Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris

• Sponsor: Sienna Biopharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03322137
• Collaborator: (none)
• Enrollment: 208
• Locations: 38
• Arms: 3
• Actual Duration (Months): 12.4
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of SNA-120 (Pegcantratinib) Ointment in Subjects With Pruritus Associated With Psoriasis Vulgaris
• Actual Study Start Date: Oct 10, 2017
• Actual Primary Completion Date: Sep 10, 2018
• Actual Study Completion Date: Oct 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SNA-120 (0.05% ) Pegcantratinib Ointment	Drug: SNA-120; Pegcantratinib ointment
Active Comparator: SNA-120 (0.5%) Pegcantratinib Ointment	Drug: SNA-120; Pegcantratinib ointment
Placebo Comparator: Vehicle	Drug: Vehicle; Placebo ointment to mimic Pegcantratinib ointment

Outcome Measures

Primary Outcome Measures

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

   The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

2. Change in Itch Numeric Rating Scale scores (I-NRS) [week 2]

   The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

3. Change in Itch Numeric Rating Scale scores (I-NRS) [week 4]

   The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

4. Change in Itch Numeric Rating Scale scores (I-NRS) [week 6]

   The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

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

   The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching

Secondary Outcome Measures

1. Proportion of subjects (≥ 1 grade change) on IGA scale [week 12]

   Investigator Global Assessment

2. Proportion of subjects (≥ 2 grade change) on IGA scale [week 12]

   Investigator Global Assessment

3. Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories [baseline and week 12]

   Investigator Global Assessment

4. Change in PASI-50 [baseline and week 12]

   Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index

Other Outcome Measures

1. Safety measured by incidence and severity of adverse events [up to 12 weeks]

2. Safety measured by change in clinical laboratory results from baseline [up to 12 weeks]

   urinalysis lab assessments

3. Safety measured by change in clinical laboratory results from baseline [up to 12 weeks]

   biochemistry lab assessments

4. Safety measured by change in clinical laboratory results from baseline [up to 12 weeks]

   hematology lab assessments

5. Safety measured by change in blood pressure from baseline [up to 12 weeks]

   systolic/diastolic blood pressure (BP in mmHg)

6. Safety measured by change in pulse from baseline [up to 12 weeks]

   Pulse (beats per minute [bpm])

7. Safety measured by number of abnormal physical examination changes [baseline and week 12]

   Any abnormal physical examination changes from baseline and week 12

8. Safety measured by PR/PQ intervals measured by 12-lead ECG [week 2]

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

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

11. Safety measured by QRS duration measured by 12-lead ECG [week 2]

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

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

14. Safety measured by QT interval measure by 12-lead ECG [week 2]

15. Safety measured by QT interval measure by 12-lead ECG [week 8]

16. Safety measured by QT interval measure by 12-lead ECG [week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization

• Stable PV for at least 6 months prior to screening

• Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening

• Mild to moderate PV at screening and baseline

• Has a target plaque at baseline on the trunk and/or limbs

• Subject's plaques are amenable to treatment with a topical ointment medication

• Willing and able to comply with the study instructions and attend all scheduled study visits.

• Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation

• Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study

• Men who are sexually active and can father 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

• Positive hepatitis serology

• Thyroid abnormalities that may impact itching

• Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus

• Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis

• Active psoriasis or itch affecting the palmar/plantar regions

• Subjects with a clinical diagnosis of bacterial infection of the skin

• Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome

• Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study

• Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that 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 of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)

• Female who is pregnant or lactating, or is planning to become pregnant during the study

• Subjects participating in any previous SNA-120 (and/or CT327) clinical studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 025	Scottsdale	Arizona	United States	85255
2	Sienna 022	Fort Smith	Arkansas	United States	72916
3	Site 028	Fountain Valley	California	United States	92708
4	Sienna 009	Fremont	California	United States	94538
5	Sienna 008	San Diego	California	United States	92123
6	Sienna 020	Santa Monica	California	United States	90404
7	Sienna 015	Denver	Colorado	United States	80220
8	Sienna 005	Farmington	Connecticut	United States	06032
9	Site 030	Shelton	Connecticut	United States	06484
10	Site 026	Doral	Florida	United States	33122
11	Sienna 019	Largo	Florida	United States	33770
12	Sienna 017	North Miami Beach	Florida	United States	33162
13	Sienna 024	Ocala	Florida	United States	34471
14	Site 027	West Palm Beach	Florida	United States	33406
15	Site 029	Macon	Georgia	United States	31217
16	Sienna 010	New Albany	Indiana	United States	47150
17	Sienna 011	Plainfield	Indiana	United States	46168
18	Sienna 023	Louisville	Kentucky	United States	40202
19	Site 038	Metairie	Louisiana	United States	70006
20	Site 032	Rockville	Maryland	United States	20850
21	Site 039	Clarkston	Michigan	United States	48346
22	Sienna 002	Fridley	Minnesota	United States	55432
23	Sienna 001	Saint Louis	Missouri	United States	63117
24	Sienna 004	East Windsor	New Jersey	United States	08520
25	Sienna 013	Albuquerque	New Mexico	United States	87106
26	Site 037	Rochester	New York	United States	14623
27	Sienna 016	High Point	North Carolina	United States	27626
28	Sienna 006	Winston-Salem	North Carolina	United States	27104
29	Site 041	Norman	Oklahoma	United States	73071
30	Sienna 003	Portland	Oregon	United States	97223
31	Site 031	Pittsburgh	Pennsylvania	United States	15213
32	Site 035	Murfreesboro	Tennessee	United States	37130
33	Sienna 012	Austin	Texas	United States	78759
34	Sienna 021	Dallas	Texas	United States	75246
35	Sienna 018	Houston	Texas	United States	77030
36	Site 034	Pflugerville	Texas	United States	78660
37	Sienna 007	Murray	Utah	United States	84107
38	Sienna 014	Norfolk	Virginia	United States	23502

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: NCT03322137
• Other Study ID Numbers: SNA-120-201
• First Posted: Oct 26, 2017
• 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
• Additional relevant MeSH terms: Psoriasis; Pruritus

Study Results

No Results Posted as of Feb 8, 2019