PsoriasisPhase 1NCT03445013
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
A Phase 1 study testing SB414 6% in people with Psoriasis, run by Novan, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- SB414 6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Oct 2017to 6 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Novella Site# 183
Austin, Texas, 78759
Novella Site# 247
Boise, Idaho, 83704
Novella Site# 249
College Station, Texas, 77845
Novella Site# 114
Norfolk, Virginia, 23502
About this study
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
The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB414 6%Drug
Also called NVN1000
Twice daily
VehicleDrug
Also called Placebo
Vehicle Comparator
| Study group | Role | What they receive |
|---|---|---|
| SB414 6% | Experimental | SB414 6% topically twice daily Receives: Drug: SB414 6% |
| Vehicle Cream | Placebo comparator | Vehicle Cream topically twice daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of hMAP3
Peak plasma concentrations of hMAP3 after topical application of SB414
Measured: Day 29
Secondary outcomes (6)
Safety Profile (Reported Adverse Events)
Reported Adverse Events
Measured: Day 29
Subject Assessment of Tolerability
Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging
Measured: Baseline, Week 2 and Week 4
Efficacy Assessed by Target Plaque Severity Score (TPSS)
Target Plaque Severity Score will be collected
Measured: Baseline, Week 2 and Week 4
Pharmacodynamics of SB414
Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)
Measured: Day 29
Efficacy Assessed by Physician's Static Global Assessment
Physician's Static Global Assessment based on overall evaluation of the disease severity
Measured: Screening, Baseline, Week 2 and Week 4
Efficacy as assessed by Itch Numeric Rating Scale (NRS)
Itching due to psoriasis as reported by subject on a 11-point rating scale
Measured: Screening, Baseline, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start13 Oct 2017
- Primary completion31 Jan 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Responsible party
- Sponsor
- Investigators
- Tomoko Maeda-Chubachi, MD, Study chair, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445013
- Sponsor's protocol ID
- NI-PS101
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03445013
- Acronym / sponsor ID
- NI-PS101
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB414 6% | Experimental | Drug: SB414 6%SB414 6% topically twice daily |
| Vehicle Cream | Placebo comparator | Drug: VehicleVehicle Cream topically twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB414 6%Also: NVN1000Twice daily | Drug | SB414 6% |
| VehicleAlso: PlaceboVehicle Comparator | Drug | Vehicle Cream |
Primary outcome
Plasma concentrations of hMAP3
Time frame: Day 29
Peak plasma concentrations of hMAP3 after topical application of SB414
6 secondary outcomes
Safety Profile (Reported Adverse Events)
Time frame: Day 29
Subject Assessment of Tolerability
Time frame: Baseline, Week 2 and Week 4
Efficacy Assessed by Target Plaque Severity Score (TPSS)
Time frame: Baseline, Week 2 and Week 4
Pharmacodynamics of SB414
Time frame: Day 29
Efficacy Assessed by Physician's Static Global Assessment
Time frame: Screening, Baseline, Week 2 and Week 4
Efficacy as assessed by Itch Numeric Rating Scale (NRS)
Time frame: Screening, Baseline, Week 2 and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoko Maeda-Chubachi, MD study chair
Novan, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB414 6% in people with Psoriasis, run by Novan, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of hMAP3 (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.