Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test

February 11, 2019 updated by: DFB Soria, LLC

A Phase 1 Randomized, Placebo and Active Comparator-controlled Trial, Double-blind for the IPs, Observer-blind for the Active Comparator, to Assess the Potency of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment in a Psoriasis Plaque Test

Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two-center, randomized, placebo- and active comparator-controlled trial that will be double-blind for the investigational products (IPs) and observer-blind for the active comparator with intra-individual comparison of treatments. Twelve male and post-menopausal female volunteer subjects, aged 18 years or older, with psoriasis vulgaris and mild or moderate chronic plaque(s) in a stable phase and an area sufficient for six treatment fields, will be enrolled. SOR007 Ointment will be administered topically at four concentrations (0.15%, 0.3%, 1%, and 2%), in addition to a placebo ointment (SOR007 without the active pharmaceutical ingredient) and an active comparator, Taclonex® Ointment (calcipotriene 0.005 % and betamethasone dipropionate 0.064 %). Treatments will be administered once daily, 10 times over a 12-day trial period. Assessments will include safety, pharmacokinetics (PK), and preliminary efficacy as determined by measurement of psoriatic infiltrate using 22-megahertz (MHz) sonography as well as clinical scoring on a 5-point scale. Subjects who withdraw early for reasons unrelated to investigational product adverse events (AEs) will be replaced.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and surgically sterile or post-menopausal (at least since 12 months amenorrhoea) women aged 18 years or older. The non-childbearing potential of women needs to be confirmed by medical record or in writing by a gynecologist, if that is not possible a follicle stimulating hormone (FSH) test will be performed on female subjects to confirm menopause, unless they are receiving hormonal replacement therapy for treatment of menopause symptoms;
  • subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to three plaque areas sufficient for six treatment fields;
  • the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows are not to be used as a target lesion;
  • plaques to be treated should have a comparable psoriatic infiltrate thickness of at least 200 μm;
  • the physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
  • male volunteers must agree to sexual abstinence or use adequate contraception when sexually active in combination with their female partners, if they are of childbearing potential. That means the volunteer must be vasectomized or use a condom and his female partner must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, or non-DalKon Shield intra-uterine devices [IUDs]. This applies from signing of the informed consent form until 90 days after the last study drug administration. Methods of contraception must have been effective for at least 30 days on the day of signing the informed consent form. Male volunteers must also refrain from sperm donation from signing of the informed consent form until 90 days after the last study drug administration;
  • written informed consent obtained.

Exclusion Criteria:

  • pregnancy and nursing;
  • other skin disease or condition noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial;
  • subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica and pustular psoriasis;
  • any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before first treatment and/or during the trial;
  • systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate 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;
  • UV-therapy within four weeks before first treatment and during the trial;
  • treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium) within eight weeks before first treatment and/or during the trial. Beta-blockers or angiotensin-converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before study medication initiation;
  • intake of Anticoagulant Drugs, e.g. Warfarin, Coumadin. Antiplatelet Drugs e.g. Acetyl salicylic acid are permitted unless considered contraindicated by the investigator for blood withdrawal for PK analyses;
  • known allergic reactions, irritations or sensitivity to the active ingredients or other components of the IPs;
  • known allergic reactions, irritations or sensitivity to the comparator's active ingredient and/or components;
  • contraindications according to summary of product characteristics of the active comparator;
  • evidence of drug or alcohol abuse;
  • symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
  • participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial;
  • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
  • close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or Modoc or subject is an employee of sponsor;
  • subject is institutionalized because of legal or regulatory order.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOR007 Ointment 2.0%
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: SOR007 Ointment 2.0%
Experimental: SOR007 Ointment 1.0%
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: SOR007 Ointment 1.0%
Experimental: SOR007 Ointment 0.3%
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: SOR007 Ointment 0.3%
Experimental: SOR007 Ointment 0.15%
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: SOR007 Ointment 0.15%
Placebo Comparator: SOR007 Ointment Placebo
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: SOR007 Ointment Placebo
Active Comparator: Taclonex® Ointment
Topical application once daily during a 12-day treatment period (10 treatments)
Drug: Taclonex® Ointment
Other Names:
  • calcipotriene 0.005%/betamethasone dipropionate 0.064%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the thickness of the echolucent band (ELB)
Time Frame: 12 days
12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score
Time Frame: 12 days
12 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety analysis: Summary of Treatment-Emergent Adverse Events
Time Frame: 26 days
Treatment-emergent adverse events (TEAEs), i.e. AEs with an onset or worsening on or after the time of the first investigational product (IP) application, will be reported. TEAEs will be summarized by the number of subjects reporting TEAEs, primary system organ class (SOC), preferred term (PT), severity, and relationship to IP. Summaries will be provided by the relation to a specific treatment test field or as not related to a specific test field. Vital signs parameters will be summarized descriptively by treatment and visit, including changes from screening visit. Only clinical relevance will be listed.
26 days
Pharmacokinetic analysis: Maximum Plasma Concentration of Paclitaxel (Cmax)
Time Frame: 12 days
PK levels of paclitaxel in the plasma will be summarized descriptively.
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DFB Soria, LLC

Collaborators

Bioskin GmbH
US Biotest, Inc.

Investigators

  • Study Chair: Gere S diZerega, MD, US Biotest, Inc./DFB Soria, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

February 13, 2017

Study Completion (Actual)

February 13, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR007-2016-01

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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