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The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared with placebo in adult participants with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: IRL201104 | Experimental | IRL201104 IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 |
|
| Arm 2: Placebo | Placebo Comparator | Placebo IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRL201104 | Drug | lyophilised powder for reconstitution for IV dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The mean diameter of the Intradermal Challenge (IDC) Late Phase Response (LPR) on Day 84 measured 8 hours post-challenge after 10 weeks of treatment with IRL201104 compared with placebo. | An analysis of covariance (ANCOVA) will be performed | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| The largest diameter (mm) of the IDC Early Phase Response (EPR) at 30 minutes after 10 weeks of treatment with IRL201104 compared with placebo | An analysis of covariance (ANCOVA) will be performed | Day 84 |
| Skin prick test EPR endpoint titration of Grass Soluprick after 10 weeks of treatment with IRL201104 compared with placebo. |
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Inclusion Criteria:
Male or female, 18 to 65 years old, inclusive, at time of signing the informed consent form (ICF).
Body mass index within the range 19 to 30 kg/m2.
A clinical history of grass pollen-induced allergic rhinitis for at least 2 years with peak symptoms in May, June, or July.
A clinical history of moderate to severe rhinitis symptoms interfering with usual daily activities or with sleep as defined according to the ARIA classification of rhinitis (Bousquet, Khaltaev et al 2008)
A clinical history of rhinitis for at least 2 years requiring treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
Positive skin prick test response, defined as wheal diameter greater than or equal to 5 mm, to Phleum pratense.
Positive specific IgE, defined as greater than or equal to IgE class 2 (0.7 kU/L), against Phleum pratense.
A positive response to the nasal allergen challenge with Phleum pratense, defined as an increase in TNSS greater than or equal to 5 points.
Agree to follow the contraception requirements of the trial as described in Appendix 7.
Female participants must agree to use highly effective contraception as described in Appendix 7, or must be of non-childbearing potential. A woman is considered to be of non-childbearing potential if she meets one of the following criteria:
The ability to give informed consent and comply with study procedures.
Venous access as appropriate for IV dosing, as judged by the investigator or delegate.
Exclusion Criteria:
23. Known or suspected immunosuppression, including history of invasive opportunistic infections (eg, history of or active tuberculosis, non-tuberculous mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immunocompromised status, as judged by the investigator. 24. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the volunteer. 25. Clinical contraindication to intradermal challenge (IDC), skin prick test (SPT), skin prick titration (SPT), or nasal allergen challenge (NAC), to include:
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| Name | Affiliation | Role |
|---|---|---|
| Anoshie Ratnayake, MD | Revolo Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom | ||||
| King's College London |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000714087 | IRL201104 |
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| Placebo |
| Drug |
Matching placebo for IRL201104 |
|
An analysis of covariance (ANCOVA) will be performed |
| Day 84 |
| The weighted average of the TNSS per hour following NAC after challenge on Day 1 and day 84 of treatment with IRL201104 compared with placebo. | An analysis of covariance (ANCOVA) will be performed | Day 84 |
| Percent change in peak nasal inspiratory flow (PNIF) after the NAC on day 1 and day 84 of treatment with IRL201104 compared with placebo. | An analysis of covariance (ANCOVA) will be performed | Day 84 |
| Concentration of IRL20114 levels. | IRL201104 plasma levels will be summarized for each blood sample draw timepoint | Day 56 |
| Vital Signs: Blood pressure | Summary statistics, by and across randomized treatment group | Day 84 |
| Vital Signs: Pulse rate | Summary statistics, by and across randomized treatment group | Day 84 |
| Vital Signs: oral body temperature | Summary statistics, by and across randomized treatment group | Day 84 |
| Vital Signs: respiration rate | Summary statistics, by and across randomized treatment group | Day 84 |
| Treatment Emergent Adverse Events | Summary statistics, by and across randomized treatment group | Day 84 |
| Incidence of treatment-emergent antidrug antibody (ADA) responses | Tabulated and presented as the number and percentage of participants exhibiting the response within each treatment group | Day 84 |
| Safety Laboratory: Biochemistry | Glucose, liver function tests, urea, and electrolytes will be analysed by summary statistics, by and across randomized treatment group with data from Day 1, 56 and 84. | Day 84 |
| Safety Laboratory: Haematology | Full blood count variables will be analysed by summary statistics, by and across randomized treatment group with data from Day 1, 56 and 84. | Day 84 |
| London |
| United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |