A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | June 2014 |
End Date: | August 2015 |
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 purpose of the study are:
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.
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.
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:
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 steroids, 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 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.
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.
We found this trial at
31
sites
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