Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
Detailed description
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.
Interventions
DRUGAMG 827
210 mg SC or 140 mg SC
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject was randomized into Study 20090062 and completed the week 16 evaluation.
Exclusion criteria
* Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP. * Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | 264 weeks | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) |
| Percent Change in Psoriasis Area and Severity Index (PASI) | 264 weeks | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. |
Countries
Australia, Canada, Denmark, France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label AMG 827: 210 mg SC or 140 mg SC | 181 |
| Total | 181 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 173 Participants |
| Age, Continuous | 42.7 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 181 |
| other Total, other adverse events | 177 / 181 |
| serious Total, serious adverse events | 29 / 181 |
Outcome results
Primary
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
Time frame: 264 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label AMG 827 | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | 66 Participants |
Primary
Percent Change in Psoriasis Area and Severity Index (PASI)
Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Time frame: 264 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label AMG 827 | Percent Change in Psoriasis Area and Severity Index (PASI) | -85.7 Percentage change | Standard Deviation 26.3 |