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CompletedNCT02173301Updated Apr 12, 2022Results posted

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

A Phase 2 interventional study of XP23829 400 mg QD and XP 23829 800 mg QD in Psoriasis, sponsored by Dr. Reddy's Laboratories Limited. Completed at 31 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study objectives are the following:

  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.
Read the 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:

  1. Screening Phase: Weeks -4 through 0

  2. Treatment phase included:

    1. Titration Phase: Weeks 1 through 3
    2. Double-Blind Maintenance Phase: Weeks 4 through 12
  3. 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 200 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Browse Dr. Reddy's Laboratories Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugXP23829 400 mg QD

    active dose 1

    Also known as: Tepilamide fumarate 400 mg QD, PPC-06 400 mg QD

  • DrugXP 23829 800 mg QD

    active dose 2

    Also known as: Tepilamide fumarate 800 mg QD, PPC-06 800 mg QD

  • DrugXP23829 400 mg BID

    active dose 3

    Also known as: Tepilamide fumarate 400 mg BID, PPC-06 400 mg BID

  • DrugPlacebo

    control

06

What researchers measure

Primary outcomes

  1. • 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.

    Time frame: 12 Weeks

Secondary outcomes

  1. • 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.

    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

    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 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. 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

07

Results

Posted Apr 12, 2022

Participant flow

Participant flow — Overall Study
MilestoneXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
Started49554848
Completed29322833
Not completed20232015
Withdrew: Adverse event78135
Withdrew: Withdrawal by subject81048
Withdrew: Lost to follow-up4422
Withdrew: Protocol violation0100
Withdrew: Physician decision0010
Withdrew: Subject unable to return for week 16 assessment within sponsor timelines for study completion1000

Outcome measures

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.

Time frame:
12 Weeks
Reported as:
Least squares mean · percentage change from baseline
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
percentage change from baselineXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline-38.1 ± 5.07-48.2 ± 5.06-50.7 ± 5.50-25.0 ± 5.06
Statistical analysis
  • XP23829 400 mg QD (Once Daily) vs Placebo · Mixed Models Analysis · p = 0.066Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate
  • XP23829 800 mg QD (Once Daily) vs Placebo · Mixed Models Analysis · p = 0.001Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate
  • XP23829 400 mg BID (Twice Daily) vs Placebo · Mixed Models Analysis · p = <0.001Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate
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.

Time frame:
Weeks 2, 4, 8, 12, 14 and 16
Reported as:
Count of participants · Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)
ParticipantsXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
Week 21000
Week 42020
Week 83252
Week 1267104
Week 146463
Week 163362
Statistical analysis
  • XP23829 400 mg QD (Once Daily) vs Placebo · Regression, Logistic · p = 0.501
  • XP23829 800 mg QD (Once Daily) vs Placebo · Regression, Logistic · p = 0.340
  • XP23829 400 mg BID (Twice Daily) vs Placebo · Regression, Logistic · p = 0.075
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 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. 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
Reported as:
Count of participants · Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear
ParticipantsXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
Week 20000
Week 41100
Week 82212
Week 125332
Week 145231
Week 165141
Statistical analysis
  • XP23829 400 mg QD (Once Daily) vs Placebo · Regression, Logistic · p = 0.229
  • XP23829 800 mg QD (Once Daily) vs Placebo · Regression, Logistic · p = 0.604
  • XP23829 400 mg BID (Twice Daily) vs Placebo · Regression, Logistic · p = 0.573

Adverse events

Collected over Baseline to Week 16 or study discontinuation. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
XP23829 400 mg QD (Once Daily)0/49 (0%)1/49 (2%)36/49 (73.5%)
XP23829 800 mg QD (Once Daily)0/55 (0%)1/55 (1.8%)42/55 (76.4%)
XP23829 400 mg BID (Twice Daily)0/48 (0%)1/48 (2.1%)37/48 (77.1%)
Placebo0/48 (0%)0/48 (0%)29/48 (60.4%)
Most frequent serious events
Most frequent serious events
EventXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
EnterocolitisGastrointestinal disorders0/490/551/480/48
Abdominal AdhesionsGastrointestinal disorders1/490/550/48—
Abdominal herniaGastrointestinal disorders1/490/550/480/48
Small intestinal obstructionGastrointestinal disorders1/490/550/480/48
Cholecystitis acuteHepatobiliary disorders0/491/550/480/48
Most frequent other events
Showing 10 of 16
Most frequent other events
EventXP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)Placebo
DiarrheaGastrointestinal disorders11/4922/5519/487/48
Abdominal painGastrointestinal disorders1/497/5511/482/48
NauseaGastrointestinal disorders6/494/5510/486/48
VomitingGastrointestinal disorders3/497/551/481/48
HeadacheNervous system disorders2/493/555/482/48
FlatulenceGastrointestinal disorders2/495/553/480/48
ConstipationGastrointestinal disorders2/490/554/480/48
FlushingVascular disorders4/493/552/483/48
NasopharyngitisRespiratory, thoracic and mediastinal disorders1/494/552/482/48
EosinophiliaBlood and lymphatic system disorders0/494/552/480/48

Baseline characteristics

Age, Continuous
Age, Continuous(years)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
Mean50.8 ± 11.8947.7 ± 10.5551.8 ± 13.8051.1 ± 13.6650.3 ± 12.49
Sex: Female, Male
Sex: Female, Male(Participants)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
Female1723161470
Male32323234130
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
Hispanic or Latino12711131
Not Hispanic or Latino37483747169
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
American Indian or Alaska Native01113
Asian02013
Native Hawaiian or Other Pacific Islander00000
Black or African American431210
White44484544181
More than one race11103
Unknown or Not Reported00000
Baseline PASI score
Baseline PASI score(units on a scale)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
Mean18.32 ± 7.41318.19 ± 7.97717.51 ± 4.79119.13 ± 7.67118.28 ± 7.082
Baseline sPGA
Baseline sPGA(Participants)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
3 Moderate32393434139
4 Severe1716141461
Baseline Body Surface Area involved
Baseline Body Surface Area involved(percentage)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
Mean22.90 ± 13.32423.79 ± 15.28323.08 ± 14.58526.44 ± 16.26024.04 ± 14.860
Has Used Systemic Biologics?
Has Used Systemic Biologics?(Participants)XP23829 400 mg QD (Once Daily)XP23829 800 mg QD (Once Daily)XP23829 400 mg BID (Twice Daily)PlaceboTotal
No32343035131
Yes1721181369

1 further baseline measures are reported on the registry.

08

Study locations

31 sites
  • XenoPort Investigational Site
    Birmingham, Alabama 35233, United States
  • XenoPort Investigational Site
    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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02173301
Lead sponsor
Dr. Reddy's Laboratories Limited
Collaborators
XenoPort, Inc.
Responsible party
Sponsor
First posted
Jun 24, 2014
Start date
Jun 2014
Primary completion
May 2015
Completion
Aug 2015
Results posted
Apr 12, 2022
Last update
Apr 12, 2022

Study contacts

Dmitri Lissin, M.D.
study director · XenoPort, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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