Study of CLU-RX-BET injection therapy for patients with moderate to severe birch pollen allergies

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What is this study about?

This study focuses on allergic rhinitis and rhinoconjunctivitis caused by birch pollen allergy. These conditions cause symptoms like nasal congestion, runny nose, and eye irritation during birch pollen season. The study will test a medication called CLU-RX-BET, which is given as an injection under the skin to treat birch pollen allergies. The purpose is to find the most effective and best-tolerated dose of this treatment.

The study will compare three different doses of CLU-RX-BET (high, medium, and low) against a placebo. The treatment will be given through subcutaneous injections, which means the medication is injected beneath the skin. The study medication contains modified birch pollen extract that has been treated with a substance called glutaraldehyde to make it safer for treatment.

During the study, participants will receive multiple injections over a period of 50 weeks. They will need to track their allergy symptoms and use of additional medications during the birch pollen season. The effectiveness of the treatment will be measured by monitoring how well it reduces allergy symptoms and the need for other allergy medications compared to the placebo treatment.

1 Initial treatment phase

You will receive subcutaneous injections (under the skin) of either CLU-RX-BET (in low, medium, or high dose) or a placebo solution

The placebo solution looks, smells, and tastes identical to the active treatment but contains no active ingredients

The treatment is specifically designed for birch pollen allergy

2 Monitoring during birch pollen season

You will need to complete an electronic diary to record your allergy symptoms and any additional medications used

The monitoring will focus on both nasal symptoms (affecting the nose) and ocular symptoms (affecting the eyes)

Your symptoms will be tracked during the peak birch pollen period and throughout the entire birch pollen season

3 Quality of life assessment

You will complete a quality of life questionnaire focused on how allergies affect your daily activities

You will rate your overall discomfort from allergies using a visual scale from 0 to 10

4 Nasal provocation testing

You will undergo a nasal provocation test where your nose’s reaction to birch pollen is measured

This test will be performed before and after the treatment period to measure any changes in your allergic response

5 Safety monitoring

Any side effects or reactions to the treatment will be recorded and monitored

Regular safety assessments will be conducted throughout the study period

Who Can Join the Study?

Must sign and date the informed consent form before any study examinations
Age must be between 18 and 65 years when signing the consent form
Must have had moderate-to-severe allergic rhinitis or rhinoconjunctivitis (allergic reactions affecting nose and eyes) caused by birch pollen for at least 2 years
If asthmatic, must have well-controlled mild-to-moderate asthma. Non-asthmatic individuals may also participate
For asthmatic patients: must have FEV1 (amount of air that can be forcefully exhaled in one second) greater than 80% of normal predicted value
Must show allergic reaction to birch pollen confirmed by:
- Positive skin prick test
- Specific blood test showing birch pollen allergy
- History of significant allergy symptoms during birch pollen season
- Positive response to nasal exposure test with birch pollen
Must be able to understand and follow instructions for using electronic diary
Must be willing and able to complete daily electronic diary entries about symptoms and medication use
Must have normal laboratory test results, or results that doctors consider not medically concerning

Who Cannot Join the Study?

History of severe allergic reactions (anaphylaxis) to any allergen
Previous treatment with immunotherapy (allergy shots or tablets) for birch pollen in the past 5 years
Current asthma that is not well controlled with medication
Presence of other significant respiratory conditions that could interfere with the study results
Ongoing treatment with medications that could affect allergy symptoms or interact with the study medication
Pregnancy or planning to become pregnant during the study period
Participation in another clinical trial within the past 30 days
History of autoimmune diseases (conditions where the immune system attacks healthy cells)
Serious medical conditions that could compromise safety during the study
Known allergies or sensitivity to any components of the study medication
Use of systemic corticosteroids (oral or injectable anti-inflammatory medications) in the past 3 months
Inability to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Psifao fzz Hto uee Agaldrvrteod Dxd Ytya Yrmhx	Dresden	Germany
Pktmsqqtfbat Aypubtrjxsok Pjuxyf Dmh Tbzjma Grcvd	Bonn	Germany
Hxm Pzzzji Dkzqbrs Dng mozz Uhn Scoukyw	Dresden	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.07.2025

Trial locations

CLU-RX-BET is an immunotherapy treatment designed to help patients who are allergic to birch pollen. It is administered under the skin (subcutaneously) and works by gradually exposing the patient to small amounts of birch pollen allergens. This helps the immune system become less sensitive to birch pollen, potentially reducing allergic symptoms and the need for other allergy medications. This type of treatment is known as cluster immunotherapy, which means that multiple doses are given in a clustered schedule to build up tolerance more quickly than traditional immunotherapy.

Allergic rhinitis – A condition where the immune system reacts to airborne substances like pollen, causing inflammation of the nasal passages. The condition causes symptoms such as sneezing, runny nose, nasal congestion, and itchy nose, often accompanied by eye symptoms like watery and itchy eyes. Allergic rhinitis can be seasonal (triggered by specific pollen seasons) or perennial (occurring year-round). When birch pollen triggers the condition, symptoms typically appear during the birch pollination period in spring.

Allergic rhinoconjunctivitis – A combination of allergic reactions affecting both the nasal passages and eyes. The condition occurs when allergens like pollen trigger an immune response, causing inflammation of the nasal mucosa and conjunctiva (the membrane covering the eye). Symptoms include nasal congestion, sneezing, and runny nose, along with red, itchy, and watery eyes. The condition commonly occurs during specific pollen seasons, with birch pollen being a frequent trigger in spring.

Trial ID:

2024-517515-75-00

Protocol code:

SC-3F2A

Trial Phase:

Therapeutic use (Phase IV)

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Study of CLU-RX-BET injection therapy for patients with moderate to severe birch pollen allergies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?