LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

NCT ID: NCT02888236

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study of LEO 32731 in the treatment of psoriasis vulgaris

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LEO 32731 tablet

LEO 32731 30 mg two times daily for 16 weeks

Group Type EXPERIMENTAL

LEO 32731

Intervention Type DRUG

LEO 32731 Placebo tablet

LEO 32731 placebo two times daily for 16 weeks

Group Type PLACEBO_COMPARATOR

LEO 32731 Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LEO 32731

Intervention Type DRUG

LEO 32731 Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandra Philipp, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité Universitätsmedizin Berlin, Dept. of Dermatology

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LP0058-1072

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical Aprepitant in Prurigo Patients
NCT01963793 COMPLETED PHASE2
STA-21 Topical Efficacy on Psoriasis
NCT01047943 COMPLETED PHASE1/PHASE2