Psoriatic Plaque
Conditions
Keywords
microbiome, KBL697, Plaque psoriasis
Brief summary
The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.
Interventions
DRUGKBL697
1 capsule BID of KBL697 or Placebo
Sponsors
KoBioLabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 to 75 years (inclusive) * Have a diagnosis of plaque type psoriasis for ≥ 6 months * Must have chronic plaque type psoriasis of moderate severity * All subjects must agree and commit to the use of a reliable contraceptive regimen.
Exclusion criteria
* Current diagnosis of forms of psoriasis other than chronic plaque type only * Drug-induced psoriasis * Other inflammatory skin disease that may confound the evaluation of plaque psoriasis * Failed 2 or more systemic treatments for plaque psoriasis * Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | Baseline to Week 12 | Change from Baseline in PASI score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) -50 | Baseline to Week 12 | Percent of patients who achieved PASI-50 |
| Psoriasis Area and Severity Index (PASI) -75 | Baseline to Week 12 | Percent of patients who achieved PASI-75 |
| Psoriasis Area and Severity Index (PASI) | Baseline to Weeks 2, 4 and 8 | Change from Baseline in PASI score |
| Psoriasis-Affected Body Surface Area (BSA) | Baseline to Weeks 4, 8 and 12 | Change from Baseline in Psoriasis-Affected BSA |
| Safety measure through incidence of treatment-emergent adverse events (TEAEs) | Baseline to Week 16 | The number of patients experiencing TEAEs and number of individual TEAEs will be summarized among treatment arms, by system organ class (SOC) and PT. TEAEs will also be summarized among treatment arms, by severity and by relationship to study drug. |
| Physician's Global Assessment (PGA) | Baseline to Weeks 4, 8 and 12 | Change from Baseline in PGA score |
Countries
Australia, United States
Outcome results
None listed