Status:
COMPLETED
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
Lead Sponsor:
Novan, Inc.
Collaborating Sponsors:
Novella Clinical
Conditions:
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03445013
Start Date
October 13 2017
End Date
February 6 2018
Last Update
March 27 2018
Active Locations (4)
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1
Novella Site# 247
Boise, Idaho, United States, 83704
2
Novella Site# 183
Austin, Texas, United States, 78759
3
Novella Site# 249
College Station, Texas, United States, 77845
4
Novella Site# 114
Norfolk, Virginia, United States, 23502