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The trial is taking place at:
S

Sinclair Dermatology | East Melbourne, Australia

Veeva-enabled site

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

K

KoBioLabs

Status and phase

Active, not recruiting
Phase 2

Conditions

Psoriatic Plaque

Treatments

Drug: KBL697

Study type

Interventional

Funder types

Industry

Identifiers

NCT04911751
KBL-CURE-2020-02

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Low dose group
Experimental group
Description:
39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
Treatment:
Drug: KBL697
High dose group
Experimental group
Description:
39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.
Treatment:
Drug: KBL697

Trial contacts and locations

10

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Central trial contact

Sangwoo Lee

Data sourced from clinicaltrials.gov

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