Pruritus, Psoriasis
Conditions
Brief summary
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
Detailed description
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
Interventions
DRUGSNA-120
SNA-120 (0.5%) active ointment
DRUGPlacebo
Vehicle Ointment
DRUGCalcipotriene
Calcipotriene ointment (0.005%)
Sponsors
Sienna Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Stable psoriasis for at least 6 months prior to screening * Chronic pruritus of the psoriasis plaques at least 6 weeks prior to screening * At least moderate baseline overall itch associated with psoriatic plaques * Willing and able to undergo a 4-week run-in with calcipotriene ointment dosing and remain on this stable regimen throughout the study * Mild or moderate psoriasis at screening and baseline * Subject's plaques are amenable to treatment with a topical medication * Willing and able to discontinue all other topical products to treat psoriasis and/or itch, including topical steroids * Willing and able to avoid prolonged exposure of the designated treatment plaques to ultraviolet (UV) radiation (natural and artificial) for the duration of the study * Women of childbearing potential must have a negative pregnancy test and must agree to use highly effective methods of contraception during the study * Men who engage in sexual activity that can result in fathering children must agree to use highly effective forms of contraception during the study
Exclusion criteria
* Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin * Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders * Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments * Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis * Subjects with a clinical diagnosis of bacterial infection of the skin * Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene * Known hypersensitivity to SNA-120 (pegcantratinib), calcipotriene, the study treatment excipients, and /or polyethylene glycol (PEG), or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation * Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days or 5 half-lives of investigational drug (whichever is longer) of baseline * Women who are pregnant or lactating, or are planning to become pregnant during the study * Subjects previously participating in any SNA-120 (and/or CT327 or pegcantratinib) clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Itch Numeric Rating Scale scores (I-NRS) from baseline | week 8 | 11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Global Assessment (IGA) from baseline | week 8 | 5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe) |
| Change in Psoriasis Area Severity Index (PASI) from baseline | week 8 | A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by change from baseline in blood pressure | week 10 | Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10 |
| Safety measured by change from baseline in pulse | week 10 | Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10 |
| Safety measured by number of abnormal physical examinations from baseline | week 8 | — |
| Safety measured by frequency of Adverse Events | week 10 | Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10 |
| Safety measured by QRS duration measured by 12-lead ECG | week -4 | Safety measured by QRS duration measured by 12-lead ECG at screening |
| Safety measured by QT intervals measured by 12-lead ECG | week -4 | Safety measured by QT intervals measured by 12-lead ECG at screening |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | week -4 | Safety measured by PR/PQ intervals measured by 12-lead ECG at screening |
| Safety measured by severity of Adverse Events | week 10 | Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10 |
| Safety measured by change in clinical lab results from baseline | week 10 | biochemistry lab assessments |
Countries
Canada, United States
Outcome results
None listed