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SNA-120

Phase 2

Pruritus | Small Molecules | Dermatology |Sienna Biopharmaceuticals, Inc.|Trials Updated: Feb 8, 2019

SNA-120 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment281

FDA Designations

No designations recorded

SNA-120 clinical trials

SNA-120 · 2 trials · 3 indications

Phase 2 2
NCT03448081Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With CalcipotrienePruritus
COMPLETED73 Analytics
NCT03322137Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis VulgarisPruritus
COMPLETED208 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
PruritusUnlock trial analytics
PHASE2COMPLETED
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
PruritusUnlock trial analytics

Study Endpoints

Primary Endpoints

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)

Change in Itch Numeric Rating Scale scores (I-NRS)
week 1

The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

Secondary Endpoints

Change in Investigator Global Assessment (IGA) from baseline
week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
week 8
Proportion of subjects (≥ 1 grade change) on IGA scale
week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SNA-120 + CalcipotrieneACTIVE_COMPARATOR -
Placebo + CalcipotrienePLACEBO_COMPARATOR -
SNA-120 (0.05% )ACTIVE_COMPARATORPegcantratinib Ointment
SNA-120 (0.5%)ACTIVE_COMPARATORPegcantratinib Ointment
VehiclePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SNA-120DRUGSNA-120 (0.5%) active ointment
PlaceboDRUGVehicle Ointment
CalcipotrieneDRUGCalcipotriene ointment (0.005%)
VehicleDRUGPlacebo ointment to mimic Pegcantratinib ointment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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-we...

Countries:United StatesCanada
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