Loading clinical trials...

Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03448081•Sienna Biopharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (20)

Sienna 018

Anniston, Alabama, United States

Sienna 009

Mobile, Alabama, United States

Sienna 019

Fountain Valley, California, United States

Sienna 007

Los Angeles, California, United States

Site 016

Sherman Oaks, California, United States

Site 013

Coral Gables, Florida, United States

Site 015

Sanford, Florida, United States

Site 012

Indianapolis, Indiana, United States

Sienna 011

Warren, Michigan, United States

Sienna 005

Berlin, New Jersey, United States

Key Dates

Start Date

February 12, 2018

Primary Completion Date

November 21, 2018

Completion Date

December 10, 2018

Last Updated

February 8, 2019

Enrollment

ACTUAL participants

Conditions

PruritusPsoriasis

Interventions

SNA-120

DRUG

Placebo

DRUG

Calcipotriene

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments