Chronic Plaque Psoriasis
Conditions
Keywords
Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
Brief summary
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
Interventions
BIOLOGICALAIN457
BIOLOGICALPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion: 1. Coverage of the body surface area (BSA) of 10% or more with plaques 2. A score of 3 or more on the IGA (Investigator Global Assessment) scale 3. A PASI score of at least 12 at baseline;
Exclusion criteria
* Have forms of psoriasis other than the required plaque psoriasis * Women of childbearing potential * Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required) * Previous treatment with this investigational drug * Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores | baseline, week 4 | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PASI | baseline, weeks 12, 14, 16, 20, 24, 28 and 32 | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. |
| Investigator Global Assessment (IGA) Scores | baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32 | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. |
Countries
United States
Participant flow
Recruitment details
A total of 80 participants were enrolled into the study. However, due to audit findings at one site, all 65 participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. The safety set included participants from all other sites.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 0.3 mg/kg Participants received AIN457 0.3 mg/kg IV on Day 1. | 2 |
| AIN457 1.0 mg/kg Participants received AIN457 1.0 mg/kg IV on Day 1. | 4 |
| AIN457 3.0 mg/kg Participants received AIN457 3.0 mg/kg IV on Day 1. | 4 |
| Placebo Participants received placebo to AIN457A IV on day 1. | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Excluded Set | Administrative problems | 14 | 12 | 12 | 10 |
| Excluded Set | Withdrawal by Subject | 1 | 1 | 2 | 3 |
| Safety Set | Protocol deviation | 0 | 0 | 1 | 0 |
| Safety Set | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AIN457 0.3 mg/kg | AIN457 1.0 mg/kg | AIN457 3.0 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 9.19 | 53.3 Years STANDARD_DEVIATION 11.79 | 51.5 Years STANDARD_DEVIATION 8.35 | 52.4 Years STANDARD_DEVIATION 14.05 | 52.5 Years STANDARD_DEVIATION 10.38 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 20 | 4 / 20 | 5 / 20 | 3 / 20 |
| serious Total, serious adverse events | 1 / 20 | 1 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, week 4
Secondary
Change From Baseline in PASI
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Secondary
Investigator Global Assessment (IGA) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32