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A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173301
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.

Brief Summary:

The purpose of the study are:

  1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of moderate-to-severe chronic plaque-type psoriasis.
  2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.
  3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: XP23829 400 mg QD Drug: XP 23829 800 mg QD Drug: XP23829 400 mg BID Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dose Levels of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
Study Start Date : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: XP23829 400 mg QD (once daily)
After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period
Drug: XP23829 400 mg QD
active dose 1

Experimental: XP23829 800 mg QD
After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period
Drug: XP 23829 800 mg QD
active dose 2

Experimental: XP23829 400 mg BID (twice daily)
After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period
Drug: XP23829 400 mg BID
active dose 3

Placebo Comparator: Placebo
After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks
Drug: Placebo
nonactive




Primary Outcome Measures :
  1. • The percent change in PASI (Psoriasis Area and Severity Index) score from Baseline [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. • Proportion of subjects who achieve a reduction of 75% or greater from Baseline in PASI (PASI-75) [ Time Frame: Weeks 2, 4, 8, 12, 14 and 16 ]
  2. • Proportion of subjects who achieve a sPGA (static Physician's Global Assessment) score of clear or almost clear [ Time Frame: Weeks 2, 4, 8, 12, 14 and 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, age ≥ 18.
  2. Stable, moderate-to-severe plaque-type psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator).
  3. Severity of disease meeting all of the following three criteria prior to randomization:

    1. Psoriasis Area and Severity Index (PASI) score of 12 or greater
    2. Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
    3. Static Physician's Global Assessment (sPGA) score of 3 or greater
  4. Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

Exclusion Criteria:

  1. Subjects with current inverse, erythrodermic, predominantly guttate, or pustular psoriasis.
  2. Subjects with current drug-induced or drug-exacerbated psoriasis.
  3. Subjects with moderate-to-severe psoriatic arthritis of any type; and subjects with mild psoriatic arthritis, who require systemic disease-modifying therapy.
  4. Subjects with unstable or significant illness, including the presence of laboratory abnormalities at screening that in the opinion of the investigator would place the subject at unacceptable risk if he/she were to participate in the study.
  5. Any skin condition (e.g. eczema) which confounds the ability to interpret data from the study.
  6. Treatment with a topical anti-psoriatic therapy within 14 days prior to randomization (including topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin).
  7. Phototherapy or prolonged sun exposure or use of ultraviolet (UV) light sources within 28 days of randomization.
  8. Use of investigational or approved biologic treatments that are known to affect psoriasis, such as adalimumab, etanercept, golimumab or infliximab within 12 weeks of randomization and ustekinumab within 24 weeks of randomization.
  9. Use of systemic medications (non-biologics) that are known to affect psoriasis (including but not limited to oral corticosteroids, cyclosporine, methotrexate, lithium, and beta-adrenergic blockers) within 4 weeks of randomization, or 5 half-lives, whichever is longer.
  10. Prior treatment with Dimethyl Fumarate (Fumaderm® or Tecfidera®) or any other Fumaric Acid Ester (FAE) containing products.
  11. Have failed (due to inadequate response) more than 3 approved systemic agents for the treatment of psoriasis.

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): NCT02173301


Locations
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United States, Alabama
XenoPort Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
XenoPort Investigational Site
Phoenix, Arizona, United States, 85032
United States, Arkansas
XenoPort Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
XenoPort Investigational Site
Encinitas, California, United States, 92024
XenoPort Investigational Site
Fremont, California, United States, 94538
XenoPort Investigational Site
Fullerton, California, United States, 92663
United States, Colorado
XenoPort Investigational Site
Denver, Colorado, United States, 80210
United States, Georgia
XenoPort Investigational Site
Snellville, Georgia, United States, 30078
United States, Illinois
XenoPort Investigational Site
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
XenoPort Investigational Site
Carmel, Indiana, United States, 46032
XenoPort Investigational Site
South Bend, Indiana, United States, 46617
United States, Kansas
XenoPort Investigational Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
XenoPort Investigational Site
Louisville, Kentucky, United States, 40217
XenoPort Investigational Site
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
XenoPort Investigational Site
Boston, Massachusetts, United States, 02111
XenoPort Investigational Site
Watertown, Massachusetts, United States, 02472
United States, Michigan
XenoPort Investigational Site
Troy, Michigan, United States, 48084
XenoPort Investigational Site
Warren, Michigan, United States, 48088
United States, Nebraska
XenoPort Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
XenoPort Investigational Site
East Windsor, New Jersey, United States, 08520
XenoPort Investigational Site
Verona, New Jersey, United States, 07044
United States, New York
XenoPort Investigational Site
Rochester, New York, United States, 14623
XenoPort Investigational Site
Stony Brook, New York, United States, 11790
United States, North Carolina
XenoPort Investigational Site
High Point, North Carolina, United States, 27262
United States, Tennessee
XenoPort Investigational Site
Goodlettsville, Tennessee, United States, 37072
United States, Texas
XenoPort Investigational Site
Dallas, Texas, United States, 75230
XenoPort Investigational Site
Dallas, Texas, United States, 75231
XenoPort Investigational Site
Dallas, Texas, United States, 75246
XenoPort Investigational Site
San Antonio, Texas, United States, 78218
XenoPort Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
XenoPort Investigational Site
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
XenoPort, Inc.
Investigators
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Study Director: Dmitri Lissin, M.D. XenoPort, Inc.
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Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT02173301    
Other Study ID Numbers: XP-H-093
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: November 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases