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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04911751




Registration number
NCT04911751
Ethics application status
Date submitted
9/05/2021
Date registered
3/06/2021
Date last updated
2/08/2023

Titles & IDs
Public title
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis
Scientific 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
Secondary ID [1] 0 0
KBL-CURE-2020-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Plaque 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KBL697
Treatment: Drugs - KBL697

Experimental: Low dose group - 39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.

Experimental: High dose group - 39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.


Treatment: Drugs: KBL697
1 capsule BID of KBL697 or Placebo

Treatment: Drugs: KBL697
5 capsules BID of KBL697 or Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psoriasis Area and Severity Index (PASI)
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Psoriasis Area and Severity Index (PASI)
Timepoint [1] 0 0
Baseline to Weeks 2, 4 and 8
Secondary outcome [2] 0 0
Psoriasis Area and Severity Index (PASI) -50
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Psoriasis Area and Severity Index (PASI) -75
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Physician's Global Assessment (PGA)
Timepoint [4] 0 0
Baseline to Weeks 4, 8 and 12
Secondary outcome [5] 0 0
Physician's Global Assessment (PGA)
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Psoriasis-Affected Body Surface Area (BSA)
Timepoint [6] 0 0
Baseline to Weeks 4, 8 and 12
Secondary outcome [7] 0 0
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Timepoint [7] 0 0
Baseline to Week 16

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/03/2024
Actual
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialist - Kogarah
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Trials Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
KoBioLabs
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04911751
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ira Thorla
Address 0 0
Louisiana Dermatology Associates
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04911751