Psoriasis
Conditions
Brief summary
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
Detailed description
All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.
Interventions
BIOLOGICALSecukinumab
150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
BIOLOGICALPlacebo
Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)
Sponsors
Novartis Pharmaceuticals
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 No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score \> 10 at baseline. * Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline. Key
Exclusion criteria
* Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes). * Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start. * Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study. * Pregnancy, breast feeding or inadequate contraception (if necessary)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus Intensity Visual Analogue Scale Score at Week 32 | Week 32 | On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus. |
Countries
Germany
Participant flow
Pre-assignment details
Of the 132 subjects enrolled in the study, 130 entered the Run-In phase.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 | 42 |
| Placebo Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 | 38 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomized Withdrawal (Wk 16 to 32) | Lack of Efficacy | 0 | 2 | 6 |
| Randomized Withdrawal (Wk 16 to 32) | Subject/guardian decision | 0 | 1 | 2 |
| Randomized Withdrawal (Wk 16 to 32) | Withdrawal by Subject | 0 | 1 | 4 |
| Run-in Phase (Week 0 to 16) | Adverse Event | 1 | 0 | 0 |
| Run-in Phase (Week 0 to 16) | Death unrelated to study treatment | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Secukinumab | Placebo | Total |
|---|---|---|---|
| Age, Customized <65 | 37 Participants | 36 Participants | 73 Participants |
| Age, Customized >=65 | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 41 Participants | 0 Participants | 41 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 27 Participants | 22 Participants | 49 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 | 43 / 130 | 16 / 42 | 19 / 38 |
| serious Total, serious adverse events | 6 / 130 | 2 / 42 | 0 / 38 |
Outcome results
Primary
Pruritus Intensity Visual Analogue Scale Score at Week 32
On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.
Time frame: Week 32
Population: FAS-R, LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Pruritus Intensity Visual Analogue Scale Score at Week 32 | 8.8 Units on a scale | Standard Error 4.7 |
| Placebo | Pruritus Intensity Visual Analogue Scale Score at Week 32 | 27.1 Units on a scale | Standard Error 4.9 |
p-value: 0.005595% CI: [-31.01, -5.59]ANCOVA