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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03960450




Registration number
NCT03960450
Ethics application status
Date submitted
21/05/2019
Date registered
23/05/2019
Date last updated
18/11/2020

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis
Scientific title
A Phase I, Randomized, Vehicle-Controlled, Double-Blind (Sponsor Open) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis
Secondary ID [1] 0 0
BOS-475-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BOS-475
Treatment: Drugs - Vehicle

Experimental: Part A: BOS-475 - Daily application of BOS-475 0.5%, 1%, or 2%

Placebo Comparator: Part A: Vehicle cream - Daily application of vehicle cream

Experimental: Part B: BOS-475 - Daily application of BOS-475 0.5%, 1%, or 2%

Placebo Comparator: Part B: Vehicle cream - Daily application of vehicle cream


Treatment: Drugs: BOS-475
topical cream

Treatment: Drugs: Vehicle
topical cream
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parts A and B: Number of participants with any adverse event (AEs) and any serious adverse event (SAE)
Timepoint [1] 0 0
up to Week 8
Primary outcome [2] 0 0
Parts A and B: Change from baseline in the application site tolerability assessment score
Timepoint [2] 0 0
up to Week 8
Primary outcome [3] 0 0
Parts A and B: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values
Timepoint [3] 0 0
up to Week 8
Primary outcome [4] 0 0
Parts A and B: Number of participants with any clinically significant change from baseline in vital sign values
Timepoint [4] 0 0
up to Week 8
Primary outcome [5] 0 0
Parts A and B: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings
Timepoint [5] 0 0
up to Week 8
Secondary outcome [1] 0 0
Part A: Plasma concentration of BOS-475
Timepoint [1] 0 0
Day 1, predose and 1, 2, 4, 8, 24, 48, and 72 hours postdose; Days 5, 8, 9, and 10, predose; Day 11, predose and 1, 2, 4, 8, and 24 hours postdose; Days 15 to 17, predose; Day 18, predose and 1, 2, 4, 8, and 24 hours postdose
Secondary outcome [2] 0 0
Part B: Plasma concentration of BOS-475
Timepoint [2] 0 0
Days 1, 2, 8, 21, 28, and 35: predose. Day 14: predose; 1 (±15 minutes [min]), 2 (±15 min), 4 (±30 min), and 8 (±2 hours [hr]) hr postdose. Day 15: predose (24 hr [±2 hr] postdose from previous dose on Day 14); at time of study visits on Days 43 and 56

Eligibility
Key inclusion criteria
Part A

- Healthy male or female participants 18 to 65 years of age inclusive, at the time of
signing the informed consent.

- Male participants must agree to use contraception as detailed in the protocol
during the treatment period and for at least 90 days (a spermatogenesis cycle)
after the last dose of study drug and refrain from donating sperm during this
period.

o Male participants who have had a vasectomy with documentation of azoospermia
are not required to use contraception.

- Female participants must be of non-child bearing potential, defined as 1) at
least 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH)
> 40 milliInternational Units per milliliter (mIU/ml), or 2) having a documented
tubal ligation at least 6 weeks prior to dosing; or 3) having had a surgical
bilateral oophorectomy (with or without hysterectomy).

- Participants who are healthy as determined by the Investigator or medically qualified
designee based on a medical evaluation including medical history, physical
examination, laboratory tests, and cardiac monitoring.

- Participants with body mass index (BMI) within the range 18 to 30 kilograms per meters
squared (kg/m^2) (inclusive).

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the Informed Consent Form (ICF) and in this
protocol

- Willing to refrain from using any topical treatments, other than those mandated by the
protocol or for protocol procedures

Part B

- Male or female participants with mild to moderate psoriasis 18 to 65 years of age
inclusive, at the time of signing the informed consent

- Male participant must agree to use contraception as detailed in the protocol
during the treatment period and for at least 90 days (a spermatogenesis cycle)
after the last dose of study drug and refrain from donating sperm during this
period.

o Male participants who have had a vasectomy with documentation of azoospermia
are not required to use contraception.

- Female of non-child bearing potential is defined as 1) at least 12 months of
spontaneous amenorrhea with FSH > 40 mIU/mL, or 2) having a documented tubal
ligation at least 6 weeks prior to dosing; or 3) having had a surgical bilateral
oophorectomy (with or without hysterectomy).

- Participants who have a clinical diagnosis of stable plaque psoriasis for = 6 months,
as confirmed by the Investigator

- A Psoriasis Physician Global Assessment (PGA) score of = 2 at screening and Day 1

- At least 1 psoriasis plaque located on the trunk or extremities (excluding knees and
elbows) that is at least 5 centimeters squared (cm^2) in size at Screening and Day 1
with a Target Plaque Severity Score (TPSS) = 5 and induration subscore = 2

- Body Surface Area (BSA) involvement of psoriasis lesions between 2% and 15%, excluding
face, scalp, palms, soles, nails, and intertriginous areas at screening

- Participants with BMI within the range 18 to 35 kg/m^2 (inclusive)

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the ICF and in this protocol

- Willing to refrain from using any topical treatments, other than those mandated by the
protocol or for protocol procedures
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, hematological, neurological, or skin disorders, in the Investigator's
opinion, may significantly alter the absorption, metabolism, or elimination of drugs;
constituting a risk when taking the study treatment; or interfering with the
interpretation of data

- Current evidence of any acute cutaneous infection, history of repeated or chronic
significant skin infections (unless irrelevant in the opinion of the Investigator,
i.e., onychomycosis, labial herpes or other minor diagnosis)

- Women of child-bearing potential, is pregnant, or is breastfeeding

- Known history of chronic hepatitis or human immunodeficiency virus (HIV); positive
findings of hepatitis B surface antigen or hepatitis C virus (HCV) antibody associated
with a positive HCV ribonucleic acid (RNA) polymerase chain reaction; or positive HIV
screening test suggesting active disease at the screening visit

- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)

- Abnormal blood pressure, liver, or renal function

- History of malignancy within 5 years prior to dosing, except adequately treated
non-invasive skin cancer (basal or squamous cell carcinoma)

- History of hypersensitivity to any of the study treatments, or components thereof, or
drug or other allergy that, in the opinion of the Investigator or medical monitor,
contraindicates participation in the study

- For Part A only: psoriasis of any kind (i.e., plaque, acute psoriasis guttate,
psoriasis punctata, psoriasis erythroderma, or pustular psoriasis)

- For Part A only: any clinically-relevant skin disease or other skin pathologies, that
may, in the opinion of the Investigator, contraindicate participation or interfere
with skin evaluations

- For Part A only: history or risk of complications from skin biopsy including impaired
wound healing, excess bleeding, infection, or scarring/keloid formation or known
hypersensitivity to local anesthetics. Use of anticoagulant medication.

- Use of prohibited concomitant medications or natural products within the defined
periods before the Day 1 visit and during the trial

- Current heavy smoker (those who smoke = 25 cigarettes a day) or former heavy smoker
who has stopped smoking within 1 month prior to screening

- Positive urine drug or alcohol test results during screening, or at Day 1, or history
of drug abuse within a year prior to the screening visit

- Excess alcohol consumption within 6 months prior to the study defined as an average
weekly intake of > 14 units for males and females. One unit is equivalent to 8 grams
of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL)
measure of spirits

- Donation or significant loss of blood within 3 months prior to screening, or plasma up
to 14 days prior to screening

- Participation in any clinical research study within 30 days or 5 half-lives, of the
investigational product, whichever is greater, prior to the screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/01/2020
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [2] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [3] 0 0
Linear - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study was conducted to evaluate the safety and tolerability of BOS-475 following single
and repeat topical administration to healthy participants (Part A), and to evaluate the
safety and tolerability of 42-day repeat topical administration of BOS-475 to participants
with plaque psoriasis (Part B).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03960450
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Xiaobing Qian, MD, PhD
Address 0 0
Boston Pharmaceuticals, Vice President, Clinical Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03960450