Psoriasis
Conditions
Brief summary
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
Detailed description
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
Interventions
DRUG70 mg SC
70 mg SC
DRUG210 mg SC
210 mg SC
DRUG140 mg SC
140 mg SC
DRUG280 mg SC
280 mg SC
DRUGPlacebo
Placebo SC
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject has had stable moderate to severe plaque psoriasis for at least 6 months * Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator. * Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Exclusion criteria
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis. * Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis. * Subject has any active CTCAE grade 2 or higher infection * Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. * Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids * Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies * Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines * Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose * Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Baseline and Week 12 | To 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Broda 210 mg AMG 827: 210 mg SC | 40 |
| Broda 140 mg AMG 827: 140 mg SC | 39 |
| Broda 280 mg AMG 827: 280 mg SC | 42 |
| Placebo Placebo: Placebo SC | 38 |
| Broda 70 mg AMG 827: 70 mg SC | 39 |
| Total | 198 |
Baseline characteristics
| Characteristic | Broda 210 mg | Broda 140 mg | Broda 280 mg | Placebo | Broda 70 mg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 38 Participants | 40 Participants | 35 Participants | 38 Participants | 190 Participants |
| Age, Continuous | 42.1 years STANDARD_DEVIATION 12.2 | 44.0 years STANDARD_DEVIATION 11.7 | 42.3 years STANDARD_DEVIATION 12.2 | 41.8 years STANDARD_DEVIATION 14.4 | 42.1 years STANDARD_DEVIATION 11.1 | 42.6 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 38 Participants | 41 Participants | 36 Participants | 38 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 12 Participants | 16 Participants | 17 Participants | 71 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 30 Participants | 22 Participants | 22 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 40 | 12 / 39 | 10 / 42 | 7 / 38 | 10 / 39 |
| serious Total, serious adverse events | 1 / 40 | 0 / 39 | 0 / 42 | 0 / 38 | 0 / 39 |
Outcome results
Primary
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
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Broda 210 mg | 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 |
| Broda 140 mg | 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 | 85.9 percentage of psoriasis improvement | Standard Deviation 22.5 |
| Broda 280 mg | 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 | 76 percentage of psoriasis improvement | Standard Deviation 32.7 |
| Placebo | 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 | 16 percentage of psoriasis improvement | Standard Deviation 27 |
| Broda 70 mg | 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 | 45 percentage of psoriasis improvement | Standard Deviation 41.7 |
Secondary
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis
To 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.
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Broda 210 mg | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | 22.1 percentage improvement in BSA | Standard Deviation 15 |
| Broda 140 mg | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | 21.1 percentage improvement in BSA | Standard Deviation 16.9 |
| Broda 280 mg | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | 16.1 percentage improvement in BSA | Standard Deviation 11.4 |
| Placebo | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | 0.9 percentage improvement in BSA | Standard Deviation 9.7 |
| Broda 70 mg | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | 9.2 percentage improvement in BSA | Standard Deviation 11.2 |