A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 70
Updated:4/17/2018
Start Date:October 13, 2017
End Date:February 6, 2018

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A Phase 1b Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study Assessing the PK, Pharmacodynamics, Safety, and Tolerability of SB414 in Subjects With Psoriasis

The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety,
and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.

This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be
conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis.
After obtaining informed consent, subjects will be randomized to active or vehicle treatment
arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all
affected areas of psoriasis on the trunk and/or extremities for 4 weeks.

Inclusion Criteria:

- Be male or female, 18-70 years old, and in good general health;

- Have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate
severity based on the PSGA, involving 2-15% BSA (excluding the scalp/face), present
for > 6 months;

- Must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a
TPSS > 5 and thickness sub-score > 2. Target plaques cannot be located on the groin,
hands, feet, neck, face, elbows, knees, ankles or scalp;

- Be willing to not use any other systemic agents used to treat psoriasis or apply any
other topical products (medicated or over-the-counter) to the treatment sites on the
trunk and/or extremities during the study;

- Women of childbearing potential (WOCBP) must have a negative UPT prior to
randomization and must agree to use an effective method of birth control during the
study and for 30 days after their final study visit.

Exclusion Criteria:

- Have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis,
guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic
arthritis requiring treatment with disease modifying antirheumatic drugs (DMARDs);

- Concurrent or recent use of topical or systemic medications without a sufficient
washout period;

- Are immunocompromised, including those who are known HIV positive or received
immunosuppressive treatment within the past 6 months;

- Female subjects who are pregnant, nursing mothers, or planning to become pregnant
during the study.
We found this trial at
4
sites
Austin, Texas 78759
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Boise, Idaho 83704
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Boise, ID
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College Station, Texas 77845
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College Station, TX
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Norfolk, Virginia 23502
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Norfolk, VA
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