Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene

February 4, 2019 updated by: Sienna Biopharmaceuticals

An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Sienna 006
    • Ontario
      • Peterborough, Ontario, Canada, K9J 5K2
        • Sienna 008
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Sienna 003
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Sienna 018
      • Mobile, Alabama, United States, 36608
        • Sienna 009
    • California
      • Fountain Valley, California, United States, 92708
        • Sienna 019
      • Los Angeles, California, United States, 90045
        • Sienna 007
      • Sherman Oaks, California, United States, 91403
        • Site 016
    • Florida
      • Coral Gables, Florida, United States, 33143
        • Site 013
      • Sanford, Florida, United States, 32771
        • Site 015
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Site 012
    • Michigan
      • Warren, Michigan, United States, 48088
        • Sienna 011
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Sienna 005
    • New York
      • Rochester, New York, United States, 14623
        • Sienna 020
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Site 014
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Sienna 002
    • Texas
      • Austin, Texas, United States, 78745
        • Sienna 017
      • Houston, Texas, United States, 77004
        • Sienna 010
      • Pflugerville, Texas, United States, 78660
        • Sienna 021
      • San Antonio, Texas, United States, 78213
        • Sienna 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SNA-120 + Calcipotriene
Drug: SNA-120
SNA-120 (0.5%) active ointment
Drug: Calcipotriene
Calcipotriene ointment (0.005%)
Placebo Comparator: Placebo + Calcipotriene
Drug: Calcipotriene
Calcipotriene ointment (0.005%)
Drug: Placebo
Vehicle Ointment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
Time Frame: week 8
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Investigator Global Assessment (IGA) from baseline
Time Frame: week 8
5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)
week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
Time Frame: 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)
week 8

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety measured by frequency of Adverse Events
Time Frame: week 10
Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10
week 10
Safety measured by severity of Adverse Events
Time Frame: week 10
Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10
week 10
Safety measured by change in clinical lab results from baseline
Time Frame: week 10
biochemistry lab assessments
week 10
Safety measured by change in clinical lab results from baseline
Time Frame: week 10
Clinical laboratory assessments include urinalysis (pH, glucose, protein)
week 10
Safety measured by change in clinical lab results from baseline
Time Frame: week 10
hematology lab assessments
week 10
Safety measured by change from baseline in blood pressure
Time Frame: week 10
Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10
week 10
Safety measured by change from baseline in pulse
Time Frame: week 10
Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10
week 10
Safety measured by number of abnormal physical examinations from baseline
Time Frame: week 8
week 8
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame: week -4
Safety measured by PR/PQ intervals measured by 12-lead ECG at screening
week -4
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame: week 0
Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline
week 0
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame: week 4
Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4
week 4
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame: week 8
Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8
week 8
Safety measured by QRS duration measured by 12-lead ECG
Time Frame: week -4
Safety measured by QRS duration measured by 12-lead ECG at screening
week -4
Safety measured by QRS duration measured by 12-lead ECG
Time Frame: week 0
Safety measured by QRS duration measured by 12-lead ECG at baseline
week 0
Safety measured by QRS duration measured by 12-lead ECG
Time Frame: week 4
Safety measured by QRS duration measured by 12-lead ECG at week 4
week 4
Safety measured by QRS duration measured by 12-lead ECG
Time Frame: week 8
Safety measured by QRS duration measured by 12-lead ECG at week 8
week 8
Safety measured by QT intervals measured by 12-lead ECG
Time Frame: week -4
Safety measured by QT intervals measured by 12-lead ECG at screening
week -4
Safety measured by QT intervals measured by 12-lead ECG
Time Frame: week 0
Safety measured by QT intervals measured by 12-lead ECG at baseline
week 0
Safety measured by QT intervals measured by 12-lead ECG
Time Frame: week 4
Safety measured by QT intervals measured by 12-lead ECG at week 4
week 4
Safety measured by QT intervals measured by 12-lead ECG
Time Frame: week 8
Safety measured by QT intervals measured by 12-lead ECG at week 8
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sienna Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNA-120-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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