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Study of CLU-RX-PHL injection therapy for patients with moderate to severe grass pollen allergy to find the most effective and safe dose

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What is this study about?

This study focuses on treating patients with allergic rhinitis and rhinoconjunctivitis caused by grass pollen. These conditions cause symptoms like nasal congestion, runny nose, and eye irritation during grass pollen season. The study will test a medication called CLU-RX-PHL, which contains modified grass pollen extract and is given as an subcutaneous injection under the skin. This type of treatment is known as allergy immunotherapy, which helps reduce allergic reactions to specific substances.

The purpose of this study is to determine which dose level of CLU-RX-PHL works best and is best tolerated by patients. The study will compare three different strengths of CLU-RX-PHL (high, medium, and low dose) against a placebo. The treatment will be given over a period of 50 weeks.

During the study, participants will receive injections of either CLU-RX-PHL or placebo. The effectiveness of the treatment will be measured during the grass pollen season by tracking allergy symptoms and the use of additional allergy medications. Participants will need to keep track of their symptoms using an electronic diary. The study team will monitor participants’ health throughout the treatment period to ensure safety.

1 Initial treatment phase

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

The placebo solution looks, smells, and feels the same as the treatment but contains no active medication

Your assigned treatment group will be determined randomly

2 Symptom monitoring during grass pollen season

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

The monitoring will focus on both nasal symptoms (such as sneezing, runny nose) and eye symptoms

You will rate your symptoms using a simple scoring system

This monitoring will be particularly important during the peak grass pollen period

3 Quality of life assessment

You will complete questionnaires about how your allergies affect your daily life

You will use a visual scale to rate your overall discomfort from allergy symptoms

These assessments will be done both before and after treatment to measure any changes

4 Nasal provocation testing

You will undergo a nasal provocation test before and after treatment

This test involves applying grass pollen extract to your nose in increasing amounts

The test helps measure how your sensitivity to grass pollen changes with treatment

5 Follow-up evaluations

Regular check-ups will monitor your response to treatment

Your lung function will be tested if you have asthma

Blood tests will be conducted to ensure your safety throughout the study

Who Can Join the Study?

  • Patient must sign an informed consent form before any study procedures begin
  • Age must be between 18 and 65 years at the time of signing the consent form
  • Must have moderate-to-severe allergic rhinitis/rhinoconjunctivitis (allergic nose and eye symptoms) caused by grass pollen for at least 2 years. Patients can participate if they either:
    – Have well-controlled mild-to-moderate asthma, or
    – Have no asthma
  • For patients with asthma: 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 Phleum pratense (timothy grass) pollen through:
    – Positive skin prick test
    – Specific blood test showing allergy antibodies
    – History of significant allergy symptoms during grass pollen season
    – Positive nasal reaction test to grass pollen
  • Must be able to understand and follow instructions for using an electronic diary
  • Must be willing and able to complete regular electronic diary entries about symptoms and medication use
  • Must have laboratory test results within normal range or considered not medically significant if outside normal range

Who Cannot Join the Study?

  • History of severe allergic reactions (anaphylaxis) requiring emergency treatment
  • Current or past treatment with immunotherapy for grass pollen allergy within the last 5 years
  • Presence of other significant allergies that could interfere with the study results (such as severe pet or dust allergies)
  • Ongoing asthma that requires regular medication
  • Use of medications that could affect the study results, including:
    • Regular use of oral antihistamines
    • Regular use of nasal corticosteroids
    • Use of oral steroids in the past 3 months
  • Pregnancy or planning to become pregnant during the study period
  • Significant medical conditions that could affect participation, including:
    • Heart disease
    • Liver disease
    • Kidney disease
    • Autoimmune disorders
  • Current participation in other clinical trials or within the past 30 days
  • History of drug or alcohol abuse within the past 2 years
  • Any condition that could compromise the ability to follow study procedures

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 Status
Pgoijz fvs Hzp utf Anmrpveqkpfw Dbu Yvmb Yuvtj Dresden Germany
Pcizzdmgnqlc Aqgmgoidmbgu Pfdncg Dim Tflbor Gofcl Bonn Germany
Hve Pvigzw Ddvuxlm Doi mxfm Uct Syynxru Dresden Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
15.10.2025

Trial locations

Investigated drugs:

CLU-RX-PHL is an immunotherapy treatment given as an injection under the skin (subcutaneously) to treat grass pollen allergies. This medication is designed to help reduce allergic reactions by gradually exposing the patient’s immune system to grass pollen allergens. The treatment aims to decrease allergy symptoms and reduce the need for other allergy medications during grass pollen season.

Allergic Rhinitis – A condition where the immune system overreacts to allergens like grass pollen, causing inflammation of the nasal passages. The condition causes symptoms in both the nose and eyes, including sneezing, runny nose, nasal congestion, and itchy, watery eyes. The symptoms typically worsen during exposure to specific allergens, such as during grass pollen season. Allergic rhinitis can vary in severity from mild to severe, affecting daily activities and quality of life. When the eyes are also affected (rhinoconjunctivitis), patients experience additional symptoms like red, itchy, and watery eyes.

Rhinoconjunctivitis – A combination of rhinitis and conjunctivitis, affecting both the nasal passages and eyes simultaneously. The condition causes inflammation of the nasal membranes and the conjunctiva of the eyes, resulting in both nasal and ocular symptoms. The symptoms include nasal congestion, runny nose, sneezing, along with red, itchy, and watery eyes. The condition commonly occurs in response to allergens such as grass pollen. The symptoms may fluctuate in intensity depending on allergen exposure levels.

Trial ID:
2024-517521-25-00
Protocol code:
SC-3G2A
Trial Phase:
Therapeutic use (Phase IV)

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