Trial record 1 of 1 for:
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
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| ClinicalTrials.gov Identifier: NCT03322137 |
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Recruitment Status :
Completed
First Posted : October 26, 2017
Last Update Posted : February 8, 2019
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Sponsor:
Sienna Biopharmaceuticals
Information provided by (Responsible Party):
Sienna Labs ( Sienna Biopharmaceuticals )
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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 Type : | Interventional (Clinical Trial) |
| 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 : | October 10, 2017 |
| Actual Primary Completion Date : | September 10, 2018 |
| Actual Study Completion Date : | October 22, 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: SNA-120 (0.05% )
Pegcantratinib Ointment
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Drug: SNA-120
Pegcantratinib ointment |
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Active Comparator: SNA-120 (0.5%)
Pegcantratinib Ointment
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Drug: SNA-120
Pegcantratinib ointment |
| Placebo Comparator: Vehicle |
Drug: Vehicle
Placebo ointment to mimic Pegcantratinib ointment |
Primary Outcome Measures :
- Change in Itch Numeric Rating Scale scores (I-NRS) [ Time Frame: week 1 ]The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
- Change in Itch Numeric Rating Scale scores (I-NRS) [ Time Frame: week 2 ]The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
- Change in Itch Numeric Rating Scale scores (I-NRS) [ Time Frame: week 4 ]The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
- Change in Itch Numeric Rating Scale scores (I-NRS) [ Time Frame: week 6 ]The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
- Change in Itch Numeric Rating Scale scores (I-NRS) [ Time Frame: week 8 ]The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Secondary Outcome Measures :
- Proportion of subjects (≥ 1 grade change) on IGA scale [ Time Frame: week 12 ]Investigator Global Assessment
- Proportion of subjects (≥ 2 grade change) on IGA scale [ Time Frame: week 12 ]Investigator Global Assessment
- Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories [ Time Frame: baseline and week 12 ]Investigator Global Assessment
- Change in PASI-50 [ Time Frame: baseline and week 12 ]Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index
Other Outcome Measures:
- Safety measured by incidence and severity of adverse events [ Time Frame: up to 12 weeks ]
- Safety measured by change in clinical laboratory results from baseline [ Time Frame: up to 12 weeks ]urinalysis lab assessments
- Safety measured by change in clinical laboratory results from baseline [ Time Frame: up to 12 weeks ]biochemistry lab assessments
- Safety measured by change in clinical laboratory results from baseline [ Time Frame: up to 12 weeks ]hematology lab assessments
- Safety measured by change in blood pressure from baseline [ Time Frame: up to 12 weeks ]systolic/diastolic blood pressure (BP in mmHg)
- Safety measured by change in pulse from baseline [ Time Frame: up to 12 weeks ]Pulse (beats per minute [bpm])
- Safety measured by number of abnormal physical examination changes [ Time Frame: baseline and week 12 ]Any abnormal physical examination changes from baseline and week 12
- Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 2 ]
- Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 8 ]
- Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 12 ]
- Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 2 ]
- Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 8 ]
- Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 12 ]
- Safety measured by QT interval measure by 12-lead ECG [ Time Frame: week 2 ]
- Safety measured by QT interval measure by 12-lead ECG [ Time Frame: week 8 ]
- Safety measured by QT interval measure by 12-lead ECG [ Time Frame: week 12 ]
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322137
Locations
Show 38 study locations
Sponsors and Collaborators
Sienna Biopharmaceuticals
| Responsible Party: | Sienna Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03322137 |
| Other Study ID Numbers: |
SNA-120-201 |
| First Posted: | October 26, 2017 Key Record Dates |
| Last Update Posted: | February 8, 2019 |
| Last Verified: | February 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Psoriasis Pruritus Skin Diseases, Papulosquamous Skin Diseases Skin Manifestations |