Participate in research

Research: Participate in a birch allergy study

A birch allergy study is underway at Cliantha Research in Mississauga, Ontario. They are seeking healthy adults to participate in this study.

As there is cross-reactivity with birch pollen and certain fresh fruits, vegetables and tree nuts, some members in the food allergy community who may also have a birch allergy might be interested in this study or know affected individuals who could be interested.

Following is the announcement from the research team for your information and for sharing with individuals with birch allergy.

From the research team:

Enrolling participants for a birch allergy study

Clinical trial at Cliantha Research

Cliantha Research in Mississauga, Ontario is enrolling participants for a birch allergy study. Our experienced research team, led by Dr. Patricia Couroux, is working closely with pharmaceutical organizations to explore therapies for people with birch allergies.

What is the purpose of this study?

The study is researching study drugs called REGN5713, REGN5714, and REGN5715 in different combinations with each other to understand whether more antibodies, as compared to fewer antibodies or a single antibody, provide greater improvement in nose and eye allergy symptoms due to birch pollen allergy in adults. The aim of the study is to see how effective the study drugs are at reducing allergic nose and eye symptoms. Allergic symptoms will be observed in an Environmental Exposure Unit (EEU) (both during and not during the birch pollen season) and during the natural birch pollen season. Allergic nasal symptoms can include congestion, runny nose, and sneezing. Allergic eye symptoms can include redness, itching, and swelling.

What are REGN5713-5714-5715, REGN5713-5715, and REGN5715?

REGN5713, REGN5714, and REGN5715 are investigational monoclonal antibodies. Antibodies are proteins produced by the body to fight against different types of disease. REGN5713, REGN5714, and REGN5715 are produced in a laboratory and bind to Bet v 1. Bet v 1 is a part of birch pollen that makes most people who are allergic to birch pollen have allergy symptoms. REGN5713-5714-5715 is a mixture of all 3 antibodies and REGN5713-5715 is a mixture of just REGN5713 and REGN5715.  Please note that this clinical trial will use an investigational drug product. The safety and efficacy of which has not been fully evaluated by Regulatory Authorities, including Health Canada, and has no received marketing authorization in any country.

Main eligibility criteria for participation

• Healthy males and non-pregnant females
• At least 18 years of age at time of medical screening
• Allergy to birch pollen
• Additional criteria will be assessed during the telephone pre-qualification assessment and during medical screening

Study duration

The study duration is approximately 46 weeks consisting of 13 clinic visits at Cliantha Research in Mississauga and two follow up telephone calls. There is also an in-home component to answer questions about symptoms recorded in an electronic diary that will be provided to study participants.

Compensation for participation

The compensation is $10,530 CAD for completion of the study in its entirety. Participants who qualify in Visit 1 and attend Visit 2, will receive the V1 compensation amount of $150 during Visit 2.  Once enrolled and due to the length of the study, participants will be eligible to receive compensation on a prorated basis at the completion of Visit 4, Visit 8, Visit 10, and Visit 13. Final study compensation for Visit 14, Visit 15, and the completion amount will be paid within 10 business days of study completion.

How to participate

Step 1: Pass a telephone questionnaire to determine pre-qualification and registration (approximately a 20-minute call with a recruitment coordinator).

Step 2: Medical screening at the Cliantha Research clinic in Mississauga (approximately 5-6 hrs.). During this visit, the following will occur:

• You will be provided with details of the study including any procedures, tests and/or any other aspects of the study which is investigational.
• You will be able to review the informed consent form.
• You will have the chance to ask any questions you may have about the study.
• If you elect to sign the consent form, the study doctor or study staff will perform tests to determine if you meet all the requirements to participate in this study.

Participation and confidentiality

Participation in the study is entirely voluntary. You may refuse to participate, or you may discontinue your participation at any time without explanation. All information obtained during these studies will be kept strictly confidential. The research data will be available only to the research team. This study has been reviewed by Advarra IRB, an independent Research Ethics Board.

Registration

To register for the study, contact us directly at (905) 282-1808 or click on the following link, and a Cliantha team member will contact you within 24 hours: https://www.atcliantha.com/mississauga/register_to_participate.html

Registration Deadline: 26-Nov-2022

Questions

Please contact the Cliantha Recruitment Team at (905) 282-1808 and we’d be happy to answer your questions and provide more study information. Our office hours are Monday to Friday 8:30am – 6:00pm and Saturday 8:30am – 4:30pm.

Cliantha Research Clinic

4500 Dixie Road

Mississauga, ON L4W 1V7

Online study information

Clinical Trials.gov website click on this link: https://clinicaltrials.gov/ct2/show/NCT05430919?cond=NCT05430919&draw=2&rank=1

Cliantha Research volunteer website click on this link: https://www.atcliantha.com/mississauga/study_ref_no_C2D02407.html