Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| XenoPort, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study objectives are the following:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP23829 400 mg QD (once daily) | Experimental | After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period |
|
| XP23829 800 mg QD | Experimental | After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period |
|
| XP23829 400 mg BID (twice daily) | Experimental | After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period |
|
| Placebo | Placebo Comparator | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XP23829 400 mg QD | Drug | active dose 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| • 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. |
Not provided
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:
Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dmitri Lissin, M.D. | XenoPort, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XenoPort Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| XenoPort Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 XP23829 400 mg QD: active dose 1 |
| FG001 | XP23829 800 mg QD (Once Daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| XP 23829 800 mg QD | Drug | active dose 2 |
|
|
| XP23829 400 mg BID | Drug | active dose 3 |
|
|
| Placebo | Drug | control |
|
| 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 | 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
A lower score on this scale at the end of the study indicates an improvement in the disease condition. | Weeks 2, 4, 8, 12, 14 and 16 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| XenoPort Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| XenoPort Investigational Site | Encinitas | California | 92024 | United States |
| XenoPort Investigational Site | Fremont | California | 94538 | United States |
| XenoPort Investigational Site | Fullerton | California | 92663 | United States |
| XenoPort Investigational Site | Denver | Colorado | 80210 | United States |
| XenoPort Investigational Site | Snellville | Georgia | 30078 | United States |
| XenoPort Investigational Site | Buffalo Grove | Illinois | 60089 | United States |
| XenoPort Investigational Site | Carmel | Indiana | 46032 | United States |
| XenoPort Investigational Site | South Bend | Indiana | 46617 | United States |
| XenoPort Investigational Site | Overland Park | Kansas | 66215 | United States |
| XenoPort Investigational Site | Louisville | Kentucky | 40217 | United States |
| XenoPort Investigational Site | Owensboro | Kentucky | 42303 | United States |
| XenoPort Investigational Site | Boston | Massachusetts | 02111 | United States |
| XenoPort Investigational Site | Watertown | Massachusetts | 02472 | United States |
| XenoPort Investigational Site | Troy | Michigan | 48084 | United States |
| XenoPort Investigational Site | Warren | Michigan | 48088 | United States |
| XenoPort Investigational Site | Omaha | Nebraska | 68114 | United States |
| XenoPort Investigational Site | East Windsor | New Jersey | 08520 | United States |
| XenoPort Investigational Site | Verona | New Jersey | 07044 | United States |
| XenoPort Investigational Site | Rochester | New York | 14623 | United States |
| XenoPort Investigational Site | Stony Brook | New York | 11790 | United States |
| XenoPort Investigational Site | High Point | North Carolina | 27262 | United States |
| XenoPort Investigational Site | Goodlettsville | Tennessee | 37072 | United States |
| XenoPort Investigational Site | Dallas | Texas | 75230 | United States |
| XenoPort Investigational Site | Dallas | Texas | 75231 | United States |
| XenoPort Investigational Site | Dallas | Texas | 75246 | United States |
| XenoPort Investigational Site | San Antonio | Texas | 78218 | United States |
| XenoPort Investigational Site | San Antonio | Texas | 78229 | United States |
| XenoPort Investigational Site | West Jordan | Utah | 84088 | United States |
After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2 |
| FG002 | 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 XP23829 400 mg BID: active dose 3 |
| FG003 | Placebo | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 XP23829 400 mg QD: active dose 1 |
| BG001 | XP23829 800 mg QD (Once Daily) | After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2 |
| BG002 | 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 XP23829 400 mg BID: active dose 3 |
| BG003 | Placebo | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline PASI score | 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. PASI score assessed at Baseline Visit | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline sPGA | 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 sPGA atbaseline | Count of Participants | Participants |
| |||||||||||||||
| Baseline Body Surface Area involved | Percentage of the subject's total body surface area (BSA) that is involved by lesions of plaque psoriasis . Percentage of total BSA involved by psoriasis lesions at Baseline | Mean | Standard Deviation | percentage |
| ||||||||||||||
| Has Used Systemic Biologics? | Subjects who have used one or more systemic biologic treatment(s) for their plaque psoriasis in the past. This information is collected at Screening/ Baseline Visit | Count of Participants | Participants |
| |||||||||||||||
| Body Weight | Subject's body weight as of Baseline Visit | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | • 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. | modified Intent-to-Treat population Observed cases analysis | Posted | Least Squares Mean | Standard Error | percentage change from baseline | 12 Weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | • 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. | modified Intent-to-treat population with last observation carried forward imputation for missing values | Posted | Count of Participants | Participants | Weeks 2, 4, 8, 12, 14 and 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | • 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
A lower score on this scale at the end of the study indicates an improvement in the disease condition. | modified 'Intent-to-treat' population using Last Observation Carried Forward method to impute missing observations | Posted | Count of Participants | Participants | Weeks 2, 4, 8, 12, 14 and 16 |
|
Baseline to Week 16 or study discontinuation
Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 XP23829 400 mg QD: active dose 1 | 0 | 49 | 1 | 49 | 36 | 49 |
| EG001 | XP23829 800 mg QD (Once Daily) | After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2 | 0 | 55 | 1 | 55 | 42 | 55 |
| EG002 | 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 XP23829 400 mg BID: active dose 3 | 0 | 48 | 1 | 48 | 37 | 48 |
| EG003 | Placebo | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control | 0 | 48 | 0 | 48 | 29 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Adhesions | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
Any publication would have to be collaborative effort between Sponsor and Investigators
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srinivas Shenoy B., | Dr Reddy's Laboratories Ltd. | 49002900 | srinivassshenoyb@drreddys.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 4 Severe |
|
| Yes |
|
Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate |
| 0.001 |
| Superiority |
| Mixed Models Analysis | Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate | <0.001 | Superiority |
After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3 |
| OG003 | Placebo | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control |
|
|
|
After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period
XP 23829 800 mg QD: active dose 2
| OG002 | 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 XP23829 400 mg BID: active dose 3 |
| OG003 | Placebo | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control |
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|