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

• Sponsor: Sienna Biopharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03448081
• Collaborator: (none)
• Enrollment: 73
• Locations: 20
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus; Psoriasis	Drug: SNA-120; Drug: Placebo; Drug: Calcipotriene	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 12, 2018
• Actual Primary Completion Date: Nov 21, 2018
• Actual Study Completion Date: Dec 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
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: Placebo; Vehicle Ointment; Drug: Calcipotriene; Calcipotriene ointment (0.005%)

Outcome Measures

Primary Outcome Measures

1. Change in Itch Numeric Rating Scale scores (I-NRS) from baseline [week 8]

   11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)

Secondary Outcome Measures

1. Change in Investigator Global Assessment (IGA) from baseline [week 8]

   5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)

2. Change in Psoriasis Area Severity Index (PASI) from baseline [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)

Other Outcome Measures

1. Safety measured by frequency of Adverse Events [week 10]

   Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10

2. Safety measured by severity of Adverse Events [week 10]

   Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10

3. Safety measured by change in clinical lab results from baseline [week 10]

   biochemistry lab assessments

4. Safety measured by change in clinical lab results from baseline [week 10]

   Clinical laboratory assessments include urinalysis (pH, glucose, protein)

5. Safety measured by change in clinical lab results from baseline [week 10]

   hematology lab assessments

6. Safety measured by change from baseline in blood pressure [week 10]

   Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10

7. Safety measured by change from baseline in pulse [week 10]

   Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10

8. Safety measured by number of abnormal physical examinations from baseline [week 8]

9. Safety measured by PR/PQ intervals measured by 12-lead ECG [week -4]

   Safety measured by PR/PQ intervals measured by 12-lead ECG at screening

10. Safety measured by PR/PQ intervals measured by 12-lead ECG [week 0]

    Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline

11. Safety measured by PR/PQ intervals measured by 12-lead ECG [week 4]

    Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4

12. Safety measured by PR/PQ intervals measured by 12-lead ECG [week 8]

    Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8

13. Safety measured by QRS duration measured by 12-lead ECG [week -4]

    Safety measured by QRS duration measured by 12-lead ECG at screening

14. Safety measured by QRS duration measured by 12-lead ECG [week 0]

    Safety measured by QRS duration measured by 12-lead ECG at baseline

15. Safety measured by QRS duration measured by 12-lead ECG [week 4]

    Safety measured by QRS duration measured by 12-lead ECG at week 4

16. Safety measured by QRS duration measured by 12-lead ECG [week 8]

    Safety measured by QRS duration measured by 12-lead ECG at week 8

17. Safety measured by QT intervals measured by 12-lead ECG [week -4]

    Safety measured by QT intervals measured by 12-lead ECG at screening

18. Safety measured by QT intervals measured by 12-lead ECG [week 0]

    Safety measured by QT intervals measured by 12-lead ECG at baseline

19. Safety measured by QT intervals measured by 12-lead ECG [week 4]

    Safety measured by QT intervals measured by 12-lead ECG at week 4

20. Safety measured by QT intervals measured by 12-lead ECG [week 8]

    Safety measured by QT intervals measured by 12-lead ECG at week 8

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Sienna Biopharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sienna Biopharmaceuticals
• ClinicalTrials.gov Identifier: NCT03448081
• Other Study ID Numbers: SNA-120-202
• First Posted: Feb 27, 2018
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• 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
• Additional relevant MeSH terms: Psoriasis; Pruritus; Calcipotriene

Study Results

No Results Posted as of Feb 8, 2019