LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

August 25, 2017 updated by: LEO Pharma
A study of LEO 32731 in the treatment of psoriasis vulgaris

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

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

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin, Dept. of Dermatology

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent
  • Aged between 18 years and 65.
  • Males or females of non-childbearing potential.
  • Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
  • Have moderate to severe psoriasis vulgaris
  • Candidates of systemic anti-psoriatic treatment and/or phototherapy

Exclusion Criteria:

  • Subjects with therapy resistant psoriasis
  • Previously exposed to apremilast
  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
  • Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris

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: LEO 32731 tablet
LEO 32731 30 mg two times daily for 16 weeks
Drug: LEO 32731
Placebo Comparator: LEO 32731 Placebo tablet
LEO 32731 placebo two times daily for 16 weeks
Drug: LEO 32731 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis Area and Severity Index (PASI) at week 16
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16
Time Frame: Week 16
Week 16
Itch evaluated by itch Numerical Rating Scale (NRS) at week 16
Time Frame: Week 16
Week 16

Collaborators and Investigators

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

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Sandra Philipp, PhD, Charite University, Berlin, Germany

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 (Actual)

September 1, 2016

Primary Completion (Actual)

June 20, 2017

Study Completion (Actual)

July 6, 2017

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0058-1072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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