LEO 32731 for the Treatment of Moderate to Severe Psorias... | NCT02888236

Studies
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

NCT02888236

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Aug 28, 2017Actual

Enrollment

36Actual

Phase

Phase 2

Conditions

Psoriasis Vulgaris

Interventions

LEO 32731
LEO 32731 Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Jun 20, 2017Actual

Completion Date

Jul 6, 2017Actual

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2017

Last Update Posted Date

Aug 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LEO 32731 tablet	Experimental	LEO 32731 30 mg two times daily for 16 weeks	Drug: LEO 32731
LEO 32731 Placebo tablet	Placebo Comparator	LEO 32731 placebo two times daily for 16 weeks	Drug: LEO 32731 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LEO 32731	Drug		LEO 32731 tablet
LEO 32731 Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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		Week 16
Itch evaluated by itch Numerical Rating Scale (NRS) at week 16		Week 16

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Philipp, PhD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitätsmedizin Berlin, Dept. of Dermatology		Berlin		10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided