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

A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test

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

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: BOS-475; Drug: Active ingredient-free vehicle cream; Drug: Daivonex cream (calcipotriol 0.005%); Drug: Betnesol-V cream (betamethasone 0.1%)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany
    • Gemeinschaftspraxis Dr. med. Johannes Niesmann und Dr. med. Nick Othlinghaus Hauszentrum im Jahrhunderthaus - Zentrum für klinische Studien
  • Hamburg, Germany
    • Bioskin GmbH
  • Schwerin, Germany
    • Klinische Forschung Schwerin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOS-475 0.5%; Daily application of BOS-475 0.5%	Drug: BOS-475; topical cream
Experimental: BOS-475 1%; Daily application of BOS-475 1%	Drug: BOS-475; topical cream
Experimental: BOS-475 2%; Daily application of BOS-475 2%	Drug: BOS-475; topical cream
Placebo Comparator: Active ingredient-free vehicle cream; Daily application of vehicle cream	Drug: Active ingredient-free vehicle cream; topical cream
Active Comparator: Daivonex cream; Daily application of Daivonex cream (calcipotriol 0.005%)	Drug: Daivonex cream (calcipotriol 0.005%); topical cream
Active Comparator: Betnesol-V cream (betamethasone 0.1%); Daily application of Betnesol-V cream (betamethasone 0.1%)	Drug: Betnesol-V cream (betamethasone 0.1%); topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	-1 = worsened; 0 = unchanged (no effect); 1 = slight improvement; 2 = clear improvement but not completely healed; 3 = completely healed.	Baseline; Days 1, 8, 15, and 19 (End of Trial)

Collaborators and Investigators

• Sponsor: Boston Pharmaceuticals
• Investigators: Study Director: Xiaobing Qian, MD, PhD, Boston Pharmaceuticals, Vice President, Clinical Development

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: safety; BOS-475; antipsoriatic efficacy; psoriasis plaque test
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: BOS-475-102; 2019-002447-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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