Clinical trial NCT06920901: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Mild to moderate asthma
Tolerability
Immunogenicity
Pharmacokinetics
Lead sponsor: Apogee Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 52 weeks
measure: Number of Participants with Abnormal Laboratory Findings
timeFrame: Up to 52 weeks
measure: Number of Participants with Abnormal Vital Signs
timeFrame: Up to 52 weeks
measure: Number of Participants with Abnormal Electrocardiograms (ECGs)
timeFrame: Up to 52 weeks
measure: Number of Participants with Abnormal Physical Examination Findings
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Maximum concentration (Cmax) of APG777
timeFrame: Up to 48 weeks
measure: Time to reach Cmax (tmax)
timeFrame: Up to 48 weeks
measure: Terminal elimination rate constant (λz)
timeFrame: Up to 48 weeks
measure: Terminal Elimination half-life (t1/2)
timeFrame: Up to 48 weeks
measure: Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)
timeFrame: Up to 48 weeks
measure: AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: Up to 48 weeks
measure: Apparent Clearance of APG777 (CL/F)
timeFrame: Up to 48 weeks
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Up to 48 weeks
measure: Number of Participants with Anti-Drug-Antibodies (ADAs)
timeFrame: Up to 48 weeks
measure: Cmax in Participants With and without ADAs
timeFrame: Up to 48 weeks
measure: AUClast Participants With and without ADAs
timeFrame: Up to 48 weeks
measure: AUCInf Participants With and without ADAs
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Orso Health
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
city: Torrance
country: United States
facility: Orso Health
state: California
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas School of Medicine
state: Missouri
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: West Yorkshire
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit Ltd
Study officials:
References: