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

Purpose

The purpose of the study are:

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.

Condition	Intervention	Phase
Psoriasis	Drug: XP23829 400 mg QD Drug: XP 23829 800 mg QD Drug: XP23829 400 mg BID Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:

• The percent change in PASI (Psoriasis Area and Severity Index) score from Baseline [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

• 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 ]


Enrollment:	200
Study Start Date:	June 2014
Study Completion Date:	August 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 XP23829 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 XP23829 400 mg BID
Placebo Comparator: Placebo After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks	Drug: XP23829 400 mg QD XP23829 400 mg QD Drug: XP 23829 800 mg QD XP23829 800 mg QD Drug: XP23829 400 mg BID XP23829 400 mg BID Drug: Placebo Placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:
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
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173301

Show 31 Study Locations

Sponsors and Collaborators

XenoPort, Inc.

Investigators


Study Director:	Dmitri Lissin, M.D.	XenoPort, Inc.

More Information


Responsible Party:	XenoPort, Inc.
ClinicalTrials.gov Identifier:	NCT02173301 History of Changes
Other Study ID Numbers:	XP-H-093
Study First Received:	June 23, 2014
Last Updated:	September 16, 2015

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017