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

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

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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

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

Drug: KBL697