NCT04911751

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2021

Typical duration for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

May 9, 2021

Last Update Submit

January 5, 2025

Conditions

Psoriatic Plaque

Keywords

microbiomeKBL697Plaque psoriasis

Outcome Measures

Primary Outcomes (1)

  • Psoriasis Area and Severity Index (PASI)

    Change from Baseline in PASI score

    Baseline to Week 12

Secondary Outcomes (7)

  • Psoriasis Area and Severity Index (PASI)

    Baseline to Weeks 2, 4 and 8

  • Psoriasis Area and Severity Index (PASI) -50

    Baseline to Week 12

  • Psoriasis Area and Severity Index (PASI) -75

    Baseline to Week 12

  • Physician's Global Assessment (PGA)

    Baseline to Weeks 4, 8 and 12

  • Physician's Global Assessment (PGA)

    Week 12

  • +2 more secondary outcomes

Study Arms (2)

Low dose group

EXPERIMENTAL

39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.

Drug: KBL697

High dose group

EXPERIMENTAL

39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.

Drug: KBL697

Interventions

KBL697DRUG

1 capsule BID of KBL697 or Placebo

Low dose group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Southern California Dermatology, Inc

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Revival Research Institute

Doral, Florida, 33122, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Louisiana Dermatology Associates - Dermatology

Baton Rouge, Louisiana, 70809, United States

Location

Premier Specialist

Kogarah, New South Wales, 2217, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Veracity Clinical Trials Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Study Officials

  • Ira Thorla

    Louisiana Dermatology Associates

    PRINCIPAL INVESTIGATOR

  • Jose Cardona

    Indago Research and Health Center

    PRINCIPAL INVESTIGATOR

  • Jennifer Soung

    Southern California Dermatology, Inc

    PRINCIPAL INVESTIGATOR

  • James Krell

    Total Skin and Beauty Dermatology Center

    PRINCIPAL INVESTIGATOR

  • Paul Yamauchi

    Clinical Science Institute

    PRINCIPAL INVESTIGATOR

  • Ivette Espinosa-Fernandez

    Revival Research Institute

    PRINCIPAL INVESTIGATOR

  • Annika Smith

    Westmead Hospital

    PRINCIPAL INVESTIGATOR

  • Deirdre Murrell

    Premier Specialist

    PRINCIPAL INVESTIGATOR

  • Lynda Spelman

    Veracity Clinical Trials Ltd

    PRINCIPAL INVESTIGATOR

  • Samantha Eisman

    Sinclair Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2021

First Posted

June 3, 2021

Study Start

November 8, 2021

Primary Completion

November 8, 2023

Study Completion

October 7, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)US(6)