APG777 for Asthma
Recruiting at 9 trial locations
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Apogee Therapeutics, Inc.
Must be taking: Short-acting beta-agonists, Inhaled corticosteroids
Trial Summary
What is the purpose of this trial?
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma. The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that your asthma medications like inhaled corticosteroids or leukotriene receptor antagonists be stable for a certain period before starting the trial.
What data supports the effectiveness of the drug APG777 for asthma?
Eligibility Criteria
Adults with mild-to-moderate asthma are eligible for this study. Specific details about who can join or reasons why someone might be excluded were not provided, so interested individuals should contact the trial organizers for full eligibility criteria.Inclusion Criteria
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
Asthma Control Test (ACT) score > 19 at Screening
Women of childbearing potential and male participants to use a highly effective form of contraception
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Exclusion Criteria
Known history of illicit drug abuse, harmful alcohol use
I have used biologic medications for asthma.
I currently smoke or have smoked a lot in the past.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either APG777 or placebo as per protocol
48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- APG777
Trial OverviewThe trial is testing APG777 against a placebo to assess its safety and how it's processed by the body (pharmacokinetics) in adults with asthma. Participants will be randomly assigned to either the drug or placebo group and won't know which they're receiving (double-blind).
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APG777Experimental Treatment1 Intervention
Participants will receive protocol specified dose of APG7777
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo
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Who Is Running the Clinical Trial?
Apogee Therapeutics, Inc.
Lead Sponsor
Trials
1
Recruited
390+
Findings from Research
In the phase 2b PATHWAY study involving 550 adults with severe, uncontrolled asthma, tezepelumab significantly reduced asthma exacerbations by up to 71% and improved lung function and quality of life compared to placebo.
Tezepelumab treatment led to higher rates of patient-reported outcomes, with up to 82% of patients showing improved asthma control and quality of life, indicating its effectiveness in managing severe asthma symptoms.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY.Corren, J., Garcia Gil, E., Griffiths, JM., et al.[2021]
The study of CAT-354, a human anti-IL-13 antibody, involved 23 adults with asthma and demonstrated a linear pharmacokinetic profile, with a half-life of 12-17 days and low clearance, indicating it can be safely administered in multiple doses.
Most adverse events were mild to moderate and unrelated to the medication, suggesting that CAT-354 has an acceptable safety profile for treating asthma.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma.Singh, D., Kane, B., Molfino, NA., et al.[2021]
References
Understanding the Updates in the Asthma Guidelines. [2022]
Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. [2021]
Impact of asthma control on sleep, attendance at work, normal activities, and disease burden. [2015]
Adding salmeterol to an inhaled corticosteroid reduces allergen-induced serum IL-5 and peripheral blood eosinophils. [2015]
A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. [2021]
The genetics of asthma and the promise of genomics-guided drug target discovery. [2020]
Lung Function in African American Children with Asthma Is Associated with Novel Regulatory Variants of the KIT Ligand KITLG/SCF and Gene-By-Air-Pollution Interaction. [2023]
Single-base editing of rs12603332 on chromosome 17q21 with a cytosine base editor regulates ORMDL3 and ATF6α expression. [2023]
Autophagy related gene 5 polymorphism rs17587319 (C/G) in asthmatic patients in North Indian population. [2023]
Paucigranulocytic asthma: Uncoupling of airway obstruction from inflammation. [2020]
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