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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Clinically Symptomatic Respiratory Illness
• Intervention / Treatment: Drug: Placebo; Drug: Dactolisib

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg daily RTB101; Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks	Drug: Dactolisib; TORC1 inhibitor; Other Names: BEZ235; RTB101
Placebo Comparator: Placebo; Oral matching placebo once daily for 16 weeks	Drug: Placebo; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Restorbio Inc.
• Investigators: Study Director: Medical Director, Restorbio Inc.

Publications and helpful links

General Publications

• Mannick JB, Morris M, Hockey HP, Roma G, Beibel M, Kulmatycki K, Watkins M, Shavlakadze T, Zhou W, Quinn D, Glass DJ, Klickstein LB. TORC1 inhibition enhances immune function and reduces infections in the elderly. Sci Transl Med. 2018 Jul 11;10(449):eaaq1564. doi: 10.1126/scitranslmed.aaq1564.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pneumonia; Influenza; Immunosenescence; Virus; Respiratory Tract Infections; Mechanistic Target of Rapamycin (mTOR)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Antineoplastic Agents; Dactolisib
• Other Study ID Numbers: RTB-101-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No