Allergen Challenge Trial of IRL201104 in Seasonal Allergic Rhinitis

NCT05098522 | Completed Phase 2

• 1 other identifier: RVLO 121-05
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

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

  Day 84

• Skin prick test EPR endpoint titration of Grass Soluprick after 10 weeks of treatment with IRL201104 compared with placebo.

  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.

  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.

  Day 84

• Concentration of IRL20114 levels.

  Day 56

Study Arms (2)

Arm 1: IRL201104

EXPERIMENTAL

IRL201104 IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70

Drug: IRL201104

Arm 2: Placebo

PLACEBO COMPARATOR

Placebo IV on Day 1, Day 14, Day 28, Day 42, Day 56, Day 70

Drug: Placebo

Interventions

IRL201104 DRUG

lyophilised powder for reconstitution for IV dosing

Arm 1: IRL201104

Placebo DRUG

Matching placebo for IRL201104

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Revolo Biotherapeutics: lead

Study Sites (2)

Hammersmith Medicines Research

London, United Kingdom

Location

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

IRL201104

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anoshie Ratnayake, MD

  Revolo Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 28, 2021
• Study Start: November 4, 2021
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

GB (2)