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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04911751
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

KoBioLabs
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ira ThorlaJose CardonaJennifer SoungJames KrellPaul YamauchiDelilah AlonsoAnnika SmithDeirdre MurrellLynda SpelmanSamantha Eisman
Principal Investigator Affiliation Louisiana Dermatology AssociatesIndago Research and Health CenterSouthern California Dermatology, IncTotal Skin and Beauty Dermatology CenterClinical Science InstituteRevival Research InstituteWestmead HospitalPremier SpecialistVeracity Clinical Trials LtdSinclair Dermatology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Plaque
Arms & Interventions

Arms

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.

Interventions

Drug: - KBL697

1 capsule BID of KBL697 or Placebo

Drug: - KBL697

5 capsules BID of KBL697 or Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Total Skin and Beauty Dermatology Center, Birmingham, Alabama

Status

Not yet recruiting

Address

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35205

Site Contact

Angela Powell

[email protected]

+82 2 8889964

Southern California Dermatology, Inc, Santa Ana, California

Status

Not yet recruiting

Address

Southern California Dermatology, Inc

Santa Ana, California, 92701

Site Contact

Madeleine Supranowicz

[email protected]

+82 2 8889964

Clinical Science Institute, Santa Monica, California

Status

Not yet recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Site Contact

Rickie Patnaik

[email protected]

+82 2 8889964

Revival Research Institute, Doral, Florida

Status

Not yet recruiting

Address

Revival Research Institute

Doral, Florida, 33122

Site Contact

Hansell Leyva

[email protected]

+82 2 8889964

Indago Research and Health Center, Hialeah, Florida

Status

Not yet recruiting

Address

Indago Research and Health Center

Hialeah, Florida, 33012

Site Contact

Diana Sosa

[email protected]

+82 2 8889964

Baton Rouge, Louisiana

Status

Not yet recruiting

Address

Louisiana Dermatology Associates - Dermatology

Baton Rouge, Louisiana, 70809

Site Contact

Kandice Lemoine

[email protected]

+82 2 8889964

International Sites

Premier Specialist, Kogarah, New South Wales, Australia

Status

Recruiting

Address

Premier Specialist

Kogarah, New South Wales, 2217

Site Contact

Bianca Wills

[email protected]

+82 2 8889964

Westmead Hospital, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Site Contact

Rupal Patel

[email protected]

+82 2 8889964

Veracity Clinical Trials Ltd, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Veracity Clinical Trials Ltd

Woolloongabba, Queensland, 4102

Site Contact

Madeleine Supranowicz

[email protected]

+82 2 8889964

Sinclair Dermatology, East Melbourne, Victoria, Australia

Status

Not yet recruiting

Address

Sinclair Dermatology

East Melbourne, Victoria, 3002

Site Contact

Dipesh Kumar

[email protected]

+82 2 8889964

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.