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

NCT04139915 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: RTB-101-205
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinically Symptomatic Respiratory Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with clinically symptomatic respiratory illness

  Through Week 16

Secondary Outcomes (7)

• 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

Study Arms (2)

10 mg daily RTB101

EXPERIMENTAL

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

Drug: Dactolisib

Placebo

PLACEBO COMPARATOR

Oral matching placebo once daily for 16 weeks

Drug: Placebo

Interventions

Dactolisib DRUG

TORC1 inhibitor

Also known as: RTB101, BEZ235

10 mg daily RTB101

Placebo DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Restorbio Inc.: lead

Related Publications (1)

• 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.

  PMID: 29997249 BACKGROUND

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies; Influenza, Human; Virus Diseases; Pneumonia; Respiratory Tract Infections

Interventions

dactolisib

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Medical Director

  Restorbio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 25, 2019
• Study Start: October 21, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share