Study on the Effectiveness of Cup a 1 Immunotherapy for Patients with Moderate to Severe Allergic Rhinoconjunctivitis with or without Controlled Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with allergic rhinoconjunctivitis, which is an allergic reaction that affects the nose and eyes, and may also include patients with controlled asthma. The treatment being tested is an immunotherapy using a purified protein called Cup a 1, which is derived from the pollen of the Cupressus arizonica tree, commonly known as Arizona cypress. This study aims to evaluate the effectiveness and safety of this treatment in reducing allergy symptoms in patients who are sensitive to Cupressaceae pollen.

Participants in the study will be randomly assigned to receive either the Cup a 1 treatment or a placebo, which is a substance with no active therapeutic effect. Neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, ensuring that the results are unbiased. The treatment will be administered as a suspension for injection under the skin, known as subcutaneous use. The study will take place over two pollen seasons, during which participants will complete questionnaires to report the frequency and severity of their symptoms.

The primary goal of the study is to assess how well the Cup a 1 treatment works in reducing allergy symptoms compared to the placebo. This will be measured by a combination of symptom scores and medication use. Secondary goals include evaluating the number of symptom-free and medication-free days, as well as any additional doctor visits or emergencies related to the allergies. The study will also monitor any side effects and changes in specific immune markers in the participants. The trial is expected to continue until March 2025.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a skin test to check for sensitivity to Cupressaceae pollen and Cup a 1 protein.

A blood test is performed to measure specific IgE levels, which should be 2 kU/l or higher.

2 randomization

Participants are randomly assigned to receive either the treatment or a placebo. Neither the participants nor the researchers know which group each participant is in.

3 treatment administration

The treatment involves subcutaneous injections of the purified protein Cup a 1 or a placebo. The placebo consists of a saline solution with mannitol and histamine.

Injections are administered at regular intervals as specified in the study protocol.

4 monitoring and follow-up

Participants are monitored for symptom frequency and severity. This includes completing a questionnaire during two successive pollen seasons.

Regular follow-up visits are scheduled to assess the control of asthma and allergic rhinitis, using tools like the ACT and modified ARIA.

5 evaluation of outcomes

The primary outcome is the efficacy of the treatment, evaluated through symptom scores and the Combined Symptom and Medication Score (CSMS).

Secondary outcomes include the frequency of symptom-free days, medication-free days, and any adverse events.

6 end of trial

The trial is expected to conclude by March 31, 2025. Final assessments will be conducted to evaluate the overall efficacy and safety of the treatment.

Who Can Join the Study?

Must be a male or female between the ages of 12 and 65.
Must provide informed consent to participate in the study. If the participant is a minor, consent must also be obtained from legal guardians or representatives.
Must have moderate or severe allergic rhinitis (inflammation of the nose due to allergies) or rhinoconjunctivitis (inflammation of the nose and eyes due to allergies), with or without controlled asthma, and must be sensitized to Cupresaceae (a type of plant family).
Must have IgE levels (a type of antibody related to allergies) for Cupressus or Cup a 1 that are 2 kU/l or higher, which corresponds to classes 3 to 6.
Must have a positive skin prick test (a test where a small amount of allergen is placed on the skin to see if there is a reaction) with a diameter of 3 mm or more for Diater extract of Cupressaceae arizónica and Cup a 1, conducted at the initial visit.
Must have clinically relevant symptoms when exposed to Cupresaceae.
Must be willing to follow all study requirements and be available for follow-up throughout the trial.
For women who can become pregnant, a negative urine pregnancy test is required, and they must agree to use effective birth control from 14 days before the first dose until 30 days after the last dose. This applies to women from the start of menstruation to postmenopause, unless they have been sterilized through procedures like hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), and bilateral oophorectomy (removal of both ovaries).

Who Cannot Join the Study?

Patients who have a severe allergic reaction to the treatment being studied.
Patients with a history of severe asthma that is not well controlled.
Patients who are pregnant or breastfeeding.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have received another investigational drug within the last 30 days.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Universitario San Juan De Alicante	Sant Joan D'alacant	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Fidnyrceu Pyel Lb Iywxboxhfxkbd Bcptfuowa Dnf Hhtdwhda Uqwkkfawnajpg Lb Pav	Madrid	Spain
Hrahapsb Unvafwsctqqge dul Hrnzdyk	Coslada (Madrid)	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	16.05.2022

Trial locations

Cup a 1 is a purified and isolated protein used in immunotherapy. It is administered through injections under the skin. This therapy is designed for patients who have moderate to severe allergic reactions, specifically allergic rhino conjunctivitis, which may or may not be accompanied by controlled asthma. The goal of this treatment is to help the body build a tolerance to the allergen, which in this case is related to the Cupressaceae family of plants.

Allergic rhinoconjunctivitis – This condition is characterized by inflammation of the nasal passages and eyes due to an allergic reaction. It typically occurs when the immune system overreacts to allergens such as pollen, dust, or pet dander. Symptoms include sneezing, runny or stuffy nose, itchy eyes, and watery eyes. The condition often follows a seasonal pattern, especially during pollen seasons. Over time, symptoms may vary in intensity and can be influenced by exposure to specific allergens. It is a common condition and can affect individuals of all ages.

Trial ID:

2024-519527-14-00

Protocol code:

DIA-EC-Cupa1-01-22

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Cup a 1 Immunotherapy for Patients with Moderate to Severe Allergic Rhinoconjunctivitis with or without Controlled Asthma

What is this study about?

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Who Cannot Join the Study?