PsoriasisPhase 2NCT02173301
A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
A Phase 2 study testing XP23829 400 mg QD, XP 23829 800 mg QD and XP23829 400 mg BID in people with Psoriasis, run by Dr. Reddy's Laboratories Limited at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- XP23829 400 mg QD, XP 23829 800 mg QD and XP23829 400 mg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2014to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
XenoPort Investigational Site
Birmingham, Alabama, 35233
XenoPort Investigational Site
Boston, Massachusetts, 02111
XenoPort Investigational Site
Buffalo Grove, Illinois, 60089
XenoPort Investigational Site
Carmel, Indiana, 46032
XenoPort Investigational Site
Dallas, Texas, 75230
XenoPort Investigational Site
Dallas, Texas, 75231
XenoPort Investigational Site
Dallas, Texas, 75246
XenoPort Investigational Site
Denver, Colorado, 80210
XenoPort Investigational Site
East Windsor, New Jersey, 08520
XenoPort Investigational Site
Encinitas, California, 92024
XenoPort Investigational Site
Fremont, California, 94538
XenoPort Investigational Site
Fullerton, California, 92663
XenoPort Investigational Site
Goodlettsville, Tennessee, 37072
XenoPort Investigational Site
High Point, North Carolina, 27262
XenoPort Investigational Site
Hot Springs, Arkansas, 71913
XenoPort Investigational Site
Louisville, Kentucky, 40217
XenoPort Investigational Site
Omaha, Nebraska, 68114
XenoPort Investigational Site
Overland Park, Kansas, 66215
XenoPort Investigational Site
Owensboro, Kentucky, 42303
XenoPort Investigational Site
Phoenix, Arizona, 85032
XenoPort Investigational Site
Rochester, New York, 14623
XenoPort Investigational Site
San Antonio, Texas, 78218
XenoPort Investigational Site
San Antonio, Texas, 78229
XenoPort Investigational Site
Snellville, Georgia, 30078
XenoPort Investigational Site
South Bend, Indiana, 46617
XenoPort Investigational Site
Stony Brook, New York, 11790
XenoPort Investigational Site
Troy, Michigan, 48084
XenoPort Investigational Site
Verona, New Jersey, 07044
XenoPort Investigational Site
Warren, Michigan, 48088
XenoPort Investigational Site
Watertown, Massachusetts, 02472
XenoPort Investigational Site
West Jordan, Utah, 84088
About this study
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
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.
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:
- 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.
- Conditions
- Psoriasis
- Being tested
- XP23829 400 mg QD, XP 23829 800 mg QD, XP23829 400 mg BID, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP23829 400 mg QDDrug
Also called Tepilamide fumarate 400 mg QD, PPC-06 400 mg QD
active dose 1
XP 23829 800 mg QDDrug
Also called Tepilamide fumarate 800 mg QD, PPC-06 800 mg QD
active dose 2
XP23829 400 mg BIDDrug
Also called Tepilamide fumarate 400 mg BID, PPC-06 400 mg BID
active dose 3
PlaceboDrug
control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: XP23829 400 mg QD |
| 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 Receives: Drug: XP 23829 800 mg QD |
| 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 Receives: Drug: XP23829 400 mg BID |
| Placebo | Placebo comparator | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 12 Weeks
Secondary outcomes (2)
• 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.
Measured: 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
- 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.
Measured: Weeks 2, 4, 8, 12, 14 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- XenoPort, Inc.
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, M.D., Study director, XenoPort, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173301
- Sponsor's protocol ID
- XP-H-093
- Status last verified
- Nov 2017
- First submitted
- 23 Jun 2014
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02173301
- Acronym / sponsor ID
- XP-H-093
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- XenoPort, Inc.
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 12 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XP23829 400 mg QD (once daily) | Experimental | Drug: XP23829 400 mg QDAfter 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 | Drug: XP 23829 800 mg QDAfter 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 | Drug: XP23829 400 mg BIDAfter 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period |
| Placebo | Placebo comparator | Drug: PlaceboAfter 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XP23829 400 mg QDAlso: Tepilamide fumarate 400 mg QD, PPC-06 400 mg QDactive dose 1 | Drug | XP23829 400 mg QD (once daily) |
| XP 23829 800 mg QDAlso: Tepilamide fumarate 800 mg QD, PPC-06 800 mg QDactive dose 2 | Drug | XP23829 800 mg QD |
| XP23829 400 mg BIDAlso: Tepilamide fumarate 400 mg BID, PPC-06 400 mg BIDactive dose 3 | Drug | XP23829 400 mg BID (twice daily) |
| Placebocontrol | Drug | Placebo |
Primary outcome
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
Time frame: 12 Weeks
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.
2 secondary outcomes
• 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin, M.D. study director
XenoPort, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XP23829 400 mg QD, XP 23829 800 mg QD and XP23829 400 mg BID in people with Psoriasis, run by Dr. Reddy's Laboratories Limited at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.