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

Primary Purpose

Clinically Symptomatic Respiratory Illness

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dactolisib

Placebo

About this trial

This is an interventional prevention trial for Clinically Symptomatic Respiratory Illness focused on measuring Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mg daily RTB101

Placebo

Arm Description

Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks

Oral matching placebo once daily for 16 weeks

Outcomes

Primary Outcome Measures

Percentage of subjects with clinically symptomatic respiratory illness

Secondary Outcome Measures

Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s)

Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen)

Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s)

Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness

Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

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.

Full Information

NCT ID

NCT04139915

First Posted

October 17, 2019

Last Updated

November 20, 2019

Sponsor

Restorbio Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04139915

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Phase 3 trial RTB-101-204 study did not meet its primary endpoint

Study Start Date

October 21, 2019 (Actual)

Primary Completion Date

November 15, 2019 (Actual)

Study Completion Date

November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Restorbio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinically Symptomatic Respiratory Illness

Keywords

Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mg daily RTB101

Arm Type

Experimental

Arm Description

Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral matching placebo once daily for 16 weeks

Intervention Type

Drug

Intervention Name(s)

Dactolisib

Other Intervention Name(s)

RTB101, BEZ235

Intervention Description

TORC1 inhibitor

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsule

Primary Outcome Measure Information:

Title

Percentage of subjects with clinically symptomatic respiratory illness

Time Frame

Through Week 16

Secondary Outcome Measure Information:

Title

Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s)

Time Frame

Through Week 16

Title

Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen)

Time Frame

Through Week 16

Title

Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s)

Time Frame

Through Week 16

Title

Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness

Time Frame

Through Week 16

Title

Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses

Time Frame

Through Week 16

Title

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

Time Frame

Through Week 20

Title

Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses

Description

Time Frame

Through Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Restorbio Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29997249

Citation

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.

Results Reference

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

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