Psoriasis
Conditions
Keywords
psoriasis, brodalumab (AMG 827)
Brief summary
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
Detailed description
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.
Interventions
210 mg brodalumab administered subcutaneous (SC)
140 mg brodalumab administered subcutaneous (SC)
DRUGplacebo
Placebo administered subcutaneous (SC)
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject has had stable moderate to severe plaque psoriasis for at least 6 months * Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling * Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline
Exclusion criteria
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations * Subject has known history of Crohn's disease * Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol * Subject has stopped using certain psoriasis therapies as defined in the study protocol * Subject has previously used any anti-IL-17 biologic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | 0-12 weeks | to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12. |
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 0 - 12 Weeks | To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear \[0\] or almost clear \[1\]) on the static physicians global assessment (sPGA) at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | Week 0 - Week 52 | to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear\[0\] or almost clear \[1\]) at week 52. |
Countries
Canada, France, Germany, Poland, Switzerland, United States
Participant flow
Pre-assignment details
Total number should be calculated from the induction phase at 661 subjects starting the study. At week 12 if subjects achieved sPGA success (clear\[0\] or almost clear\[1\]) they were not continued in the study withdrawal phase to receive drug. Those not achieving success were re-randomized for treatment continuation.
Participants by arm
| Arm | Count |
|---|---|
| 210 mg Brodalumab Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC) | 222 |
| 140 mg Brodalumab Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC) | 219 |
| Placebo Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC) | 220 |
| Total | 661 |
Baseline characteristics
| Characteristic | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 12.2 | 45.8 years STANDARD_DEVIATION 13.4 | 46.9 years STANDARD_DEVIATION 13.2 | 46.3 years STANDARD_DEVIATION 12.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 10 Participants | 8 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 203 Participants | 196 Participants | 202 Participants | 601 Participants |
| Sex: Female, Male Female | 61 Participants | 57 Participants | 59 Participants | 177 Participants |
| Sex: Female, Male Male | 161 Participants | 162 Participants | 161 Participants | 484 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 85 / 222 | 91 / 219 | 46 / 220 |
| serious Total, serious adverse events | 4 / 222 | 6 / 219 | 3 / 220 |
Outcome results
Primary
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
Time frame: 0-12 weeks
Population: Data collected is based off of the data from the induction phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Phase: 210 mg Brodalumab | Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | 185 Participants |
| Induction Phase: 140 mg Brodalumab | Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | 132 Participants |
| Induction Phase: Placebo | Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | 6 Participants |
Primary
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear \[0\] or almost clear \[1\]) on the static physicians global assessment (sPGA) at week 12
Time frame: 0 - 12 Weeks
Population: Data reported is based off of the data collected from the induction phase
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Phase: 210 mg Brodalumab | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 168 Participants |
| Induction Phase: 140 mg Brodalumab | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 118 Participants |
| Induction Phase: Placebo | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 3 Participants |
Secondary
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear\[0\] or almost clear \[1\]) at week 52.
Time frame: Week 0 - Week 52
Population: Only subjects with efficacy data available at Week 52 were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Phase: 210 mg Brodalumab | Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | 3 Participants |
| Induction Phase: 140 mg Brodalumab | Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | 40 Participants |
| Induction Phase: Placebo | Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | 0 Participants |
| Withdrawl Phase: 210mg Brodalumab Q2W | Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | 69 Participants |