Evaluating a new treatment for adults with asthma
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
This study is testing a new asthma treatment called APG777 to see if it helps adults with mild-to-moderate asthma feel better over a year.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Apogee Therapeutics, Inc. Industry-sponsored |
| Locations | 11 sites (La Jolla, California and 10 other locations) |
| Trial ID | NCT06920901 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, and immunogenicity of APG777 in adults diagnosed with mild-to-moderate asthma. Participants will undergo a screening period followed by a treatment period lasting approximately 52 weeks, during which they will receive either the investigational drug or a placebo. The study will monitor various health outcomes to determine the effectiveness and safety of APG777 in managing asthma symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of mild-to-moderate asthma who have maintained specific asthma control measures.
Not a fit: Patients who have experienced recent asthma exacerbations requiring systemic corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for adults with asthma, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise in evaluating new asthma treatments, but the specific approach of APG777 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening * Maintain FeNO-high (≥ 25 parts per billion \[ppb\]) or FeNO-low (\< 25 ppb) status from Screening to Day 1 prior to Randomization * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening * Asthma Control Test (ACT) score \> 19 at Screening * Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1 * Women of childbearing potential and male participants to use a highly effective form of contraception Exclusion Criteria: * Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening * Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia * History of biologics use for treatment or control of asthma * Current smokers or participants with a smoking history of ≥ 10 pack years * Known history of illicit drug abuse, harmful alcohol use Note: Other protocol defined criteria may apply.
Where this trial is running
La Jolla, California and 10 other locations
- Orso Health — La Jolla, California, United States (Recruiting)
- Allergy and Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States (Recruiting)
- Orso Health — Torrance, California, United States (Recruiting)
- Sneeze, Wheeze & Itch Associates — Normal, Illinois, United States (Not_yet_recruiting)
- University of Kansas School of Medicine — Kansas City, Missouri, United States (Recruiting)
- Rochester Regional Health — Rochester, New York, United States (Not_yet_recruiting)
- OK Clinical Research, LLC — Edmond, Oklahoma, United States (Recruiting)
- Temple University — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- Bradford Teaching Hospitals NHS Foundation Trust — Bradford, West Yorkshire, United Kingdom (Not_yet_recruiting)
- Medicines Evaluation Unit Ltd — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Study Director
- Email: ClinicalTrials@apogeetherapeutics.com
- Phone: 7812082408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.