Authorised Therapeutic confirmatory (Phase III) Seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure

Long-term clinical trial of PQ Grass in paediatric subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen

EU CTIS ID: 2023-508520-36-00

What this study is testing

-Part A: To evaluate the efficacy of PQ Grass 27600 SU in paediatric subjects with grass pollen induced SAR. -Part B: To evaluate the sustained long-term efficacy of PQ Grass 27600 SU in paediatric subjects.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Written informed consent from a legal representative on the subject’s behalf (with/without assent depending on applicable country-specific regulations).
10. Forced expiratory volume in 1 second (FEV1) ≥80% of predicted and FEV1/forced vital capacity (FVC) ≥75% or, if adequate spirometry cannot be performed, PEFR ≥75% predicted at screening and randomisation visit.
11. Be able to adhere to dose and visit schedule
2. Subjects aged 4 to 16 years inclusive at the time of signing the consent (assent) form. The subject must be ≥5 to ≤16 years old at the first randomisation visit.
3. Male or female.
4. Female subjects are allowed to participate in the trial if: i. Not of childbearing potential (defined as premenarche). ii. Of childbearing potential with a negative urine pregnancy test at all visits and, if sexually active, agree to use 1 highly effective method of contraception, during the whole duration of the trial, starting at least 7 days before first dose administration and for at least 30 days after the last dose of IMP/placebo or after next menstruation, whichever is longer.

You likely can't join if

1. Pregnant or lactating subject.
10. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
11. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
12. Severe eczema with involvement of more than 25% of the body surface.
13. Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the Investigator.
14. Any acute infection (including upper respiratory tract infections in the 7 days prior to Visit 2, which in the opinion of the investigator may pose a safety risk to the subject.

See the full eligibility criteria

Who can join

1. Written informed consent from a legal representative on the subject’s behalf (with/without assent depending on applicable country-specific regulations).
10. Forced expiratory volume in 1 second (FEV1) ≥80% of predicted and FEV1/forced vital capacity (FVC) ≥75% or, if adequate spirometry cannot be performed, PEFR ≥75% predicted at screening and randomisation visit.
11. Be able to adhere to dose and visit schedule
2. Subjects aged 4 to 16 years inclusive at the time of signing the consent (assent) form. The subject must be ≥5 to ≤16 years old at the first randomisation visit.
3. Male or female.
4. Female subjects are allowed to participate in the trial if: i. Not of childbearing potential (defined as premenarche). ii. Of childbearing potential with a negative urine pregnancy test at all visits and, if sexually active, agree to use 1 highly effective method of contraception, during the whole duration of the trial, starting at least 7 days before first dose administration and for at least 30 days after the last dose of IMP/placebo or after next menstruation, whichever is longer.
5. Good general health, as determined by the Investigator based on a medical evaluation including medical history, physical examination and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the trial procedures.
6. Positive history of moderate to severe SAR ascribed to grass (Pooideae) pollen exposure, of at least one year duration or by the 5th birthday (for children of 5-6 years old), with moderate to severe SAR symptoms despite having received allergy pharmacotherapy.
7. A positive skin prick test (SPT) to grass pollen (wheals [longest diameter] ≥ 3 mm and histamine ≥ 3 mm) and a negative SPT to the negative control (wheal diameter = 0 mm) at screening.
8. Grass specific IgE class ≥2 as documented by an immunoCAP test at screening. (Please note: Class ≥2 by an ImmunoCAP test implies grass specific IgE ≥0.71 kUA/L)
9. Children who are able to perform spirometry or peak flow measurements.

What rules you out

1. Pregnant or lactating subject.
10. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
11. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
12. Severe eczema with involvement of more than 25% of the body surface.
13. Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the Investigator.
14. Any acute infection (including upper respiratory tract infections in the 7 days prior to Visit 2, which in the opinion of the investigator may pose a safety risk to the subject.
15. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis
16. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the trial medication.
17. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
18. History of any previous allergen immunotherapy, by any route.
19. Unable to meet medication washout requirements listed in the table prohibited medications.
2. Presence of any medical history of moderate to severe allergy symptoms, to any other seasonal allergen (other than grass) or perennial allergens, confirmed by a positive specific IgE [Class ≥2] at screening.
20. Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the Investigator.
21. Monoamine oxidase inhibitor medication and tricyclic antidepressants.
22. Β-blocker medication for any indication.
23. Any previous therapy (within the previous 5 years) or current therapy with anti-IgE (e.g., Xolair), anti-interleukins (ILs) (e.g., mepolizumab) or any other therapy with a biologic agent.
24. All vaccinations (including influenza and coronavirus disease 2019 [COVID-19] vaccines, and treatment with a preparation containing MPL [e.g., Cervarix, Fendrix]) administered 30 days or less prior to randomisation or any planned vaccinations during the treatment periods. Influenza and other vaccinations should also be avoided for 30 days after the last injection of every treatment period. Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time.
25. Participation in a clinical trial research trial with any IMP within 4 weeks from screening.
26. Known fear of injections that in the opinion of the Investigator, may impact adherence to the dosing schedule and cooperation with required clinical trial procedures.
27. Clinical history of drug or alcohol abuse which, in the Investigator’s opinion, could interfere with the subject’s ability to participate in the trial.
28. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the trial site, Sponsor, Sponsor’s representative, or another individual who has access to the clinical trial protocol.
29. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution, except children in long-term foster care, at the discretion of the Investigator.
3. Moderate to severe symptoms during the 2 years prior to screening to a perennial or seasonal allergen not tested by IgE (for Exclusion Criterion #2), that cannot be avoided during the trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected, as determined by the Investigator.
4. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
5. History of any autoimmune disease or other immunological disorder or other diseases (including, but not limited to malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, psychiatric, endocrine or pulmonary disease) that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the trial treatment.
6. Presence of severe or poorly controlled asthma as defined by current Global Initiative for Asthma (GINA) guidelines (current GINA) or requiring more than a daily dose above 800 μg (in adolescents) or 400 μg (in children) of inhaled budesonide [or equivalent inhaled corticosteroid].
7. Hospital admission for exacerbation of asthma in the 12 months prior to Visit 1 or any history of a life-threatening asthma attack.
8. Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
9. Presence of nasal polyps and/or chronic sinusitis.

The study team makes the final eligibility decision.

Where it's taking place

United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.