A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis

Conditions
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Psoriatic Plaque

Intervention / Treatment
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* Drug: KBL697
* Drug: KBL697


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo. | Drug: KBL697<br>* 1 capsule BID of KBL697 or Placebo<br>|
| Experimental: High dose group<br>39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo. | Drug: KBL697<br>* 5 capsules BID of KBL697 or Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) | Change from Baseline in PASI score | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) | Change from Baseline in PASI score | Baseline to Weeks 2, 4 and 8 | 
| Psoriasis Area and Severity Index (PASI) -50 | Percent of patients who achieved PASI-50 | Baseline to Week 12 | 
| Psoriasis Area and Severity Index (PASI) -75 | Percent of patients who achieved PASI-75 | Baseline to Week 12 | 
| Physician's Global Assessment (PGA) | Change from Baseline in PGA score | Baseline to Weeks 4, 8 and 12 | 
| Physician's Global Assessment (PGA) | Percent of patients who achieve PGA score of 0 or 1 | Week 12 | 
| Psoriasis-Affected Body Surface Area (BSA) | Change from Baseline in Psoriasis-Affected BSA | Baseline to Weeks 4, 8 and 12 | 
| Safety measure through incidence of treatment-emergent adverse events (TEAEs) | 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. | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, KBL697, Plaque psoriasis