Seasonal Allergic RhinitisPhase 2NCT05098522
Allergen Challenge Trial of IRL201104 in Seasonal Allergic Rhinitis
A Phase 2 study testing IRL201104 in people with Seasonal Allergic Rhinitis, run by Revolo Biotherapeutics at 2 sites in United Kingdom.
Trial summary
The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared with placebo in adult participants with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- IRL201104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Nov 2021to 27 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- post-menopausal (amenorrhea for at least 12 months, and follicle-stimulating hormone [FSH] tests at screening confirms post-menopausal status)
- has no uterus, ovaries or fallopian tubes. c. documentation of non-childbearing potential from a reproductive specialist.
- 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.
Who cannot join
- A prebronchodilator forced expiry volume in 1 second (FEV1) less than 70% of the predicted value at the screening baseline visit.
- Clinical history of persistent asthma requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season.
- Clinical history of moderate - severe allergic rhinitis, according to the ARIA classification, caused by a perennial allergen to which the participant is regularly exposed.
- Clinical history of moderate-severe allergic rhinitis, according to the ARIA classification, caused by tree pollen (those with mild intermittent symptoms not requiring regular treatment may be included).
- History of emergency visit or hospital admission for asthma in the previous 12 months.
- History of chronic obstructive pulmonary disease.
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- History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
- History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, ear pain, pressure, or fullness.
- History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency.
- At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
- Active malignancy at randomization.
- Any tobacco smoking within the last 6 months or a history of greater than or equal to 10 pack years.
- Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years.
- History of bleeding disorders or treatment with anticoagulation therapy.
- History of anti-IgE monoclonal antibody treatment.
- Ongoing systemic immunosuppressive treatment.
- History of intolerance to the study therapy, rescue medications, or their excipients.
- Pregnant or lactating women. For women of childbearing potential, a positive serum or urine pregnancy test.
- The use of any investigational drug within 30 days of the screening visit.
- The presence of any medical condition that the investigator deems incompatible with participation in the study.
- Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m2) or end stage renal disease.
- 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:
- Previous anaphylactic reaction to grass pollen or extract excipients
- Acute inflammation of the nose or paranasal sinuses
- Severe and uncontrolled bronchial asthma or chronic obstructive pulmonary disease
- Systemic immunotherapy
- A generalised dermatological condition rendering it impracticable to perform SPT or IDC on unaffected skin.
- Severe dermatographism
- Unable to cease antihistamines/other interfering drugs (i.e. antidepressants)
- Concomitant use of beta-blockers
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hammersmith Medicines Research
London
King's College London
London
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Allergen Challenge Trial of 6 Repeat Doses of IRL201104 in Adult Participants With Seasonal Allergic Rhinitis.
The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared with placebo in adult participants with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- IRL201104, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRL201104Drug
lyophilised powder for reconstitution for IV dosing
PlaceboDrug
Matching placebo for IRL201104
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: IRL201104 | Experimental | IRL201104 IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 Receives: Drug: IRL201104 |
| Arm 2: Placebo | Placebo comparator | Placebo IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 84
Secondary outcomes (13)
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
Measured: Day 84
Skin prick test EPR endpoint titration of Grass Soluprick after 10 weeks of treatment with IRL201104 compared with placebo.
An analysis of covariance (ANCOVA) will be performed
Measured: 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
Measured: 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
Measured: Day 84
Concentration of IRL20114 levels.
IRL201104 plasma levels will be summarized for each blood sample draw timepoint
Measured: Day 56
Vital Signs: Blood pressure
Summary statistics, by and across randomized treatment group
Measured: Day 84
Vital Signs: Pulse rate
Summary statistics, by and across randomized treatment group
Measured: Day 84
Vital Signs: oral body temperature
Summary statistics, by and across randomized treatment group
Measured: Day 84
Vital Signs: respiration rate
Summary statistics, by and across randomized treatment group
Measured: Day 84
Treatment Emergent Adverse Events
Summary statistics, by and across randomized treatment group
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start4 Nov 2021
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revolo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anoshie Ratnayake, MD, Study director, Revolo Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098522
- Sponsor's protocol ID
- RVLO 121-05
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Allergen Challenge Trial of 6 Repeat Doses of IRL201104 in Adult Participants With Seasonal Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT05098522
- Acronym / sponsor ID
- RVLO 121-05
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Revolo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared with placebo in adult participants with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: IRL201104 | Experimental | Drug: IRL201104IRL201104 IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 |
| Arm 2: Placebo | Placebo comparator | Drug: PlaceboPlacebo IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (30 listed)
- A prebronchodilator forced expiry volume in 1 second (FEV1) less than 70% of the predicted value at the screening baseline visit.
- Clinical history of persistent asthma requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season.
- Clinical history of moderate - severe allergic rhinitis, according to the ARIA classification, caused by a perennial allergen to which the participant is regularly exposed.
- Clinical history of moderate-severe allergic rhinitis, according to the ARIA classification, caused by tree pollen (those with mild intermittent symptoms not requiring regular treatment may be included).
- History of emergency visit or hospital admission for asthma in the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRL201104lyophilised powder for reconstitution for IV dosing | Drug | Arm 1: IRL201104 |
| PlaceboMatching placebo for IRL201104 | Drug | Arm 2: Placebo |
Primary outcome
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.
Time frame: Day 84
An analysis of covariance (ANCOVA) will be performed
13 secondary outcomes
The largest diameter (mm) of the IDC Early Phase Response (EPR) at 30 minutes after 10 weeks of treatment with IRL201104 compared with placebo
Time frame: Day 84
Skin prick test EPR endpoint titration of Grass Soluprick after 10 weeks of treatment with IRL201104 compared with placebo.
Time frame: 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.
Time frame: 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.
Time frame: Day 84
Concentration of IRL20114 levels.
Time frame: Day 56
Vital Signs: Blood pressure
Time frame: Day 84
Vital Signs: Pulse rate
Time frame: Day 84
Vital Signs: oral body temperature
Time frame: Day 84
Vital Signs: respiration rate
Time frame: Day 84
Treatment Emergent Adverse Events
Time frame: Day 84
Incidence of treatment-emergent antidrug antibody (ADA) responses
Time frame: Day 84
Safety Laboratory: Biochemistry
Time frame: Day 84
Safety Laboratory: Haematology
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoshie Ratnayake, MD study director
Revolo Biotherapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRL201104 in people with Seasonal Allergic Rhinitis, run by Revolo Biotherapeutics at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.