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

NCT04221906 | Completed Phase 1 FDA Drug

• 2 other identifiers: BOS-475-1022019-002447-17
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Plaque Psoriasis

Keywords

BOS-475; antipsoriatic efficacy; safety; psoriasis plaque test

Outcome Measures

Primary Outcomes (7)

• Number of treatment-emergent adverse events (TEAEs)

  up to Day 19

• Number of treatment-emergent application site reactions

  up to Day 19

• Change from Baseline in systolic and diastolic blood pressure

  Baseline; up to Day 19

• Change from Baseline in pulse

  Baseline; up to Day 19

• Change from Baseline in respiration

  Baseline; up to Day 19

• Change from Baseline in body temperature

  Baseline; up to Day 19

• Number of participants with clinically significant physical examination findings

  up to Day 19

Secondary Outcomes (4)

• Change from Baseline in psoriatic infiltrate thickness on Day 19 (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-megahertz (MHz) sonography)

  Baseline; Day 19

• Change from Baseline in psoriatic infiltrate thickness on Days 8 and 15 (assessed by measurement of the thickness of the EPB of the inflammatory infiltrate using 22-MHz sonography)

  Baseline; Days 8 and 15

• Area under the curve (AUC) of change from Baseline in thickness of the EPB of the inflammatory infiltrate

  Baseline; Day 19

• Change from Baseline in the test fields compared to the surrounding plaque skin, as an evaluation of the antipsoriatic efficacy by clinical assessment, using a 5-point score

  Baseline; Days 1, 8, 15, and 19 (End of Trial)

Study Arms (6)

BOS-475 0.5%

EXPERIMENTAL

Daily application of BOS-475 0.5%

Drug: BOS-475

BOS-475 1%

EXPERIMENTAL

Daily application of BOS-475 1%

Drug: BOS-475

BOS-475 2%

EXPERIMENTAL

Daily application of BOS-475 2%

Drug: BOS-475

Active ingredient-free vehicle cream

PLACEBO COMPARATOR

Daily application of vehicle cream

Drug: Active ingredient-free vehicle cream

Daivonex cream

ACTIVE COMPARATOR

Daily application of Daivonex cream (calcipotriol 0.005%)

Drug: Daivonex cream (calcipotriol 0.005%)

Betnesol-V cream (betamethasone 0.1%)

ACTIVE COMPARATOR

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

Drug: Betnesol-V cream (betamethasone 0.1%)

Interventions

BOS-475 DRUG

topical cream

BOS-475 0.5%; BOS-475 1%; BOS-475 2%

Active ingredient-free vehicle cream DRUG

topical cream

Active ingredient-free vehicle cream

Daivonex cream (calcipotriol 0.005%) DRUG

topical cream

Daivonex cream

Betnesol-V cream (betamethasone 0.1%) DRUG

topical cream

Betnesol-V cream (betamethasone 0.1%)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Pharmaceuticals: lead

Study Sites (3)

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

Bochum, Germany

Location

bioskin GmbH

Hamburg, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Germany

Location

Study Officials

• Xiaobing Qian, MD, PhD

  Boston Pharmaceuticals, Vice President, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 9, 2020
• Study Start: January 6, 2020
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)