Clinical trial NCT04139915: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Clinically Symptomatic Respiratory Illness
Keywords: Mechanistic Target of Rapamycin (mTOR)
Influenza
Virus
Pneumonia
Immunosenescence
Respiratory Tract Infections
Lead sponsor: Restorbio Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Percentage of subjects with clinically symptomatic respiratory illness
timeFrame: Through Week 16
Secondary outcomes:
measure: Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s)
timeFrame: Through Week 16
measure: Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen)
timeFrame: Through Week 16
measure: Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s)
timeFrame: Through Week 16
measure: Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness
timeFrame: Through Week 16
measure: Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses
timeFrame: Through Week 16
measure: Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
timeFrame: Through Week 20
measure: Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses
timeFrame: Through Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Restorbio Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
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.