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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03445013
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : March 27, 2018
Novella Clinical
Information provided by (Responsible Party):
Novan, Inc.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: SB414 6% Drug: Vehicle Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study Assessing the PK, Pharmacodynamics, Safety, and Tolerability of SB414 in Subjects With Psoriasis
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: SB414 6%
SB414 6% topically twice daily
Drug: SB414 6%
Twice daily
Other Name: NVN1000

Placebo Comparator: Vehicle Cream
Vehicle Cream topically twice daily
Drug: Vehicle
Vehicle Comparator
Other Name: Placebo

Primary Outcome Measures :
  1. Plasma concentrations of hMAP3 [ Time Frame: Day 29 ]
    Peak plasma concentrations of hMAP3 after topical application of SB414

Secondary Outcome Measures :
  1. Safety Profile (Reported Adverse Events) [ Time Frame: Day 29 ]
    Reported Adverse Events

  2. Subject Assessment of Tolerability [ Time Frame: Baseline, Week 2 and Week 4 ]
    Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging

  3. Efficacy Assessed by Target Plaque Severity Score (TPSS) [ Time Frame: Baseline, Week 2 and Week 4 ]
    Target Plaque Severity Score will be collected

  4. Pharmacodynamics of SB414 [ Time Frame: Day 29 ]
    Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)

  5. Efficacy Assessed by Physician's Static Global Assessment [ Time Frame: Screening, Baseline, Week 2 and Week 4 ]
    Physician's Static Global Assessment based on overall evaluation of the disease severity

  6. Efficacy as assessed by Itch Numeric Rating Scale (NRS) [ Time Frame: Screening, Baseline, Week 2 and Week 4 ]
    Itching due to psoriasis as reported by subject on a 11-point rating scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT03445013

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United States, Idaho
Novella Site# 247
Boise, Idaho, United States, 83704
United States, Texas
Novella Site# 183
Austin, Texas, United States, 78759
Novella Site# 249
College Station, Texas, United States, 77845
United States, Virginia
Novella Site# 114
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Novan, Inc.
Novella Clinical
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Study Chair: Tomoko Maeda-Chubachi, MD Novan, Inc.

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Responsible Party: Novan, Inc. Identifier: NCT03445013     History of Changes
Other Study ID Numbers: NI-PS101
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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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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Skin Diseases, Papulosquamous
Skin Diseases