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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448081
• Other study ID #: SNA-120-202
• Status: Completed
• Phase: Phase 2
• Start date: February 12, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: February 2019
• Source: Sienna Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 10, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Psoriasis

Intervention

Drug:
• SNA-120
SNA-120 (0.5%) active ointment
• Placebo
Vehicle Ointment
• Calcipotriene
Calcipotriene ointment (0.005%)

Locations

Country	Name	City	State
Canada	Sienna 003	Montreal	Quebec
Canada	Sienna 008	Peterborough	Ontario
Canada	Sienna 006	Surrey	British Columbia
United States	Sienna 018	Anniston	Alabama
United States	Sienna 017	Austin	Texas
United States	Sienna 005	Berlin	New Jersey
United States	Site 013	Coral Gables	Florida
United States	Sienna 019	Fountain Valley	California
United States	Sienna 010	Houston	Texas
United States	Site 012	Indianapolis	Indiana
United States	Sienna 007	Los Angeles	California
United States	Sienna 009	Mobile	Alabama
United States	Sienna 002	Oklahoma City	Oklahoma
United States	Sienna 021	Pflugerville	Texas
United States	Site 014	Raleigh	North Carolina
United States	Sienna 020	Rochester	New York
United States	Sienna 001	San Antonio	Texas
United States	Site 015	Sanford	Florida
United States	Site 016	Sherman Oaks	California
United States	Sienna 011	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sienna Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety measured by frequency of Adverse Events	Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10	week 10
Other	Safety measured by severity of Adverse Events	Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10	week 10
Other	Safety measured by change in clinical lab results from baseline	biochemistry lab assessments	week 10
Other	Safety measured by change in clinical lab results from baseline	Clinical laboratory assessments include urinalysis (pH, glucose, protein)	week 10
Other	Safety measured by change in clinical lab results from baseline	hematology lab assessments	week 10
Other	Safety measured by change from baseline in blood pressure	Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10	week 10
Other	Safety measured by change from baseline in pulse	Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10	week 10
Other	Safety measured by number of abnormal physical examinations from baseline		week 8
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at screening	week -4
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline	week 0
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4	week 4
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8	week 8
Other	Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at screening	week -4
Other	Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at baseline	week 0
Other	Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at week 4	week 4
Other	Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at week 8	week 8
Other	Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at screening	week -4
Other	Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at baseline	week 0
Other	Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at week 4	week 4
Other	Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at week 8	week 8
Primary	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	Change in Investigator Global Assessment (IGA) from baseline	5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)	week 8
Secondary	Change in Psoriasis Area Severity Index (PASI) from baseline	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