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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XP23829 400 mg QD
XP 23829 800 mg QD
XP23829 400 mg BID
Placebo
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site
  • XenoPort Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

XP23829 400 mg QD (once daily)

XP23829 800 mg QD

XP23829 400 mg BID (twice daily)

Placebo

Arm Description

After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period

After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period

After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period

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

Outcomes

Primary Outcome Measures

• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Secondary Outcome Measures

• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index score (PASI-75) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear
The Percentage of subjects who achieve the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. Score Grade : Definition - 0 Clear: No signs of psoriasis Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.

Full Information

First Posted
June 23, 2014
Last Updated
March 17, 2022
Sponsor
Dr. Reddy's Laboratories Limited
Collaborators
XenoPort, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02173301
Brief Title
A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
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 Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
Collaborators
XenoPort, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study objectives are the following: To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of moderate-to-severe chronic plaque-type psoriasis. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.
Detailed Description
Study Design : This is a , multi-center, double blind, placebo-controlled, phase 2 (dose-finding) efficacy and safety study in which subjects with moderate-to- severe chronic plaque-type psoriasis will be randomized in a 1:1:1:1 allocation ratio to 1 of 3 active doses of XP23829 or placebo. Approximately 50 subjects will be enrolled into each treatment group. Study Periods: The study includes a 4-week screening phase, a 12-week treatment phase (with 9 weeks of XP23829 or placebo at the maintenance dose), and a 4-week observational post-treatment follow-up phase. A treatment-free follow-up period is designed to evaluate safety and disease relapse and rebound. Specifically, the study periods are as follows: Screening Phase: Weeks -4 through 0 Treatment phase included: Titration Phase: Weeks 1 through 3 Double-Blind Maintenance Phase: Weeks 4 through 12 Post-treatment follow-up: Weeks 13 through 16 Efficacy assessments will be performed in the clinic at Baseline (Visit 2) and at the end of Weeks 2, 4, 8, 12, 14, and 16. Patient-reported outcome measures will be assessed in the clinic at Baseline and at Week 12. Blood samples for pharmacodynamic (PD) assessments will be collected at Baseline and at Weeks 4, 8, 12 and 16. PD assessments will be conducted in all subjects, with the intent of evaluating psoriasis-associated inflammatory markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XP23829 400 mg QD (once daily)
Arm Type
Experimental
Arm Description
After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period
Arm Title
XP23829 800 mg QD
Arm Type
Experimental
Arm Description
After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period
Arm Title
XP23829 400 mg BID (twice daily)
Arm Type
Experimental
Arm Description
After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
XP23829 400 mg QD
Other Intervention Name(s)
Tepilamide fumarate 400 mg QD, PPC-06 400 mg QD
Intervention Description
active dose 1
Intervention Type
Drug
Intervention Name(s)
XP 23829 800 mg QD
Other Intervention Name(s)
Tepilamide fumarate 800 mg QD, PPC-06 800 mg QD
Intervention Description
active dose 2
Intervention Type
Drug
Intervention Name(s)
XP23829 400 mg BID
Other Intervention Name(s)
Tepilamide fumarate 400 mg BID, PPC-06 400 mg BID
Intervention Description
active dose 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
control
Primary Outcome Measure Information:
Title
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
Description
The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)
Description
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index score (PASI-75) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Time Frame
Weeks 2, 4, 8, 12, 14 and 16
Title
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear
Description
The Percentage of subjects who achieve the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. Score Grade : Definition - 0 Clear: No signs of psoriasis Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.
Time Frame
Weeks 2, 4, 8, 12, 14 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects, age ≥ 18. 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). Severity of disease meeting all of the following three criteria prior to randomization: Psoriasis Area and Severity Index (PASI) score of 12 or greater Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater Static Physician's Global Assessment (sPGA) score of 3 or greater Must be a candidate for phototherapy and/or systemic therapy for psoriasis. Exclusion Criteria: Subjects with current inverse, erythrodermic, predominantly guttate, or pustular psoriasis. Subjects with current drug-induced or drug-exacerbated psoriasis. Subjects with moderate-to-severe psoriatic arthritis of any type; and subjects with mild psoriatic arthritis, who require systemic disease-modifying therapy. 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. Any skin condition (e.g. eczema) which confounds the ability to interpret data from the study. 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). Phototherapy or prolonged sun exposure or use of ultraviolet (UV) light sources within 28 days of randomization. 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. 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. Prior treatment with Dimethyl Fumarate (Fumaderm® or Tecfidera®) or any other Fumaric Acid Ester (FAE) containing products. Have failed (due to inadequate response) more than 3 approved systemic agents for the treatment of psoriasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Lissin, M.D.
Organizational Affiliation
XenoPort, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
XenoPort Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
XenoPort Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
XenoPort Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
XenoPort Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
XenoPort Investigational Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
XenoPort Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
XenoPort Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
XenoPort Investigational Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
XenoPort Investigational Site
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
XenoPort Investigational Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
XenoPort Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
XenoPort Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
XenoPort Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
XenoPort Investigational Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
XenoPort Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
XenoPort Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
XenoPort Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
XenoPort Investigational Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
XenoPort Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
XenoPort Investigational Site
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
XenoPort Investigational Site
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
XenoPort Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
XenoPort Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
XenoPort Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
XenoPort Investigational Site
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
XenoPort Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
XenoPort Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
XenoPort Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
XenoPort Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
XenoPort Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
XenoPort Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

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

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