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Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test

NCT ID: NCT04221906

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-03-06

Brief Summary

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This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle.

Detailed Description

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This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual comparison of all 6 treatments.

Conditions

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Chronic Plaque Psoriasis

Keywords

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BOS-475 antipsoriatic efficacy safety psoriasis plaque test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BOS-475 0.5%

Daily application of BOS-475 0.5%

Group Type EXPERIMENTAL

BOS-475

Intervention Type DRUG

topical cream

BOS-475 1%

Daily application of BOS-475 1%

Group Type EXPERIMENTAL

BOS-475

Intervention Type DRUG

topical cream

BOS-475 2%

Daily application of BOS-475 2%

Group Type EXPERIMENTAL

BOS-475

Intervention Type DRUG

topical cream

Active ingredient-free vehicle cream

Daily application of vehicle cream

Group Type PLACEBO_COMPARATOR

Active ingredient-free vehicle cream

Intervention Type DRUG

topical cream

Daivonex cream

Daily application of Daivonex cream (calcipotriol 0.005%)

Group Type ACTIVE_COMPARATOR

Daivonex cream (calcipotriol 0.005%)

Intervention Type DRUG

topical cream

Betnesol-V cream (betamethasone 0.1%)

Daily application of Betnesol-V cream (betamethasone 0.1%)

Group Type ACTIVE_COMPARATOR

Betnesol-V cream (betamethasone 0.1%)

Intervention Type DRUG

topical cream

Interventions

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BOS-475

topical cream

Intervention Type DRUG

Active ingredient-free vehicle cream

topical cream

Intervention Type DRUG

Daivonex cream (calcipotriol 0.005%)

topical cream

Intervention Type DRUG

Betnesol-V cream (betamethasone 0.1%)

topical cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men, or women of non-childbearing potential aged 18-69 years (inclusive)
* Participants with chronic stable plaque psoriasis
* The target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
* Willing and able to follow all trial procedures and complete the whole trial
* 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 on the target areas, other than those mandated by the protocol or for protocol procedures

Exclusion Criteria

* Other skin disease or infection that is considered by the investigator to be relevant to the outcome of the trial
* Participants with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica or pustular psoriasis
* Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar) in the 4 weeks before first treatment and/or during the trial (pretreatment with salicylic acid is permitted on selected plaques; treatment on the face, ears and scalp is also permitted as lesions are not involved in the trial)
* Systemic treatment with antipsoriatics, e.g., corticosteroids, cytostatics, retinoids, dimethylfumarate or apremilast in the three months before first treatment and during the trial
* Systemic treatment with biological treatments: ustekinumab or secukinumab within six months or adalimumab, infliximab, and etanercept within three months before first treatment and during the trial. Any other previously used biologics for treatment of psoriasis should have been washed out for five half lives before first treatment.
* Ultraviolet A (UVA) or B-therapy within four weeks and psoralen and ultraviolet A (PUVA)-therapy within eight weeks before first treatment and during the trial treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g., antimalarial drugs, lithium, beta-blockers, or angiotensin-converting-enzyme (ACE) inhibitors unless on a stable dose for 3 months before trial medication initiation
* History of malignancy within 5 years prior to dosing, except adequately treated non-invasive skin cancer (basal or squamous cell carcinoma
* Positive urine drug or breath 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 trial 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 milliliters \[mL\]) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits
* Blood pressure (BP) \>160 millimeters of mercury (mmHg) systolic or \>95 mmHg diastolic at screening
* Participation in another clinical trial within the last six months for biological agents, or four weeks for small molecules prior to first treatment in this clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaobing Qian, MD, PhD

Role: STUDY_DIRECTOR

Boston Pharmaceuticals, Vice President, Clinical Development

Locations

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Gemeinschaftspraxis Dr. med. Johannes Niesmann und Dr. med. Nick Othlinghaus Hauszentrum im Jahrhunderthaus - Zentrum für klinische Studien

Bochum, , Germany

Site Status

bioskin GmbH

Hamburg, , Germany

Site Status

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2019-002447-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BOS-475-102

Identifier Type: -

Identifier Source: org_study_id