Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris

ID: NCT03322137
Status: Recruiting
Phase: Phase 2
Start Date: October 10, 2017
First Submitted: October 04, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Sienna Labs
Sponsors & Collaborators: Sienna Biopharmaceuticals
Location: United States
Conditions: Pruritus, Psoriasis Vulgaris
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Study Description

Brief Summary

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.

Detailed Description

Condition or disease Intervention/treatment Phase

Pruritus

Psoriasis Vulgaris

Drug: SNA-120
Other Names
Drug: Vehicle
Other Names
Phase 2

Tracking Information

First Submitted DateOctober 04, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateOctober 10, 2017
Anticipated Completion DateJuly 01, 2018
Actual Primary Completion DateJuly 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in Itch Numeric Rating Scale scores (I-NRS) [Time Frame: week 1]

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

  • Change in Itch Numeric Rating Scale scores (I-NRS) [Time Frame: week 2]

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

  • Change in Itch Numeric Rating Scale scores (I-NRS) [Time Frame: week 4]

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

  • Change in Itch Numeric Rating Scale scores (I-NRS) [Time Frame: week 6]

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

  • Change in Itch Numeric Rating Scale scores (I-NRS) [Time Frame: week 8]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Proportion of subjects (≥ 1 grade change) on IGA scale [Time Frame: week 12]

    Investigator Global Assessment

  • Proportion of subjects (≥ 2 grade change) on IGA scale [Time Frame: week 12]

    Investigator Global Assessment

  • Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories [Time Frame: baseline and week 12]

    Investigator Global Assessment

  • Change in PASI-50 [Time Frame: baseline and week 12]

    Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Phase 2b, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of SNA-120 (Pegcantratinib) Ointment in Subjects With Pruritus Associated With Psoriasis Vulgaris
Brief Summary

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
192
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Pruritus
Psoriasis Vulgaris
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: SNA-120

Pegcantratinib ointment

Other Names
Drug: Vehicle

Placebo ointment to mimic Pegcantratinib ointment

Other Names
Study Groups/Cohorts
SNA-120 (0.05% )
Pegcantratinib Ointment

SNA-120 (0.5%)
Pegcantratinib Ointment

Vehicle

Study Arms
Active Comparator SNA-120 (0.05% )
Pegcantratinib Ointment
Drug : SNA-120
Pegcantratinib ointment

Active Comparator SNA-120 (0.5%)
Pegcantratinib Ointment
Drug : SNA-120
Pegcantratinib ointment

Placebo Comparator Vehicle
Drug : Vehicle
Placebo ointment to mimic Pegcantratinib ointment

Arm Intervention/Treatment
Active Comparator SNA-120 (0.05% )
Pegcantratinib Ointment
Drug : SNA-120
Active Comparator SNA-120 (0.5%)
Pegcantratinib Ointment
Drug : SNA-120
Placebo Comparator Vehicle
Drug : Vehicle

Recruitment Information

Recruitment Status:Recruiting
Enrollment192
Completion DateJuly 01, 2018
Eligibility Criteria: Inclusion Criteria:
- Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Stable PV for at least 6 months prior to screening
- Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening
- Mild to moderate PV at screening and baseline
- Has a target plaque at baseline on the trunk and/or limbs
- Subject's plaques are amenable to treatment with a topical ointment medication
- Willing and able to comply with the study instructions and attend all scheduled study visits.
- Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation
- Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study
- Men who are sexually active and can father 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
- Positive hepatitis serology
- Thyroid abnormalities that may impact itching
- Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus
- Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
- Active psoriasis or itch affecting the palmar/plantar regions
- Subjects with a clinical diagnosis of bacterial infection of the skin
- Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome
- Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study
- Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that 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 of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)
- Female who is pregnant or lactating, or is planning to become pregnant during the study
- Subjects participating in any previous SNA-120 (and/or CT327) clinical studies
GenderAll
Age12 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03322137
Other Study ID Numbers
SNA-120-201
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sienna Biopharmaceuticals
Collaborators
Not Available
Investigators
Not Available