Trial Outcomes & Findings for Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 (NCT NCT00867100)

Last Updated: 2019-01-16

Results Overview

Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

84 participants

Primary outcome timeframe

Through day 43

Results posted on

2019-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Part B Single SC or IV dose of matching placebo	Cohort 10: 140 mg Sc Part B 140 mg Sc PsO Population Adults with Psoriasis	Cohort 11: 350 mg Sc Part B 350 mg Sc PsO population Adults with Psoriasis	Cohort 9: 700 mg IV Part B 700 mg IV PsO population Adults with Psoriasis	Placebo Part A Single SC or IV dose of matching placebo	Cohort 1: 7mg SC Part A 7mg SC PsO population	Cohort 2: 21mg SC Part A 21mg SC PsO population	Cohort 3: 21mg IV Part A 21 mg IV PsO population	Cohort 4: 70mg SC Part A 70mg SC PsO population	Cohort 5: 210mg SC Part A 210mg SC PsO population	Cohort 6: 210mg IV Part A 210 mg IV PsO population	Cohort 7: 420mg SC Part A 420mg SC PsO Population	Cohort 8: 700mg IV Part A 700mg IV PsO population
Overall Study STARTED	5	5	8	8	14	6	7	3	6	6	4	6	6
Overall Study COMPLETED	5	4	8	8	14	6	6	3	6	6	3	6	6
Overall Study NOT COMPLETED	0	1	0	0	0	0	1	0	0	0	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Part B n=5 Participants Single SC or IV dose of matching placebo	140 mg SC Part B n=4 Participants 140 mg Sc PsO Population	350 mg SC Part B n=8 Participants 350 mg Sc PsO population	700 mg IV Part B n=8 Participants 700 mg IV PsO population	Placebo Part A n=14 Participants Single SC or IV dose of matching placebo	7mg SC Part A n=6 Participants 7mg SC PsO population	21mg SC Part A n=6 Participants 21mg SC PsO population	21mg IV Part A n=3 Participants 21mg IV PsO population	70mg SC Part A n=6 Participants 70mg SC Pso population	210mg SC Part A n=6 Participants 210mg SC PsO population	210mg IV Part A n=4 Participants 210mg IV PsO population	420mg SC Part A n=6 Participants 420mg SC PsO population	700mg IV Part A n=6 Participants 700mg IV PsO population	Total n=82 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 6.6 • n=5 Participants	34.5 years STANDARD_DEVIATION 11.7 • n=7 Participants	39.5 years STANDARD_DEVIATION 13.4 • n=5 Participants	43 years STANDARD_DEVIATION 11.6 • n=4 Participants	23.1 years STANDARD_DEVIATION 2.5 • n=21 Participants	25.5 years STANDARD_DEVIATION 8.2 • n=8 Participants	27.0 years STANDARD_DEVIATION 8.6 • n=8 Participants	25.3 years STANDARD_DEVIATION 2.5 • n=24 Participants	22.2 years STANDARD_DEVIATION 1.5 • n=42 Participants	28.3 years STANDARD_DEVIATION 9.9 • n=42 Participants	21.3 years STANDARD_DEVIATION 2.2 • n=42 Participants	24.5 years STANDARD_DEVIATION 6.6 • n=42 Participants	24.3 years STANDARD_DEVIATION 3.0 • n=36 Participants	32.75 years STANDARD_DEVIATION 9.05 • n=36 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	6 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=36 Participants	76 Participants n=36 Participants

PRIMARY outcome

Timeframe: Through day 43

Population: This PASI outcome measure data refers only to Part B subjects with moderate to severe plaque psoriasis.

Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Placebo-treated	140 mg Sc n=4 Participants 140 mg Sc PsO Population	350 mg Sc n=8 Participants 350 mg Sc PsO population	700 mg IV n=8 Participants 700 mg IV PsO population	Cohort 4: 70mg SC Part A 70mg SC PsO population	Cohort 5: 210mg SC Part A 210mg SC PsO population	Cohort 6: 210mg IV Part A 210 mg IV PsO population	Cohort 7: 420mg SC Part A 420mg SC PsO Population	Cohort 8: 700mg IV Part A 700mg IV PsO population
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	19.88 percentage improvement Standard Deviation 6.36	17.74 percentage improvement Standard Deviation 15.34	53.57 percentage improvement Standard Deviation 30.45	86.04 percentage improvement Standard Deviation 8.70	—	—	—	—	—

PRIMARY outcome

Timeframe: 85 days

This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Placebo-treated	140 mg Sc n=4 Participants 140 mg Sc PsO Population	350 mg Sc n=8 Participants 350 mg Sc PsO population	700 mg IV n=8 Participants 700 mg IV PsO population	Cohort 4: 70mg SC Part A 70mg SC PsO population	Cohort 5: 210mg SC Part A 210mg SC PsO population	Cohort 6: 210mg IV Part A 210 mg IV PsO population	Cohort 7: 420mg SC Part A 420mg SC PsO Population	Cohort 8: 700mg IV Part A 700mg IV PsO population
Part B: All Treatment Adverse Events Reported for Safety Evaluation	4 participants with events	3 participants with events	7 participants with events	8 participants with events	—	—	—	—	—

PRIMARY outcome

Timeframe: Cohort 1-4 43 days, Cohort 5-8 64 days

This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.