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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Recruitment Status : Withdrawn (Phase 3 trial RTB-101-204 study did not meet its primary endpoint)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.

Tracking Information
First Submitted Date  ICMJE October 17, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE October 21, 2019
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
Percentage of subjects with clinically symptomatic respiratory illness [ Time Frame: Through Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s) [ Time Frame: Through Week 16 ]
  • Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) [ Time Frame: Through Week 16 ]
  • Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s) [ Time Frame: Through Week 16 ]
  • Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness [ Time Frame: Through Week 16 ]
  • Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses [ Time Frame: Through Week 16 ]
  • Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Through Week 20 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly
Official Title  ICMJE A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clinically Symptomatic Respiratory Illness
Intervention  ICMJE
  • Drug: Dactolisib
    TORC1 inhibitor
    Other Names:
    • RTB101
    • BEZ235
  • Drug: Placebo
    Placebo capsule
Study Arms  ICMJE
  • Experimental: 10 mg daily RTB101
    Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks
    Intervention: Drug: Dactolisib
  • Placebo Comparator: Placebo
    Oral matching placebo once daily for 16 weeks
    Intervention: Drug: Placebo
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). pii: eaaq1564. doi: 10.1126/scitranslmed.aaq1564.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 20, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
1534
Actual Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Germany,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT04139915
Other Study ID Numbers  ICMJE RTB-101-205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Restorbio Inc.
Study Sponsor  ICMJE Restorbio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Restorbio Inc.
PRS Account Restorbio Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP