Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly

Study Overview
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Brief Summary
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The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.

Detailed Description
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RTB-101-205 is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, Phase 3 study to determine if RTB101, a selective TORC1 inhibitor, prevents illness associated with respiratory tract infections (defined as clinically symptomatic respiratory illness) in adults ≥65 years of age. This trial is being conducted in follow up to two Phase 2 trials in older adults in which RTB101 10 mg administered once daily for up to 16 weeks during winter cold and flu season was observed to reduce the incidence of respiratory illness associated with respiratory tract infections.

Official Title
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A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly

Conditions
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Clinically Symptomatic Respiratory Illness

Intervention / Treatment
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* Drug: Dactolisib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be ≥65 years of age Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period Exclusion Criteria: Subjects who are current smokers, stopped smoking ≤ 1 year prior to screening, or have and a ≥ 10 pack year smoking history Subjects with a medical history of clinically significant lung diseases (including COPD) other than asthma Subjects with current evidence of a serious and/or unstable medical disorder Subjects with unstable cardiac conditions Subjects with a history of systemic autoimmune diseases Subjects with Type I diabetes mellitus Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result Infection with Hepatitis B (HBV) or Hepatitis C (HCV)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg daily RTB101<br>Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks | Drug: Dactolisib<br>* TORC1 inhibitor<br>* Other names: BEZ235;|
| Placebo Comparator: Placebo<br>Oral matching placebo once daily for 16 weeks | Drug: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with clinically symptomatic respiratory illness |  | Through Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s) |  | Through Week 16 | 
| Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) |  | Through Week 16 | 
| Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s) |  | Through Week 16 | 
| Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness |  | Through Week 16 | 
| Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses |  | Through Week 16 | 
| Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 |  | Through Week 20 | 
| Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses | Descriptive statistics will be provided for the rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses. No formal statistical tests will be conducted. | Through Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections