seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Sponsors
Allergy Therapeutics (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent 2. Subject who has signed and dated the ICF. 3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF. 4. Male or female. 5. Female subjects who are not of childbearing potential or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol 6. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass pollen. For Detailed list see the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating subject. 2. Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass). 3. Subjects with a positive SPT at US sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure. 4. Moderate to severe symptoms during the 3 years prior to Visit 1 to another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and/or impact the data collected, as determined by the investigator. 5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction. 6. History of autoimmune disease including Hashimoto’s thyroiditis or other immunological disorder or other diseases that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment. 7. Presence of severe or uncontrolled or partly controlled Asthma. 8. History of any allergen SIT. For Detailed List see the Protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of PQ Grass 27600 SU in grass pollen-induced seasonal allergic rhinitis and/or rhinoconjunctivitis in a field setting;Secondary Objective: To explore the treatment effect of PQ Grass on the CSMS and TCS over the GPS To explore the treatment effect of PQ Grass on the dSS and dMS components of the CSMS over the GPS To explore the treatment effect of PQ Grass on the dSS and dMS components of the TCS over the GPS To explore the relationship between TSS during CPT and CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the GPS compared to baseline To evaluate well days and severe days during the GPS To evaluate TSS during CPT at the same dose eliciting a positive response at baseline To evaluate immunological parameters To evaluate the quality of life To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced seasonal allergic rhinitis and/or rhinoconjunctivitis;Primary end point(s): The CSMS averaged over the peak grass pollen season (GPS);Timepoint(s) of evaluation of this end point: daily during the GPS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CSMS averaged over the entire (or truncated) GPS TCS averaged over the peak GPS TCS averaged over the entire (or truncated) GPS dSS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS dMS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS dSS component of the TCS averaged over the peak GPS and entire (or truncated) GPS dMS component of the TCS averaged over the peak GPS and entire (or truncated) GPS TSS during CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the peak and entire (or truncated) GPS for subjects with a positive CPT at baseline The probability of well days and severe days during the peak and entire (or truncated) GPS Pre-GPS (Visit 12) TSS measured during CPT Serum Ig responses (total IgE; grass-specific IgE and IgG4; specific IgE/total IgE and specific IgE/specific IgG4) at Visit 12 and Visit 15 Rhinoconjunctivitis quality of life questionnaire with standardised activities (RQLQ(S)) measured within the GPS Frequency, severity and relationship of AEs to treatment Frequency of AEs leading to premature discontinuation from treatment or study Frequency of AESI Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening and Visit 15 Changes in vital signs (all subjects) and PEFR (only in subjects with past or current asthma) at all treatment visits;Timepoint(s) of evaluation of this end point: daily / during the GPS / during the course of the study as indicated in the protocol | — |
Countries
Germany, United States
Contacts
Public ContactClinical Research Management
Bencard Allergie GmbH
Outcome results
None listed