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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis

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ClinicalTrials.gov Identifier: NCT03960450
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Pharmaceuticals

Brief Summary:
This study is being 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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BOS-475 Drug: Vehicle Phase 1

Detailed Description:

In Part A, healthy participants will be randomized to receive a single dose application of BOS-475 or vehicle cream. Following a washout period, participants will receive 7 days of repeated dosing with BOS-475 or vehicle cream on the back, followed by 7 days of repeated dosing of BOS-475 or vehicle cream over the facial area (excluding eye lids and areas around the mouth).

In Part B, participants with mild to moderate stable plaque psoriasis affecting up to 15% of their body surface area will be randomized to receive 6 weeks of topical treatment of BOS-475 or vehicle cream.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Part A: BOS-475
Daily application of BOS-475 0.5%, 1%, or 2%
Drug: BOS-475
topical cream

Placebo Comparator: Part A: Vehicle cream
Daily application of vehicle cream
Drug: Vehicle
topical cream

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

Placebo Comparator: Part B: Vehicle cream
Daily application of vehicle cream
Drug: Vehicle
topical cream




Primary Outcome Measures :
  1. Parts A and B: Number of participants with any adverse event (AEs) and any serious adverse event (SAE) [ Time Frame: up to Week 8 ]
  2. Parts A and B: Change from baseline in the application site tolerability assessment score [ Time Frame: up to Week 8 ]
    Change from baseline in the application site tolerability assessment score was measured using the Topical Application Site Tolerability Assessment Scale (5-point scale ranging from 0-no irritation to 4-very severe irritation).

  3. Parts A and B: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values [ Time Frame: up to Week 8 ]
  4. Parts A and B: Number of participants with any clinically significant change from baseline in vital sign values [ Time Frame: up to Week 8 ]
  5. Parts A and B: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings [ Time Frame: up to Week 8 ]

Secondary Outcome Measures :
  1. Part A: Plasma concentration of BOS-475 [ Time Frame: 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 ]
  2. Part B: Plasma concentration of BOS-475 [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03960450


Contacts
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Contact: Nicole Handley, Novotech 61 3 9341 1960 nicole.handley@novotech-cro.com

Locations
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Australia
CMAX Clinical Research Recruiting
Adelaide, Australia
Linear Recruiting
Nedlands, Australia
Sponsors and Collaborators
Boston Pharmaceuticals
Investigators
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Study Director: Xiaobing Qian, MD, PhD Boston Pharmaceuticals, Vice President, Clinical Development

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Responsible Party: Boston Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03960450     History of Changes
Other Study ID Numbers: BOS-475-101
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Pharmaceuticals:
Psoriasis
BOS-475
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases