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LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02888236
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 32731 Drug: LEO 32731 Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) at week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Itch evaluated by itch Numerical Rating Scale (NRS) at week 16 [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888236


Locations
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Germany
Charité Universitätsmedizin Berlin, Dept. of Dermatology
Berlin, Germany, 10117
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Sandra Philipp, PhD Charite University, Berlin, Germany

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02888236     History of Changes
Other Study ID Numbers: LP0058-1072
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by LEO Pharma:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases