Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139915
Recruitment Status : Withdrawn (Phase 3 trial RTB-101-204 study did not meet its primary endpoint)
First Posted : October 25, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Restorbio Inc.

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.

Condition or disease Intervention/treatment Phase
Clinically Symptomatic Respiratory Illness Drug: Dactolisib Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Actual Study Start Date : October 21, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

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:
  • RTB101
  • BEZ235

Placebo Comparator: Placebo
Oral matching placebo once daily for 16 weeks
Drug: Placebo
Placebo capsule




Primary Outcome Measures :
  1. Percentage of subjects with clinically symptomatic respiratory illness [ Time Frame: Through Week 16 ]

Secondary Outcome Measures :
  1. Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s) [ Time Frame: Through Week 16 ]
  2. Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) [ Time Frame: Through Week 16 ]
  3. Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s) [ Time Frame: Through Week 16 ]
  4. Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness [ Time Frame: Through Week 16 ]
  5. Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses [ Time Frame: Through Week 16 ]
  6. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Through Week 20 ]
  7. Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses [ Time Frame: Through Week 16 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139915


Sponsors and Collaborators
Restorbio Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Restorbio Inc.

Publications:
Layout table for additonal information
Responsible Party: Restorbio Inc.
ClinicalTrials.gov Identifier: NCT04139915    
Other Study ID Numbers: RTB-101-205
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Restorbio Inc.:
Mechanistic Target of Rapamycin (mTOR)
Influenza
Virus
Pneumonia
Immunosenescence
Respiratory Tract Infections
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Dactolisib
Antineoplastic Agents