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PruritusPhase 2NCT03322137

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

A Phase 2 study testing SNA-120 in people with Pruritus and Psoriasis Vulgaris, run by Sienna Biopharmaceuticals at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pruritus, Psoriasis Vulgaris
What is being tested?
SNA-120
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
38 sitesUnited States
Study dates
10 Oct 2017to 22 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Sienna 013

    Albuquerque, New Mexico, 87106

  • Sienna 012

    Austin, Texas, 78759

  • Site 039

    Clarkston, Michigan, 48346

  • Sienna 021

    Dallas, Texas, 75246

  • Sienna 015

    Denver, Colorado, 80220

  • Site 026

    Doral, Florida, 33122

  • Sienna 004

    East Windsor, New Jersey, 08520

  • Sienna 005

    Farmington, Connecticut, 06032

  • Sienna 022

    Fort Smith, Arkansas, 72916

  • Site 028

    Fountain Valley, California, 92708

  • Sienna 009

    Fremont, California, 94538

  • Sienna 002

    Fridley, Minnesota, 55432

  • Sienna 016

    High Point, North Carolina, 27626

  • Sienna 018

    Houston, Texas, 77030

  • Sienna 019

    Largo, Florida, 33770

  • Sienna 023

    Louisville, Kentucky, 40202

  • Site 029

    Macon, Georgia, 31217

  • Site 038

    Metairie, Louisiana, 70006

  • Site 035

    Murfreesboro, Tennessee, 37130

  • Sienna 007

    Murray, Utah, 84107

  • Sienna 010

    New Albany, Indiana, 47150

  • Sienna 014

    Norfolk, Virginia, 23502

  • Site 041

    Norman, Oklahoma, 73071

  • Sienna 017

    North Miami Beach, Florida, 33162

  • Sienna 024

    Ocala, Florida, 34471

  • Site 034

    Pflugerville, Texas, 78660

  • Site 031

    Pittsburgh, Pennsylvania, 15213

  • Sienna 011

    Plainfield, Indiana, 46168

  • Sienna 003

    Portland, Oregon, 97223

  • Site 037

    Rochester, New York, 14623

  • Site 032

    Rockville, Maryland, 20850

  • Sienna 008

    San Diego, California, 92123

  • Sienna 020

    Santa Monica, California, 90404

  • Site 025

    Scottsdale, Arizona, 85255

  • Site 030

    Shelton, Connecticut, 06484

  • Sienna 001

    St Louis, Missouri, 63117

  • Site 027

    West Palm Beach, Florida, 33406

  • Sienna 006

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A 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

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.

Being tested
SNA-120, Vehicle
Medical subject headings
Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNA-120Drug

    Pegcantratinib ointment

  • VehicleDrug

    Placebo ointment to mimic Pegcantratinib ointment

Study groups in NCT03322137
Study groupRoleWhat they receive
SNA-120 (0.05% )Active comparatorPegcantratinib Ointment
Receives: Drug: SNA-120
SNA-120 (0.5%)Active comparatorPegcantratinib Ointment
Receives: Drug: SNA-120
VehiclePlacebo comparatorNot described
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: week 1

  2. Change in Itch Numeric Rating Scale scores (I-NRS)

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

    Measured: week 2

  3. Change in Itch Numeric Rating Scale scores (I-NRS)

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

    Measured: week 4

  4. Change in Itch Numeric Rating Scale scores (I-NRS)

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

    Measured: week 6

  5. Change in Itch Numeric Rating Scale scores (I-NRS)

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

    Measured: week 8

Secondary outcomes (4)

  1. Proportion of subjects (≥ 1 grade change) on IGA scale

    Investigator Global Assessment

    Measured: week 12

  2. Proportion of subjects (≥ 2 grade change) on IGA scale

    Investigator Global Assessment

    Measured: week 12

  3. Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories

    Investigator Global Assessment

    Measured: baseline and week 12

  4. Change in PASI-50

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

    Measured: baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start10 Oct 2017
  3. Primary completion10 Sep 2018
  4. Study completion22 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322137
Sponsor's protocol ID
SNA-120-201
Status last verified
Feb 2019
First submitted
4 Oct 2017
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SNA-120 in people with Pruritus and Psoriasis Vulgaris, run by Sienna Biopharmaceuticals at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Itch Numeric Rating Scale scores (I-NRS) (time frame: week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03322137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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