A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
Completed · Phase 1 · Has a placebo group
Conditions studied: Psoriasis
In brief
The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
Key facts
- Study ID
- NCT03445013
- Run by
- Novan, Inc.
- People needed
- 36
- Starts
- 2017-10-13
- Expected to finish
- 2018-02-06
- Last updated by the study team
- 2018-03-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novella Site# 247 — Boise, Idaho, United States
- Novella Site# 183 — Austin, Texas, United States
- Novella Site# 249 — College Station, Texas, United States
- Novella Site# 114 — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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