Psoriasis
Conditions
Keywords
Moderate to Severe Plaque Psoriasis
Brief summary
A Study looking at the safety and efficacy of D-2570 in Participants with Plaque Psoriasis
Detailed description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Participants with Moderate to Severe Plaque Psoriasis
Interventions
DRUGD-2570 Tablet
Active Treatment
DRUGPlacebo Tablets
Identical Tablet
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of plaque psoriasis with no significant flares of disease activity for at least 6 months before signing the informed consent * Participants have moderate to severe plaque psoriasis as defined by a total body surface area (BSA) ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥ 12 and a Physician's Global Assessment (PGA) score ≥ 3. * Within normal ranges of laboratory assessments
Exclusion criteria
* Any comorbidities or past medical conditions as outlined in the protocol that would interfere with study assessments as deemed by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in PASI-90 | Assessment completed after 12 weeks of treatment/placebo | Proportion of participants achieving at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12 |
Countries
United States
Contacts
CONTACTKathryn Stazzone
Outcome results
None listed