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

NCT02173301 | Completed Phase 2 Results

• 1 other identifier: XP-H-093
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 31

Brief Summary

The study objectives are the following:

1. 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. 2.To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.
3. 3.To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.

Conditions

Psoriasis

Outcome Measures

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.

  12 Weeks

Secondary Outcomes (2)

• • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)

  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

  Weeks 2, 4, 8, 12, 14 and 16

Study Arms (4)

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

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

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

Drug: XP23829 400 mg BID

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XP23829 400 mg QD DRUG

active dose 1

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

XP23829 400 mg QD (once daily)

XP 23829 800 mg QD DRUG

active dose 2

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

XP23829 800 mg QD

XP23829 400 mg BID DRUG

active dose 3

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

XP23829 400 mg BID (twice daily)

Placebo DRUG

control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• XenoPort, Inc.: collaborator

Study Sites (31)

XenoPort Investigational Site

Birmingham, Alabama, 35233, United States

Location

XenoPort Investigational Site

Phoenix, Arizona, 85032, United States

Location

XenoPort Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

XenoPort Investigational Site

Encinitas, California, 92024, United States

Location

XenoPort Investigational Site

Fremont, California, 94538, United States

Location

XenoPort Investigational Site

Fullerton, California, 92663, United States

Location

XenoPort Investigational Site

Denver, Colorado, 80210, United States

Location

XenoPort Investigational Site

Snellville, Georgia, 30078, United States

Location

XenoPort Investigational Site

Buffalo Grove, Illinois, 60089, United States

Location

XenoPort Investigational Site

Carmel, Indiana, 46032, United States

Location

XenoPort Investigational Site

South Bend, Indiana, 46617, United States

Location

XenoPort Investigational Site

Overland Park, Kansas, 66215, United States

Location

XenoPort Investigational Site

Louisville, Kentucky, 40217, United States

Location

XenoPort Investigational Site

Owensboro, Kentucky, 42303, United States

Location

XenoPort Investigational Site

Boston, Massachusetts, 02111, United States

Location

XenoPort Investigational Site

Watertown, Massachusetts, 02472, United States

Location

XenoPort Investigational Site

Troy, Michigan, 48084, United States

Location

XenoPort Investigational Site

Warren, Michigan, 48088, United States

Location

XenoPort Investigational Site

Omaha, Nebraska, 68114, United States

Location

XenoPort Investigational Site

East Windsor, New Jersey, 08520, United States

Location

XenoPort Investigational Site

Verona, New Jersey, 07044, United States

Location

XenoPort Investigational Site

Rochester, New York, 14623, United States

Location

XenoPort Investigational Site

Stony Brook, New York, 11790, United States

Location

XenoPort Investigational Site

High Point, North Carolina, 27262, United States

Location

XenoPort Investigational Site

Goodlettsville, Tennessee, 37072, United States

Location

XenoPort Investigational Site

Dallas, Texas, 75230, United States

Location

XenoPort Investigational Site

Dallas, Texas, 75231, United States

Location

XenoPort Investigational Site

Dallas, Texas, 75246, United States

Location

XenoPort Investigational Site

San Antonio, Texas, 78218, United States

Location

XenoPort Investigational Site

San Antonio, Texas, 78229, United States

Location

XenoPort Investigational Site

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Srinivas Shenoy B.,
• Organization: Dr Reddy's Laboratories Ltd.

srinivassshenoyb@drreddys.com

49002900

Study Officials

• Dmitri Lissin, M.D.

  XenoPort, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2017-11

Locations

US (31)