Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Status: | Completed |
---|---|
Conditions: | Allergy, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Otolaryngology |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 2/10/2019 |
Start Date: | October 10, 2017 |
End Date: | October 22, 2018 |
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
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.
when administered topically for the treatment of pruritus associated with psoriasis vulgaris
(PV) and PV itself.
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
We found this trial at
38
sites
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