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

If you participate in this clinical trial you will undergo one-day screening during 28 day screening period that includes blood sampling, stool sampling, psoriasis severity assessment, and safety assessments. Once screening is complete, you will be assigned to one of the two groups, where you will take KBL697 or placebo. You will need to visit the study site a total of 7 times including Screening Visit and End of Study Visit. You will also be asked to complete a diary and have blood draws 7 times throughout the study. The total duration of the study is about 20 weeks (4 weeks for screening, 12 weeks for treatment, and 4 weeks for follow-up).

Descriptive trial information

What is this clinical research project about?
You are being asked to take part in this study because you have psoriasis. This study is being done to find out if a new investigational drug KBL697 helps your psoriasis better than other drugs that are currently available and approved to be sold in the market.

There are drugs that are already available to treat your psoriasis that your doctor will use if you do not want to join this research study. Researchers believe that this new KBL697 might work better because it is expected to inhibit allergic and inflammatory responses without systemic side effects.

What will I be asked to do?
You will undergo one-day screening during 28‑day screening period that includes blood sampling, stool sampling, psoriasis severity assessment, and safety assessments. Once screening is complete, you will be assigned to one of the two groups, where you will take KBL697 or placebo. You will need to visit the study site a total of 7 times including Screening Visit and End of Study Visit. You will also be asked to complete a diary and have blood draws 7 times throughout the study. The total duration of the study is about 20 weeks (4 weeks for screening, 12 weeks for treatment, and 4 weeks for follow-up).

What are the possible benefits of this clinical trial?
We hope that KBL697 will improve your condition of psoriasis by inhibiting allergic and inflammatory responses. However, you may not get any direct benefit from taking part in this study. You will be given close attention from the study staff during the time you are involved in the study. You may get information about your health from physical examinations and medical tests done in this study.

This study is expected to benefit the Sponsor by providing information about KBL697.

If the results of this study are favorable and, along with extra studies, lead to approval by the regulatory authorities of KBL697 for use in humans, there may be benefits for patients in the future. These benefits may include the development of a new medication for psoriasis.

What are the possible risks of this clinical trial?
As with all research studies, the study medication and study procedures may involve unknown risks. Any medication can have temporary and permanent side effects and can cause unforeseen adverse reactions.

 

Side Effects of KBL697

This is the second study of KBL697 in humans. In the first study, 36 healthy volunteers received KBL697 as either single dose or multiple doses.

This section describes the possible side effects experienced by healthy volunteers administered KBL697.

  • 1 to 10 out of 100 persons (≥ 1% and < 10%) administered a single dose of KBL697:

o Cough, reduced appetite, and non-specific subjective altered cognition

  • 1 to 10 out of 100 persons (≥ 1% and < 10%) administered multiple doses of KBL697 (twice daily for 14 days):

o  Dizziness, ringing in ears, and feces discoloration

All of the above side effects were mild and resolved without any treatment or change to administration of KBL697.

 Allergic Reaction

There is a risk of allergic reaction, including serious or fatal reaction, with any medication. You will be closely monitored for any signs of symptoms of a reaction. Symptoms of an allergic reaction may include

  • Rash
  • Wheezing and difficulty breathing
  • Dizziness and fainting
  • Swelling around the mouth, throat, or eyes
  • Fast pulse
  • Sweating

Do I have to take part?

It is up to you to decide if you want to take part. Even if you choose not to take part in this study, you will not be disadvantaged in any way, including all medical treatment and care you have the right to receive. If you choose to take part, you may change your mind and choose to leave the study at any time for any reason. You will not need to explain your reasons for leaving the study. If you leave the study, you will not bear any penalty or loss of benefits regarding your future care. You will need to notify the study doctor or study staff verbally.

The study doctor can discontinue the study treatment at any time if you meet any of the following conditions during the study:

  • You start treatment with prohibited concomitant medication(s).
  • The study doctor believes that for safety reasons (e.g., side effects), it is in the best interest of you to discontinue study treatment.
  • You become pregnant or plan a pregnancy during the study.
  • You (or your legally acceptable representative) withdraw consent for administration of study intervention.
  • You have severe hepatic function abnormalities.
  • You are diagnosed with a malignancy.
  • You develop a serious infection, including but not limited to sepsis or pneumonia.

The study doctor can withdraw you from the study at any time if he or she feels it is in your best interest or if you cannot comply with study requirements.

Your participation in the study may also be stopped at any time by the Sponsor (for medical or business reasons), the regulatory authorities, or independent ethics committee such as the Institutional Review Board (IRB) or Institutional Ethics Committee (IEC). These committees ensure that your rights are not violated. The reason(s) for stopping the study will be explained to you, and you will be given advice about continued care for your condition, if this is appropriate.

If you leave (or withdraw from) the study, you will be asked to go through study withdrawal procedures detailed in Section 4 and information about you will be handled as detailed in Section 12.

Will I hear about the results from this clinical trial?

The results of this study may be published in a medical journal and shown at medical meetings. You will not be identified in any of these publications.

What happens to my information if I enter this clinical study?

The data shared with the Sponsor is protected using a code specifically assigned to you. The study doctor is in control of the code needed to connect your personal data to you.

All data that identify you by name will be held confidential and will not be made publicly available. The study doctor, the authorized personnel from the Sponsor and its representatives, the study monitor (who checks how the study is going and makes sure that the information is being collected and used properly) and, under certain circumstances, the regulatory authorities and members of the ethics committees will be able to inspect confidential data that identify you by name. This will be done without violating your confidentiality to the extent permitted by the applicable laws and regulations.

To take part in this study, you will be asked to sign a consent form, through which you will grant permission for personal data and medical information about you obtained during this study (your study data) to be made available to authorized or approved representatives of the regulatory authorities, other government agencies, the Sponsor auditors, the study monitor, other study personnel, and ethics committees.

Blood samples and skin biopsy samples (if available) for detection of biomarker analysis and your stool samples for analysis of gut flora will be sent to the central laboratory which may be outside your own country. Your coded data and study data may be sent to other country(ies) since some of the recipients are based outside of your country. When your personal data is sent to another country, it is either controlled by a contract approved by government agencies supervising protection of your data (data privacy authorities) or by Sponsor’s rules which have been approved by data privacy authorities (called Binding Corporate Rules). Your personal information will still be kept completely confidential, no matter which country it goes to, even if that country does not have the same level of protection for personal information as your current location country.

The data collected during this study, including your personal data, may be further used in analyses by the Sponsor or other researchers to answer additional scientific questions related to KBL697/psoriasis condition. The Sponsor will take appropriate measures to protect your information and will only use and share coded data for such additional research.

Your data may be used by the Sponsor or contract research organization on a coded basis for administrative purposes. For example, such coded data may be used to track the overall progress of this study and to improve the manner in which future clinical trials are conducted. Your data may also be stripped of any information that could be used to identify you or combined with other data by the Sponsor or contract research organization as part of their efforts to protect personal information.

If you withdraw your consent for participating in this study, your personal and study data that were collected before you withdrew your consent may still be used as described above. Once you have withdrawn your consent for participating in the study, no further data will be collected about you for the purposes of this study unless you agree otherwise, for example, you agree to have further tests and examinations. If you do agree to have further data collected after you have withdrawn your consent, these study data may also be used as described above. By signing the consent form, you explicitly agree that if you decide to withdraw from the study, your medical data (and samples) collected prior to withdrawal may still be processed along with other data collected as part of the study. If you prefer any previously retained samples destroyed, you must notify your study doctor in writing.

 

Who can I contact for further information or if I have concerns about this clinical trial?

There are 4 research sites in Australia

Country PAREXEL Site number Primary Investigator Site Personnel First Name Site Personnel Last Name Site Personnel Role PI E-signature and User Name Email Address – Email 1 Survey Email – Email  2 Site Personnel Office Phone
AUSTRALIA 201 Smith Annika Annika Smith Principal Investigator Annika.Smith2@health.nsw.gov.au Annika.Smith2@health.nsw.gov.au +61 2 8890 5686
AUSTRALIA 201 Smith Annika Yang Song Study Coordinator yang.song@health.nsw.gov.au +61 2 8890 3791
AUSTRALIA 202 Murrell Deirdre (Dedee) Deirdre (Dedee) Murrell Principal Investigator d.murrell@unsw.edu.au premierspecnurse@gmail.com +61 2 95985800
AUSTRALIA 202 Murrell Deirdre (Dedee) Bianca Wills Study Coordinator premierspectrialsbianca@gmail.com +61 02 9598 5800
AUSTRALIA 203 Spelman Lynda Lynda Spelman Principal Investigator spelchat@veracity.net.au spelchat@veracity.net.au +61 7 3039 1311
AUSTRALIA 203 Spelman Lynda Kurt Davidson Study Coordinator kdavidson@veracityclinicalresearch.com.au kdavidson@veracityclinicalresearch.com.au +61 730 391 346
AUSTRALIA 204 Eisman Samantha Samantha Eisman Principal Investigator sameisman@gmail.com sameisman@gmail.com +61 (0)3 96542426
AUSTRALIA 204 Eisman Samantha Carolyn De Silva Study Coordinator Carolyn.desilva@sinclairdermatology.com.au 03 9013 0099

 

Trial Information:
Trial Status: recruiting
Date Registered: June 3, 2021
Ethics Application Status: submitted
Anticipated date of first participant enrollment:
Anticipated date of last participant enrollment:
Are Healthy Volunteers able to participate? no
Eligibility:
Key Inclusion Criteria:
Key Exclusion Criteria:
Gender: Male & Female
Minimum Age: 18 year(s)
Maximum Age: 75 year(s)
Other Information:
Contact us to take part in this clinical research study: