills
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
2.6%
1/38
|
0.00%
0/39
|
|
General disorders
Oedema Peripheral
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
2.6%
1/38
|
0.00%
0/39
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40
|
2.6%
1/39
|
2.4%
1/42
|
0.00%
0/38
|
5.1%
2/39
|
|
Infections and infestations
Furuncle
|
2.5%
1/40
|
2.6%
1/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
2.6%
1/38
|
2.6%
1/39
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
5.1%
2/39
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
2.6%
1/39
|
|
Infections and infestations
Pharnyngitis
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Infections and infestations
Sinustitis
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
2.6%
1/38
|
0.00%
0/39
|
|
Infections and infestations
Viral Infection
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40
|
0.00%
0/39
|
2.4%
1/42
|
2.6%
1/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Mechanical Urticaria
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Rash Morbilliform
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/42
|
0.00%
0/38
|
0.00%
0/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place