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
1 other identifier
interventional
73
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedFebruary 8, 2019
February 1, 2019
9 months
February 14, 2018
February 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
week 8
Secondary Outcomes (2)
Change in Investigator Global Assessment (IGA) from baseline
week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
week 8
Other Outcomes (20)
Safety measured by frequency of Adverse Events
week 10
Safety measured by severity of Adverse Events
week 10
Safety measured by change in clinical lab results from baseline
week 10
- +17 more other outcomes
Study Arms (2)
SNA-120 + Calcipotriene
ACTIVE COMPARATORPlacebo + Calcipotriene
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Sienna 018
Anniston, Alabama, 36207, United States
Sienna 009
Mobile, Alabama, 36608, United States
Sienna 019
Fountain Valley, California, 92708, United States
Sienna 007
Los Angeles, California, 90045, United States
Site 016
Sherman Oaks, California, 91403, United States
Site 013
Coral Gables, Florida, 33143, United States
Site 015
Sanford, Florida, 32771, United States
Site 012
Indianapolis, Indiana, 46256, United States
Sienna 011
Warren, Michigan, 48088, United States
Sienna 005
Berlin, New Jersey, 08009, United States
Sienna 020
Rochester, New York, 14623, United States
Site 014
Raleigh, North Carolina, 27612, United States
Sienna 002
Oklahoma City, Oklahoma, 73118, United States
Sienna 017
Austin, Texas, 78745, United States
Sienna 010
Houston, Texas, 77004, United States
Sienna 021
Pflugerville, Texas, 78660, United States
Sienna 001
San Antonio, Texas, 78213, United States
Sienna 006
Surrey, British Columbia, V3R 6A7, Canada
Sienna 008
Peterborough, Ontario, K9J 5K2, Canada
Sienna 003
Montreal, Quebec, H2K 4L5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 27, 2018
Study Start
February 12, 2018
Primary Completion
November 21, 2018
Study Completion
December 10, 2018
Last Updated
February 8, 2019
Record last verified: 2019-02