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OpenTrials
Completed

NCT Number: NCT04911751

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

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.

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Key information

Conditions

Psoriatic Plaque

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premier Specialist, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KBL697

Drug

1 capsule BID of KBL697 or Placebo

Primary outcomes

  1. Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline to Week 12

    Change from Baseline in PASI score

Secondary outcomes

  1. Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline to Weeks 2, 4 and 8

    Change from Baseline in PASI score

  2. Psoriasis Area and Severity Index (PASI) -50

    Time frame: Baseline to Week 12

    Percent of patients who achieved PASI-50

  3. Psoriasis Area and Severity Index (PASI) -75

    Time frame: Baseline to Week 12

    Percent of patients who achieved PASI-75

  4. Physician's Global Assessment (PGA)

    Time frame: Baseline to Weeks 4, 8 and 12

    Change from Baseline in PGA score

  5. Physician's Global Assessment (PGA)

    Time frame: Week 12

    Percent of patients who achieve PGA score of 0 or 1

  6. Psoriasis-Affected Body Surface Area (BSA)

    Time frame: Baseline to Weeks 4, 8 and 12

    Change from Baseline in Psoriasis-Affected BSA

  7. Safety measure through incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

KoBioLabs

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 3, 2021
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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