Clinical trial NCT03448081: Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Psoriasis
Lead sponsor: Sienna Labs
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
timeFrame: week 8
Secondary outcomes:
measure: Change in Investigator Global Assessment (IGA) from baseline
timeFrame: week 8
measure: Change in Psoriasis Area Severity Index (PASI) from baseline
timeFrame: week 8
Other outcomes:
measure: Safety measured by frequency of Adverse Events
timeFrame: week 10
measure: Safety measured by severity of Adverse Events
timeFrame: week 10
measure: Safety measured by change in clinical lab results from baseline
timeFrame: week 10
measure: Safety measured by change in clinical lab results from baseline
timeFrame: week 10
measure: Safety measured by change in clinical lab results from baseline
timeFrame: week 10
measure: Safety measured by change from baseline in blood pressure
timeFrame: week 10
measure: Safety measured by change from baseline in pulse
timeFrame: week 10
measure: Safety measured by number of abnormal physical examinations from baseline
timeFrame: week 8
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week -4
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 0
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 4
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 8
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week -4
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 0
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 4
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 8
measure: Safety measured by QT intervals measured by 12-lead ECG
timeFrame: week -4
measure: Safety measured by QT intervals measured by 12-lead ECG
timeFrame: week 0
measure: Safety measured by QT intervals measured by 12-lead ECG
timeFrame: week 4
measure: Safety measured by QT intervals measured by 12-lead ECG
timeFrame: week 8
Locations:
city: Anniston
country: United States
facility: Sienna 018
state: Alabama
city: Mobile
country: United States
facility: Sienna 009
state: Alabama
city: Fountain Valley
country: United States
facility: Sienna 019
state: California
city: Los Angeles
country: United States
facility: Sienna 007
state: California
city: Sherman Oaks
country: United States
facility: Site 016
state: California
city: Coral Gables
country: United States
facility: Site 013
state: Florida
city: Sanford
country: United States
facility: Site 015
state: Florida
city: Indianapolis
country: United States
facility: Site 012
state: Indiana
city: Warren
country: United States
facility: Sienna 011
state: Michigan
city: Berlin
country: United States
facility: Sienna 005
state: New Jersey
city: Rochester
country: United States
facility: Sienna 020
state: New York
city: Raleigh
country: United States
facility: Site 014
state: North Carolina
city: Oklahoma City
country: United States
facility: Sienna 002
state: Oklahoma
city: Austin
country: United States
facility: Sienna 017
state: Texas
city: Houston
country: United States
facility: Sienna 010
state: Texas
city: Pflugerville
country: United States
facility: Sienna 021
state: Texas
city: San Antonio
country: United States
facility: Sienna 001
state: Texas
city: Surrey
country: Canada
facility: Sienna 006
state: British Columbia
city: Peterborough
country: Canada
facility: Sienna 008
state: Ontario
city: Montreal
country: Canada
facility: Sienna 003
state: Quebec
Study officials:
References: