NCT02888236

Brief Summary

A study of LEO 32731 in the treatment of psoriasis vulgaris

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 30, 2016

Last Update Submit

August 25, 2017

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Psoriasis Area and Severity Index (PASI) at week 16

    Week 16

Secondary Outcomes (2)

  • 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

Study Arms (2)

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

LEO 32731DRUG
LEO 32731 tablet
LEO 32731 PlaceboDRUG
LEO 32731 Placebo tablet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin, Dept. of Dermatology

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sandra Philipp, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 2, 2016

Study Start

September 1, 2016

Primary Completion

June 20, 2017

Study Completion

July 6, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

DE(1)