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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.

Tracking Information
First Submitted Date  ICMJE June 23, 2014
First Posted Date  ICMJE June 24, 2014
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
• The percent change in PASI (Psoriasis Area and Severity Index) score from Baseline [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • • 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 ]
  • • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: XP23829 400 mg QD
    active dose 1
  • Drug: XP 23829 800 mg QD
    active dose 2
  • Drug: XP23829 400 mg BID
    active dose 3
  • Drug: Placebo
    nonactive
Study Arms  ICMJE
  • 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
    Intervention: Drug: XP23829 400 mg QD
  • 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
    Intervention: Drug: XP 23829 800 mg QD
  • 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
    Intervention: Drug: XP23829 400 mg BID
  • Placebo Comparator: Placebo
    After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02173301
Other Study ID Numbers  ICMJE XP-H-093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XenoPort, Inc.
Study Sponsor  ICMJE XenoPort, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dmitri Lissin, M.D. XenoPort, Inc.
PRS Account XenoPort, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP