Clinically Symptomatic Respiratory IllnessPhase 3NCT04139915
Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly
A Phase 3 study testing Dactolisib in people with Clinically Symptomatic Respiratory Illness, run by Restorbio Inc..
Trial summary
The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Clinically Symptomatic Respiratory Illness
- What is being tested?
- Dactolisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2019to 15 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.
Read the 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.
- Being tested
- Dactolisib, Placebo
- Keywords
- Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Influenza, Human, Virus Diseases, Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DactolisibDrug
Also called RTB101, BEZ235
TORC1 inhibitor
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 10 mg daily RTB101 | Experimental | Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks Receives: Drug: Dactolisib |
| Placebo | Placebo comparator | Oral matching placebo once daily for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with clinically symptomatic respiratory illness
Measured: Through Week 16
Secondary outcomes (7)
Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s)
Measured: Through Week 16
Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen)
Measured: Through Week 16
Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s)
Measured: Through Week 16
Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness
Measured: Through Week 16
Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses
Measured: Through Week 16
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Measured: Through Week 20
Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses
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.
Measured: Through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start21 Oct 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Why it stopped: Phase 3 trial RTB-101-204 study did not meet its primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinically Symptomatic Respiratory IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restorbio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Restorbio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139915
- Sponsor's protocol ID
- RTB-101-205
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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):eaaq1564. doi: 10.1126/scitranslmed.aaq1564.
PubMed 29997249
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
- ClinicalTrials.gov ID
- NCT04139915
- Acronym / sponsor ID
- RTB-101-205
- Keywords
- Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Phase 3 trial RTB-101-204 study did not meet its primary endpoint
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Restorbio Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg daily RTB101 | Experimental | Drug: DactolisibOral RTB101 10 mg hard gelatin capsule once daily for 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral matching placebo once daily for 16 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DactolisibAlso: RTB101, BEZ235TORC1 inhibitor | Drug | 10 mg daily RTB101 |
| PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
Percentage of subjects with clinically symptomatic respiratory illness
Time frame: Through Week 16
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Background: PubMed 29997249Mannick 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Restorbio Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dactolisib in people with Clinically Symptomatic Respiratory Illness, run by Restorbio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with clinically symptomatic respiratory illness (time frame: Through Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.