Chronic Rhinosinusitis With Nasal PolypsPhase 1NCT05355207
Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis
A Phase 1 study testing TRL1068 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Trellis Bioscience LLC.
Trial summary
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- TRL1068
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2025
- Phase
- Phase 1
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years, inclusive
- Diagnosis of chronic rhinosinusitis with:
- Acute exacerbation of CRSwNP with increased sinonasal discharge OR
- Acute exacerbation post-functional endoscopic sinus surgery (FESS) with increased sinonasal discharge AND
- Sinonasal culture positive for SA or PA without concomitant fungal infection in culture or PCR
- Symptoms and culture results justify initiation of topical and/or systemic antibiotic treatment
Show all 9Show fewer
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled
- Men and women of child bearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before receiving the investigational product (IP) and through Day 50.
Who cannot join
- Active malignancy, or history of malignancy or chemotherapy within the past 2 years other than history of localized or surgical removal of focal skin cancer, or cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy
- Any chronic or acute bacterial infection other than acute exacerbation of CRS
- Concomitant intrasinal culture or 16S PCR indicative of concomitant fungal infection
- Allergic fungal rhinosinusitis, characterized by elevated antifungal IgE and eosinophilic mucus
- Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer)
- Received a COVID-19 vaccine or booster within 14 days of planned Day 1 or planned COVID-19 vaccination within 14 days after Day 1
Show all 9Show fewer
- Positive serum test for pregnancy, pregnant, or nursing women
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to comply with the study requirements
- Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL1068 in Subjects With Acute Exacerbation of Chronic Rhinosinusitis
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.
Read the detailed description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and decreased quality of life. Defects in the epithelial cell barrier, increased exposure to pathogenic and colonized bacteria, and dysregulation of the host immune system are all thought to play prominent roles in disease pathogenesis. Colonization with S. aureus or P. aureus are associated with recalcitrant disease and biofilm formation, making eradication difficult.
Distribution of topical solutions in the unoperated sinuses has been observed to be less than 2% of the total irrigation volume, with almost no penetration in the frontal and sphenoid sinuses. For those patients with mucosal edema from infection and chronic inflammation, distribution is probably significantly less when applied topically. Intravenously administered TRL1068 is expected to achieve effective anti-biofilm levels throughout the sinonasal space for several weeks. TRL1068 is a monoclonal human antibody that rapidly eliminates biofilm at very low concentrations, thus making the targeted bacterial pathogens substantially more sensitive to standard of care antibiotic treatment regimen and greatly accelerating clinical improvement and potential for bacterial eradication.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- TRL1068
- Keywords
- biofilm, antibiotic-resistant infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRL1068Drug
A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| TRL1068 | Experimental | all subjects will receive a single intravenous dose of 15 mg/kg of TRL1068 on Day 1 Receives: Drug: TRL1068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abnormal physical exam findings
Clinically-significant abnormal physical exam findings will be reviewed
Measured: 6 weeks
Incidence of abnormal serum chemistries and hematology
Clinically-significant abnormal laboratory results will be reviewed
Measured: 6 weeks
Incidence of abnormal vital signs (temperature)
Clinically-significant abnormal temperatures will be reviewed
Measured: 6 weeks
Incidence of abnormal vital signs (blood pressure)
Clinically-significant abnormal blood pressures will be reviewed
Measured: 6 weeks
Incidence of abnormal vital signs (heart rate)
Clinically-significant abnormal heart rates will be reviewed
Measured: 6 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
reported AEs and SAEs will be reviewed
Measured: 7 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Cmax)
Individual subject TRL1068 Cmax in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Cmin)
Individual subject TRL1068 Cmin in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Tmax)
Individual subject TRL1068 Tmax in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in serum (AUCLAST)
Individual subject TRL1068 AUCLAST in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in serum (AUCINF)
Individual subject TRL1068 AUCINF in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Cmax)
Individual subject TRL1068 Cmax intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Cmin)
Individual subject TRL1068 Cmin intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Tmax)
Individual subject TRL1068 Tmax intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (AUCLAST)
Individual subject TRL1068 AUCLAST intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (AUCINF)
Individual subject TRL1068 AUCINF intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Measured: 6 weeks
Characterize the pharmacodynamics (PD) of TRL1068 (time to resolution of bacterial pathogen infection)
Cultures will be tested for bacterial pathogen presence by bacterial culture and/or PCR assessment. Time to resolution of bacterial pathogen infection is defined as the number of days from start of current acute exacerbation to the day when testing by bacterial culture and/or PCR assessment are reported as negative. Descriptive statistics will be performed including mean, median and confidence interval.
Measured: 6 weeks
Characterize the pharmacodynamics (PD) of TRL1068 (time to resolution of signs and symptoms of acute exacerbation)
Patients will be evaluated for signs and symptoms of acute exacerbation using SNOT-22 scoring. Time to resolution of signs and symptoms of acute exacerbation is defined as the day when the SNOT-22 score is back to pre-acute exacerbation score.
Measured: 6 weeks
Assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)
Anti-drug antibodies (ADA), i.e. anti-TRL1068 antibodies in serum will determined by electrochemiluminescence assay
Measured: 6 weeks
Secondary outcomes (2)
Assess the incidence of improvement of baseline symptoms of chronic rhinosinusitis (CRS) after intravenous TRL1068
signs and symptoms will be measured using the SNOT-22
Measured: 7 weeks
Assess time to improvement of baseline symptoms of CRS as compared with previous duration of acute exacerbations
signs and symptoms will be measured using the SNOT-22 and compared with historical data
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, all subjects will receive 15 mg/kg of TRL1068 on Day 1
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trellis Bioscience LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355207
- Sponsor's protocol ID
- TRL1068-104
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make the Clinical Protocol and SAP available on Protocols.io (https://www.protocols.io/) before trial recruitment is complete.
Publications
Estelles A, Woischnig AK, Liu K, Stephenson R, Lomongsod E, Nguyen D, Zhang J, Heidecker M, Yang Y, Simon RJ, Tenorio E, Ellsworth S, Leighton A, Ryser S, Gremmelmaier NK, Kauvar LM. A High-Affinity Native Human Antibody Disrupts Biofilm from Staphylococcus aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2292-301. doi: 10.1128/AAC.02588-15. Print 2016 Apr.
PubMed 26833157Xiong YQ, Estelles A, Li L, Abdelhady W, Gonzales R, Bayer AS, Tenorio E, Leighton A, Ryser S, Kauvar LM. A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00904-17. doi: 10.1128/AAC.00904-17. Print 2017 Oct.
PubMed 28717038
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL1068 in Subjects With Acute Exacerbation of Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT05355207
- Acronym / sponsor ID
- TRL1068-104
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- biofilm, antibiotic-resistant infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Trellis Bioscience LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 2 May 2022 (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.
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.
Detailed description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and decreased quality of life. Defects in the epithelial cell barrier, increased exposure to pathogenic and colonized bacteria, and dysregulation of the host immune system are all thought to play prominent roles in disease pathogenesis. Colonization with S. aureus or P. aureus are associated with recalcitrant disease and biofilm formation, making eradication difficult.
Distribution of topical solutions in the unoperated sinuses has been observed to be less than 2% of the total irrigation volume, with almost no penetration in the frontal and sphenoid sinuses. For those patients with mucosal edema from infection and chronic inflammation, distribution is probably significantly less when applied topically. Intravenously administered TRL1068 is expected to achieve effective anti-biofilm levels throughout the sinonasal space for several weeks. TRL1068 is a monoclonal human antibody that rapidly eliminates biofilm at very low concentrations, thus making the targeted bacterial pathogens substantially more sensitive to standard of care antibiotic treatment regimen and greatly accelerating clinical improvement and potential for bacterial eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, all subjects will receive 15 mg/kg of TRL1068 on Day 1
| Arm | Type | Receives |
|---|---|---|
| TRL1068 | Experimental | Drug: TRL1068all subjects will receive a single intravenous dose of 15 mg/kg of TRL1068 on Day 1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 85 years, inclusive
- Diagnosis of chronic rhinosinusitis with:
- Symptoms and culture results justify initiation of topical and/or systemic antibiotic treatment
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled
Key exclusion criteria (9 listed)
- Active malignancy, or history of malignancy or chemotherapy within the past 2 years other than history of localized or surgical removal of focal skin cancer, or cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy
- Any chronic or acute bacterial infection other than acute exacerbation of CRS
- Concomitant intrasinal culture or 16S PCR indicative of concomitant fungal infection
- Allergic fungal rhinosinusitis, characterized by elevated antifungal IgE and eosinophilic mucus
- Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer)
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 |
|---|---|---|
| TRL1068A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody | Drug | TRL1068 |
Primary outcome
Incidence of abnormal physical exam findings
Time frame: 6 weeks
Clinically-significant abnormal physical exam findings will be reviewed
Incidence of abnormal serum chemistries and hematology
Time frame: 6 weeks
Clinically-significant abnormal laboratory results will be reviewed
Incidence of abnormal vital signs (temperature)
Time frame: 6 weeks
Clinically-significant abnormal temperatures will be reviewed
Incidence of abnormal vital signs (blood pressure)
Time frame: 6 weeks
Clinically-significant abnormal blood pressures will be reviewed
Incidence of abnormal vital signs (heart rate)
Time frame: 6 weeks
Clinically-significant abnormal heart rates will be reviewed
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 7 weeks
reported AEs and SAEs will be reviewed
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Cmax)
Time frame: 6 weeks
Individual subject TRL1068 Cmax in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Cmin)
Time frame: 6 weeks
Individual subject TRL1068 Cmin in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in serum (Tmax)
Time frame: 6 weeks
Individual subject TRL1068 Tmax in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in serum (AUCLAST)
Time frame: 6 weeks
Individual subject TRL1068 AUCLAST in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in serum (AUCINF)
Time frame: 6 weeks
Individual subject TRL1068 AUCINF in serum will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Cmax)
Time frame: 6 weeks
Individual subject TRL1068 Cmax intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Cmin)
Time frame: 6 weeks
Individual subject TRL1068 Cmin intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (Tmax)
Time frame: 6 weeks
Individual subject TRL1068 Tmax intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (AUCLAST)
Time frame: 6 weeks
Individual subject TRL1068 AUCLAST intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacokinetics (PK) of TRL1068 in intrasinal concentrations (AUCINF)
Time frame: 6 weeks
Individual subject TRL1068 AUCINF intrasinal will be determined by ELISA and derived PK parameters will be summarized using descriptive statistics.
Characterize the pharmacodynamics (PD) of TRL1068 (time to resolution of bacterial pathogen infection)
Time frame: 6 weeks
Cultures will be tested for bacterial pathogen presence by bacterial culture and/or PCR assessment. Time to resolution of bacterial pathogen infection is defined as the number of days from start of current acute exacerbation to the day when testing by bacterial culture and/or PCR assessment are reported as negative. Descriptive statistics will be performed including mean, median and confidence interval.
Characterize the pharmacodynamics (PD) of TRL1068 (time to resolution of signs and symptoms of acute exacerbation)
Time frame: 6 weeks
Patients will be evaluated for signs and symptoms of acute exacerbation using SNOT-22 scoring. Time to resolution of signs and symptoms of acute exacerbation is defined as the day when the SNOT-22 score is back to pre-acute exacerbation score.
Assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)
Time frame: 6 weeks
Anti-drug antibodies (ADA), i.e. anti-TRL1068 antibodies in serum will determined by electrochemiluminescence assay
2 secondary outcomes
Assess the incidence of improvement of baseline symptoms of chronic rhinosinusitis (CRS) after intravenous TRL1068
Time frame: 7 weeks
Assess time to improvement of baseline symptoms of CRS as compared with previous duration of acute exacerbations
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 26833157Estelles A, Woischnig AK, Liu K, Stephenson R, Lomongsod E, Nguyen D, Zhang J, Heidecker M, Yang Y, Simon RJ, Tenorio E, Ellsworth S, Leighton A, Ryser S, Gremmelmaier NK, Kauvar LM. A High-Affinity Native Human Antibody Disrupts Biofilm from Staphylococcus aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2292-301. doi: 10.1128/AAC.02588-15. Print 2016 Apr.
- Background: PubMed 28717038Xiong YQ, Estelles A, Li L, Abdelhady W, Gonzales R, Bayer AS, Tenorio E, Leighton A, Ryser S, Kauvar LM. A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00904-17. doi: 10.1128/AAC.00904-17. Print 2017 Oct.
- Individual participant dataSharing planned: Yes. We plan to make the Clinical Protocol and SAP available on Protocols.io (https://www.protocols.io/) before trial recruitment is complete.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRL1068 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Trellis Bioscience LLC.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anton (Tony) Leighton, MD (650-838-1400, Clinicalstudies@trellisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abnormal physical exam findings (time frame: 6 weeks). The study lists 19 primary outcomes in all. 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 NCT05355207, which also lists 2 linked publications.
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 12 Apr 2023.