Efficacy and Safety Evaluation of Lebrikizumab and Mometasone Furoate in Adult Patients with Perennial Allergic Rhinitis: A Phase 3 Randomized Controlled Trial

The primary objective of this Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study is to evaluate the **efficacy** of lebrikizumab up to Week 16 on total nasal symptoms in adult participants with **Perennial Allergic Rhinitis** (PAR) compared with placebo. This objective is clinically relevant as it aims to determine the potential of lebrikizumab to alleviate the persistent nasal symptoms associated with PAR, which can significantly impact the quality of life of affected individuals.

The clinical trial involves a total of **260 participants** diagnosed with **Perennial Allergic Rhinitis (PAR)**. The study population includes both male and female subjects, with an age range that encompasses adolescents and adults. Participants were selected based on specific criteria, including a physician-diagnosed PAR and a positive skin prick test or antigen-specific serum immunoglobulin E (IgE) for indoor allergens. Individuals with concomitant asthma are included, provided their condition has been stable for at least three months prior to screening. The trial also considers dermatographic participants with a history of dermatographism. The study population is characterized by a diverse group, including vulnerable populations, ensuring a comprehensive evaluation of the treatment's efficacy. Lifestyle factors such as diet and physical activity were not specified as part of the selection criteria.

The clinical trial is a **Phase 3**, multicenter, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of **lebrikizumab** in adult participants with **perennial allergic rhinitis**. The trial aims to assess the efficacy of lebrikizumab up to Week 16 on total nasal symptoms compared with placebo. The study is expected to commence recruitment on September 20, 2024, and conclude by August 3, 2026. Participants will be randomly assigned to receive either lebrikizumab, administered as a subcutaneous injection, or a placebo. The trial will also involve the use of **mometasone furoate** as an auxiliary medication, administered via nasal spray.

The trial will include several study visits, beginning with a screening visit to confirm eligibility based on criteria such as a physician-diagnosed perennial allergic rhinitis and a positive skin prick test or antigen-specific serum immunoglobulin E for indoor allergens. Participants with stable asthma may also be included. Following the screening, participants will undergo regular follow-up visits to monitor their response to the treatment and any adverse effects. The primary endpoint is the mean change from baseline in the Total Nasal Symptom Score at Week 16, which is a composite score of symptoms including rhinorrhea, nasal congestion, nasal itching, and sneezing.

The expected duration of participant involvement in the trial is approximately 16 weeks, with the possibility of early termination if significant adverse effects occur or if the participant withdraws consent. The trial is not classified as low intervention, and it is conducted under strict regulatory guidelines to ensure participant safety and data integrity. The study is structured to maintain blinding and control, with neither participants nor investigators aware of the treatment assignments until the study's conclusion.

The clinical trial involves the administration of **Lebrikizumab**, a monoclonal antibody, as the primary investigational product. **Lebrikizumab** is provided in a **solution for injection** form and is administered via **subcutaneous injection**. The pharmaceutical form is a pre-filled syringe with a needle safety device. The dosing schedule and frequency of administration are determined by the study protocol, with the maximum treatment period set at one week. Participant compliance is monitored through regular assessments and documentation of dosing adherence.

In addition to **Lebrikizumab**, the trial includes a **placebo** comparator, which is designed to match the investigational product in appearance but contains no active substance. The placebo is used to maintain the double-blind nature of the study, ensuring unbiased assessment of the investigational product's efficacy and safety. The placebo is administered in the same manner as **Lebrikizumab**, using a similar pre-filled syringe device.

**Mometasone furoate** is utilized as an auxiliary treatment in the trial. It is a **nasal spray** formulation, classified under the ATC code **R01AD09**. The **mometasone furoate** is centrally supplied, re-labeled, repackaged, and released by a qualified person (QP) for use in the study. Although the packaging and labeling are modified, the product is used according to its market authorization. The administration of **mometasone furoate** is conducted as per the study protocol, with compliance monitored through participant logs and periodic checks.

The efficacy of **lebrikizumab** in the treatment of perennial allergic rhinitis will be assessed in a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study. The primary endpoint for evaluating efficacy is the mean change from baseline in the Total Nasal Symptom Score (TNSS) at Week 16. The TNSS is a composite score of four symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale from 0 (none) to 3 (severe), resulting in a total score range of 0 to 12, with higher scores indicating more severe symptoms. Efficacy assessments will be conducted at baseline and at Week 16 to determine the change in TNSS.