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LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LEO 32731
LEO 32731 Placebo
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin, Dept. of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LEO 32731 tablet

LEO 32731 Placebo tablet

Arm Description

LEO 32731 30 mg two times daily for 16 weeks

LEO 32731 placebo two times daily for 16 weeks

Outcomes

Primary Outcome Measures

Psoriasis Area and Severity Index (PASI) at week 16

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2016
Last Updated
August 25, 2017
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02888236
Brief Title
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Official Title
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study of LEO 32731 in the treatment of psoriasis vulgaris
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 32731 tablet
Arm Type
Experimental
Arm Description
LEO 32731 30 mg two times daily for 16 weeks
Arm Title
LEO 32731 Placebo tablet
Arm Type
Placebo Comparator
Arm Description
LEO 32731 placebo two times daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
LEO 32731
Intervention Type
Drug
Intervention Name(s)
LEO 32731 Placebo
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) at week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
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
Title
Itch evaluated by itch Numerical Rating Scale (NRS) at week 16
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Philipp, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin, Dept. of Dermatology
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

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