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

• ClinicalTrials.gov Identifier: NCT04139915
• Recruitment Status: Withdrawn
• First Posted: October 25, 2019
• Last Update Posted: November 22, 2019
• Sponsor: Restorbio Inc.
• Information provided by (Responsible Party): Restorbio Inc.

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Sponsors and Collaborators

Restorbio Inc.

Investigators

• Study Director: Medical Director; Restorbio Inc.

More Information

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.

• Responsible Party: Restorbio Inc.
• ClinicalTrials.gov Identifier: NCT04139915
• Other Study ID Numbers: RTB-101-205
• First Posted: October 25, 2019
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Dactolisib; Antineoplastic Agents