RSV InfectionPhase 2NCT06784973
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study testing Obeldesivir in people with RSV Infection, run by Gilead Sciences at 56 sites in 2 countries.
Trial summary
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- RSV Infection
- What is being tested?
- Obeldesivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 5 Mar 2025to 16 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
- Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 3 kg to < 40 kg (Part A) and ≥ 1.5 kg to < 3 kg (Part B)
- Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
- RSV infection diagnosis ≤ 3 days prior to randomization.
- Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization.
- Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
- Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Who cannot join
- Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
- Not expected to survive the current RSV-related illness.
- Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
- History of asthma or recurrent wheezing.
- Neuromuscular disease that affects swallowing.
Show all 14Show fewer
- Cystic fibrosis.
- Participants who are immunocompromised.
- Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
- Abnormal renal function.
- Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
- Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
- Participant whose mother received RSV vaccination during pregnancy and who is < 1 year old prior to randomization.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
United States41 sites
Children's of Alabama
Birmingham, Alabama, 35233
Helios Clinical Research
Burleson, Texas, 76028
Epic Medical Research -Oklahoma
Chickasha, Oklahoma, 73018
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
Dolphin Medical Research
Doral, Florida, 33172
PAS Research
Edinburg, Texas, 78539
Boeson Research
Great Falls, Montana, 59405
Helios Clinical Research
Houston, Texas, 77008
Biopharma Informatic, LLC
Houston, Texas, 77043
Sunrise Pediatrics
Houston, Texas, 77077
Biopharma Informatic, LLC
Houston, Texas, 77084
Pioneer Research Solutions Inc.
Houston, Texas, 77099
Clinical Research Prime
Idaho Falls, Idaho, 83404
Boeson Research
Kalispell, Montana, 59901
Tanner Clinic
Kaysville, Utah, 84037
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508
Radiance Clinical Research
Lampasas, Texas, 76550
Tanner Clinic
Layton, Utah, 84041
UCLA (Outpatient Clinic)
Los Angeles, California, 90095
Alliance Research Institute
Lynwood, California, 90262
Boeson Research
Missoula, Montana, 59804
Paradigm Clinical Research
Modesto, California, 95355
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Midway Medical Clinic
Oneonta, Alabama, 35121
Nona Pediatric Center
Orlando, Florida, 32829
Cohen Children's Medical Center Pharmacy New Pavillion
Phoenix, Arizona, 11040
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85015
PAS Research
Pittsburgh, Pennsylvania, 15227
Boeson Research PVU
Provo, Utah, 84604
Pediatric Center
Richmond, Texas, 77469
Central Texas Medical Research, LLC
San Antonio, Texas, 78232
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108
FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
Santa Maria, California, 93454
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
Child Health Care Associates
Syracuse, New York, 13210
PAS Research
Tampa, Florida, 33613
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, 77375
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016
Tekton Research, LLC
Yukon, Oklahoma, 73099
Japan15 sites
Yoshimura Child Clinic
Akashi, 674-0068
Japan Community Healthcare Organization Kyushu Hospital
Fkitakyushu, 806-0034
Uchida child clinic
Fukuoka, 814-0104
Shindo Children's Clinic
Fukuoka, 814-0121
SEKI Children's CLINIC
Fukuoka, 814-0123
Ryuseidai Children's Clinic
Ibaraki, 305-0008
Isesaki Municipal Hospital
Isesaki, 372-0817
Abe Child Clinic
Kanagawa, 223-0051
Okada Kodomonomori Clinic
Kasukabe, 344-0011
Yutaka Children Clinic
Kobe, 651-2273
Kochi Health Sciences Center
Kochi, 781-8555
Japan Community Healthcare Organization Chukyo Hospital
Nagoya
Shimamura Memorial Hospital
Nerima-ku, 177-0051
Shizuoka Welfare Hospital
Shizuoka, 420-0005
Shizuoka City Shimizu Hospital
Shizuoka, 424-8636
About this study
Official title: A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve.
The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
Read the detailed description
Pediatric participants will be enrolled as follows:
- Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg
- Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
- Conditions
- RSV Infection
- Being tested
- Obeldesivir, Obeldesivir Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeldesivirDrug
Also called ODV, GS-5245
Administered orally
Obeldesivir PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Experimental | Participants weighing ≥ 12 kg to < 20 kg, will receive ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. Receives: Drug: Obeldesivir |
| Cohort 1: Part A (Group 3) - ODV | Experimental | Participants weighing ≥ 6 kg to < 12 kg, will receive ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. Receives: Drug: Obeldesivir |
| Cohort 1: Part A (Group 3) - Placebo | Placebo comparator | Participants weighing ≥ 6 kg to < 12 kg, will receive placebo-to-match ODV, orally, twice daily on Days 1 to 5. Receives: Drug: Obeldesivir Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28
TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28.
Measured: Up to Day 28
Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28.
Measured: Up to Day 28
Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28
Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Measured: Up to Day 28
Secondary outcomes (8)
PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir
AUCtau is defined as area under the plasma concentration-time curve during a dosing interval (AUCtau) of GS-441524, the active metabolite of obeldesivir.
Measured: Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir
Cmax is defined as maximum plasma concentration of GS-441524, the active metabolite of obeldesivir.
Measured: Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir
Ctrough is defined as the trough observed drug concentration [measured concentration at predose of Day 5 (taken directly before next administration)].
Measured: Day 5: Predose
Change From Baseline in RSV Nasal Swab Viral Load at Day 5
Nasal swab samples was used to assess RSV viral load by reversetranscriptase-quantitative polymerase chain reaction (RT-qPCR), respiratory coinfection by multiplex respiratory pathogen PCR, potential infectious viral titer assessment, and potential resistance testing (by sequencing and/or phenotyping). Baseline was defined as the last available value collected on or prior to first dose of study drug.
Measured: Baseline, Day 5
Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28
Sustained alleviation of targeted RSV symptoms was defined as 3 daily consecutive assessments (48-hour period) with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1; or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to sustained alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Measured: Up to Day 28
Time to Resolution of Targeted RSV Symptoms by Day 28
Resolution of targeted RSV symptoms was defined as: for 2 daily consecutive assessments, improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score >2; no increase or an improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score of 2; no increase in score for any targeted RSV symptom with baseline score of 1. The time to resolution of targeted RSV symptoms by Day 28 was calculated as the resolution date/time minus the first dose date/time. Targeted RSV symptoms referred to RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Measured: Up to Day 28
Number of Participants With Palatability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Caregivers were asked to rate how the study drug tasted to their child. A questionnaire was administered to caregivers to assess palatability. Palatability was assessed by caregivers using a questionnaire on Day 1 and Day 5 with response options: Super Good, Good, Maybe Good or Maybe Bad, Bad, or Super Bad.
Measured: Days 1 and 5
Number of Participants With Acceptability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Caregivers were asked to evaluate how easy it was for children to take the study drug. A questionnaire was administered to caregivers to assess acceptability. Acceptability was assessed by caregivers using a questionnaire with response options: Super Easy, Easy, Maybe Easy or Maybe Hard, Hard, or Super Hard. The questionnaire evaluated how easy it was for children to take the study drug.
Measured: Days 1 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Mar 2025
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Why it stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784973
- Sponsor's protocol ID
- GS-US-685-6883
- Other IDs
- jRCT2031240735
- Status last verified
- May 2026
- First submitted
- 15 Jan 2025
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection
- ClinicalTrials.gov ID
- NCT06784973
- Acronym / sponsor ID
- GS-US-685-6883
- Conditions
- RSV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve.
The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
Detailed description
Pediatric participants will be enrolled as follows:
- Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg
- Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Experimental | Drug: ObeldesivirParticipants weighing ≥ 12 kg to < 20 kg, will receive ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. |
| Cohort 1: Part A (Group 3) - ODV | Experimental | Drug: ObeldesivirParticipants weighing ≥ 6 kg to < 12 kg, will receive ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. |
| Cohort 1: Part A (Group 3) - Placebo | Placebo comparator | Drug: Obeldesivir PlaceboParticipants weighing ≥ 6 kg to < 12 kg, will receive placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
- RSV infection diagnosis ≤ 3 days prior to randomization.
- Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization.
- Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
- Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Key exclusion criteria (14 listed)
- Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
- Not expected to survive the current RSV-related illness.
- Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
- History of asthma or recurrent wheezing.
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 |
|---|---|---|
| ObeldesivirAlso: ODV, GS-5245Administered orally | Drug | Cohort 1: Part A (Group 2) - Obeldesivir (ODV), Cohort 1: Part A (Group 3) - ODV |
| Obeldesivir PlaceboAdministered orally | Drug | Cohort 1: Part A (Group 3) - Placebo |
Primary outcome
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28
Time frame: Up to Day 28
TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28.
Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28
Time frame: Up to Day 28
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28.
Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28
Time frame: Up to Day 28
Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
8 secondary outcomes
PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir
Time frame: Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir
Time frame: Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir
Time frame: Day 5: Predose
Change From Baseline in RSV Nasal Swab Viral Load at Day 5
Time frame: Baseline, Day 5
Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28
Time frame: Up to Day 28
Time to Resolution of Targeted RSV Symptoms by Day 28
Time frame: Up to Day 28
Number of Participants With Palatability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Time frame: Days 1 and 5
Number of Participants With Acceptability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Time frame: Days 1 and 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RSV
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.
Gilead Study Director study director
Gilead Sciences
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obeldesivir in people with RSV Infection, run by Gilead Sciences at 56 sites in 2 countries.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28 (time frame: Up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.