Spinal Muscular AtrophyPhase 3SOLARNCT07444476
A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam
A Phase 3 study testing Salanersen in people with Spinal Muscular Atrophy, run by Biogen at 3 sites in 2 countries.
Trial summary
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Spinal Muscular Atrophy
- What is being tested?
- Salanersen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Sep 2026to 22 Jun 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants aged 15 to 60 years, inclusive, at the time of informed consent
- Participants with genetic documentation of 5q Spinal Muscular Atrophy (SMA) (homozygous gene deletion or mutation or compound heterozygous mutation).
- Participants with clinical signs and symptoms consistent with SMA.
- Survival motor neuron 2 (SMN2) copy number ≥ 1.
- Participants with baseline Hammersmith Functional Motor Scale - Expanded (HFMSE) total score of ≥ 10 to ≤ 54.
- Participants who are able to sit without using support for at least 10 seconds.
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- Participants with no prior treatment with myostatin inhibitors and a willingness to remain off concurrent myostatin inhibitor therapy for the duration of the study.
- Ambulatory and nonambulatory participants:
- Ambulatory participants must be able to walk at least 10 meters independently without assistance and are willing and able to complete the 6 Minute Walk Test (6MWT) at Screening.
- For participants in the treatment-naïve cohort:
- No prior treatment with an approved SMA Disease Modifying Therapy (DMT) or an investigational drug given for the treatment of SMA.
- For participants in the risdiplam-treated cohort:
- Currently receiving risdiplam treatment and have been on once-daily 5 milligrams (mg) risdiplam treatment for at least 6 months prior to Screening.
- Willing to stop risdiplam therapy for the duration of the study. The last dose of risdiplam must be taken the day before the first dose of salanersen.
- No prior treatment with nusinersen, onasemnogene abeparvovec-xioi/onasemnogene abeparvovec-brve (OA), other approved DMTs for SMA or investigational drugs given for the treatment of SMA apart from risdiplam.
Who cannot join
- Respiratory insufficiency at Screening, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period (except for nocturnal bilevel positive airway pressure).
- Medical necessity for a gastric feeding tube, where the majority of nutrition is provided by this route, as assessed by the site Investigator at Screening.
- History of brain or spinal cord disease or other contraindications (e.g., severe scoliosis) that would interfere with the lumbar puncture (LP) procedures, Cerebrospinal fluid (CSF) circulation, efficacy assessments, or safety assessments (including a history of hydrocephalus or implanted shunt for CSF drainage), as assessed by the Investigator.
- Hospitalization for surgery, a pulmonary event, or nutritional support within 2 months prior to Screening or plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the end of the study. Note: If prior scoliosis surgery has been performed, it must be done at least 1 year prior to Screening.
- Presence of an active medical issue (e.g., infection, recent fracture) that would make the participant unsuitable for inclusion, as assessed by the Investigator.
- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 90 days or 5 half-lives of the treatment (if known), whichever is longer, prior to Screening. This includes neuromodulation therapy such as spinal cord stimulation.
- Note: Other protocol-defined inclusion/exclusion criteria will apply.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Childrens Hospital of the Kings Daughter Norfolk
Norfolk, Virginia, 23507
757-668-6981
Crystal Proud
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94304
650-725-7622
John Day
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
About this study
Official title: An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen.
Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. In most people living with SMA, changes to or a lack of a gene called survival motor neuron 1 (SMN1) - often referred to as gene mutations or variants - affect how this gene works. As a result, their bodies produce less SMN protein. Without enough of this protein, motor neurons and muscles cannot work properly. There is a similar gene called SMN2 that produces SMN protein, but it usually does not produce enough SMN protein on its own to make up for the changes in the SMN1 gene. Salanersen is a drug designed to help the SMN2 gene to make more working SMN protein.
Read more
In this study, there will be 2 groups of participants: a group who has never received treatment for SMA before joining this study, and a group who has been treated with risdiplam, an approved drug for SMA . Those participants must not have received any other SMA treatments before and will need to stop their risdiplam treatment for the duration of the study.
The main goal of this study is to learn more about how salanersen affects the participants' motor function. Researchers will use different tests and questionnaires to learn if motor function is changing over the study duration.
The main question researchers want to answer in this study is:
- For the group who has never been treated for SMA, how much do scores on the HFMSE movement test change at 12 months compared to the beginning of the study? The Hammersmith Functional Motor Scale - Expanded (HFMSE) has 33 activities that are scored which include sitting, lying down, walking, jumping, and more.
Researchers will also learn more about:
- The effects on participants' motor function and how well their nerves and muscles function.
- The effects on participants' overall sense of change and how they perform daily activities.
- How many participants have adverse events or serious adverse events. Adverse events are health problems that may or may not be caused by the study drug.
- How much salanersen gets into the fluid surrounding the brain and spinal cord.
- How much salanersen gets into the blood.
This study will be done as follows:
- First, participants will be screened to check if they can join the study. The screening period may be up to 4 weeks.
- This is an "open-label" study. This is a study in which the participants, study doctor, and site staff will know that participants are receiving salanersen.
- All participants will receive salanersen through an intrathecal injection, or one that is given into the fluid surrounding the brain and spinal cord.
- Participants will receive salanersen once every year for a total of 5 times throughout the study.
- Including screening, participants will have 17 study visits and 9 telephone calls during this study, which will last up to 61 months in total.
Read the detailed description
The primary objective of the SOLAR study is to evaluate the clinical efficacy of salanersen in participants with SMA who are treatment-naïve or previously treated with risdiplam. The secondary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of salanersen.
- Conditions
- Spinal Muscular Atrophy
- Being tested
- Salanersen
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalanersenDrug
Also called BIIB115
Administered Intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Naïve Cohort | Experimental | Treatment-naïve participants will receive salanersen 80 milligrams (mg) by intrathecal (IT) lumbar puncture (LP) every 12 months for a total of five doses. Receives: Drug: Salanersen |
| Risdiplam-Treated Cohort | Experimental | Risdiplam-treated participants will receive salanersen 80 mg by IT LP every 12 months for a total of five doses. Receives: Drug: Salanersen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Total Score in Treatment-Naïve Cohort
The HFMSE is a tool used to assess motor function in individuals with SMA. Participants will be asked to complete a specific movement and are then graded on the quality and execution of that movement. Higher scores indicate higher levels of motor ability. The overall score is the sum of the scores for all 33 items, with a maximum score of 66 with higher scores depicting better ability to perform activities.
Measured: At Month 12
Secondary outcomes (12)
Percentage of Participants With ≥ 3-Point Change From Baseline in HFMSE Total Score
The HFMSE is a tool used to assess motor function in individuals with SMA. Participants will be asked to complete a specific movement and are then graded on the quality and execution of that movement. Higher scores indicate higher levels of motor ability. The overall score is the sum of the scores for all 33 items, with a maximum score of 66 with higher scores depicting better ability to perform activities.
Measured: Up to Day 1825
Percentage of Participants With ≥ 2-Point Change From Baseline in Revised Upper Limb Module (RULM) Total Score
The RULM is developed to assess upper limb functional abilities of participants with SMA. This test consists of a total of 20 upper limb performance items that are reflective of activities of daily living. The RULM is scored from 0 to 37 points, with higher scores indicating better function.
Measured: Up to Day 1825
Percentage of Participants With ≥ 30-Meter Change From Baseline in 6-Minute Walk Test (6MWT) Distance (Ambulatory Participants Only)
The 6MWT is a submaximal exercise test used to assess an individual's functional exercise capacity. It measures the distance covered in 6 minutes on a flat, hard surface, providing valuable information about aerobic capacity and endurance.
Measured: Up to Day 1825
Change From Baseline in HFMSE Total Score
The HFMSE is a tool used to assess motor function in individuals with SMA. Participants will be asked to complete a specific movement and are then graded on the quality and execution of that movement. Higher scores indicate higher levels of motor ability. The overall score is the sum of the scores for all 33 items, with a maximum score of 66 with higher scores depicting better ability to perform activities.
Measured: Up to Day 1825
Change From Baseline in RULM Total Score
The RULM is developed to assess upper limb functional abilities of participants with SMA. This test consists of a total of 20 upper limb performance items that are reflective of activities of daily living. The RULM is scored from 0 to 37 points, with higher scores indicating better function.
Measured: Up to Day 1825
Change From Baseline in Total 6MWT Distance (Ambulatory Participants Only)
The 6MWT is a submaximal exercise test used to assess an individual's functional exercise capacity. It measures the distance covered in 6 minutes on a flat, hard surface, providing valuable information about aerobic capacity and endurance.
Measured: Up to Day 1825
Change From Baseline in Compound Muscle Action Potential (CMAP) Amplitudes
CMAP is a well validated method for tracking disease progression in neuromuscular disorders such as SMA and amyotrophic lateral sclerosis and has been proposed as a potential biomarker of a therapeutic effect in SMA. CMAPs will be performed for the following nerve-muscle pairs: ulnar-abductor digiti minimi and peroneal-tibialis anterior.
Measured: Up to Day 1825
Patient Global Impression of Change (PGI-C) Score
PGI-C is a self-reported 7-point scale evaluating the participant's perception of change in disease state since baseline. The scale ranges from 1 to 7, where 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Lower scores indicate clinical improvement, and higher scores indicate disease worsening.
Measured: Up to Day 1825
Change From Baseline in SMA Independence Scale - Upper Limb Module (SMAIS-ULM)
The SMAIS-ULM is a validated tool designed to assess the level of independence in daily activities related to upper limb functionality for individuals with Type II and nonambulant Type III SMA. The 22 items assess upper limb focused tasks across 5 domains of typical daily activities (bathing/hygiene, dressing, eating/drinking, picking up/moving objects, and other tasks) scored on a 3-point scale (0 = I cannot do this at all without help; 1 = I need some help; and 2 = I do not need help). Higher scores indicate greater independence.
Measured: Up to Day 1825
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 1825
Concentration of Salanersen in Cerebrospinal Fluid (CSF)
Measured: Up to Day 1460
Concentration of Salanersen in Serum
Measured: Up to Day 1825
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start8 Sep 2026
- Primary completion23 Jun 2028 (estimated)
- Study completion22 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by BiogenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444476
- Sponsor's protocol ID
- 277SM303
- Other IDs
- 2025-524054-34, 2025
- Acronym
- SOLAR
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam
- ClinicalTrials.gov ID
- NCT07444476
- Acronym / sponsor ID
- SOLAR / 277SM303
- Conditions
- Spinal Muscular Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 23 Jun 2028 (estimated)
- Study completion
- 22 Jun 2032 (estimated)
- First posted
- 3 Mar 2026 (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.
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen.
Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. In most people living with SMA, changes to or a lack of a gene called survival motor neuron 1 (SMN1) - often referred to as gene mutations or variants - affect how this gene works. As a result, their bodies produce less SMN protein. Without enough of this protein, motor neurons and muscles cannot work properly. There is a similar gene called SMN2 that produces SMN protein, but it usually does not produce enough SMN protein on its own to make up for the changes in the SMN1 gene. Salanersen is a drug designed to help the SMN2 gene to make more working SMN protein.
In this study, there will be 2 groups of participants: a group who has never received treatment for SMA before joining this study, and a group who has been treated with risdiplam, an approved drug for SMA . Those participants must not have received any other SMA treatments before and will need to stop their risdiplam treatment for the duration of the study.
The main goal of this study is to learn more about how salanersen affects the participants' motor function. Researchers will use different tests and questionnaires to learn if motor function is changing over the study duration.
The main question researchers want to answer in this study is:
- For the group who has never been treated for SMA, how much do scores on the HFMSE movement test change at 12 months compared to the beginning of the study? The Hammersmith Functional Motor Scale - Expanded (HFMSE) has 33 activities that are scored which include sitting, lying down, walking, jumping, and more.
Researchers will also learn more about:
- The effects on participants' motor function and how well their nerves and muscles function.
- The effects on participants' overall sense of change and how they perform daily activities.
- How many participants have adverse events or serious adverse events. Adverse events are health problems that may or may not be caused by the study drug.
- How much salanersen gets into the fluid surrounding the brain and spinal cord.
- How much salanersen gets into the blood.
This study will be done as follows:
- First, participants will be screened to check if they can join the study. The screening period may be up to 4 weeks.
- This is an "open-label" study. This is a study in which the participants, study doctor, and site staff will know that participants are receiving salanersen.
- All participants will receive salanersen through an intrathecal injection, or one that is given into the fluid surrounding the brain and spinal cord.
- Participants will receive salanersen once every year for a total of 5 times throughout the study.
- Including screening, participants will have 17 study visits and 9 telephone calls during this study, which will last up to 61 months in total.
Detailed description
The primary objective of the SOLAR study is to evaluate the clinical efficacy of salanersen in participants with SMA who are treatment-naïve or previously treated with risdiplam. The secondary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of salanersen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-Naïve Cohort | Experimental | Drug: SalanersenTreatment-naïve participants will receive salanersen 80 milligrams (mg) by intrathecal (IT) lumbar puncture (LP) every 12 months for a total of five doses. |
| Risdiplam-Treated Cohort | Experimental | Drug: SalanersenRisdiplam-treated participants will receive salanersen 80 mg by IT LP every 12 months for a total of five doses. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Participants aged 15 to 60 years, inclusive, at the time of informed consent
- Participants with genetic documentation of 5q Spinal Muscular Atrophy (SMA) (homozygous gene deletion or mutation or compound heterozygous mutation).
- Participants with clinical signs and symptoms consistent with SMA.
- Survival motor neuron 2 (SMN2) copy number ≥ 1.
- Participants with baseline Hammersmith Functional Motor Scale - Expanded (HFMSE) total score of ≥ 10 to ≤ 54.
Key exclusion criteria (7 listed)
- Respiratory insufficiency at Screening, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period (except for nocturnal bilevel positive airway pressure).
- Medical necessity for a gastric feeding tube, where the majority of nutrition is provided by this route, as assessed by the site Investigator at Screening.
- History of brain or spinal cord disease or other contraindications (e.g., severe scoliosis) that would interfere with the lumbar puncture (LP) procedures, Cerebrospinal fluid (CSF) circulation, efficacy assessments, or safety assessments (including a history of hydrocephalus or implanted shunt for CSF drainage), as assessed by the Investigator.
- Hospitalization for surgery, a pulmonary event, or nutritional support within 2 months prior to Screening or plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the end of the study. Note: If prior scoliosis surgery has been performed, it must be done at least 1 year prior to Screening.
- Presence of an active medical issue (e.g., infection, recent fracture) that would make the participant unsuitable for inclusion, as assessed by the Investigator.
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 |
|---|---|---|
| SalanersenAlso: BIIB115Administered Intrathecally | Drug | Risdiplam-Treated Cohort, Treatment-Naïve Cohort |
Primary outcome
Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Total Score in Treatment-Naïve Cohort
Time frame: At Month 12
The HFMSE is a tool used to assess motor function in individuals with SMA. Participants will be asked to complete a specific movement and are then graded on the quality and execution of that movement. Higher scores indicate higher levels of motor ability. The overall score is the sum of the scores for all 33 items, with a maximum score of 66 with higher scores depicting better ability to perform activities.
12 secondary outcomes
Percentage of Participants With ≥ 3-Point Change From Baseline in HFMSE Total Score
Time frame: Up to Day 1825
Percentage of Participants With ≥ 2-Point Change From Baseline in Revised Upper Limb Module (RULM) Total Score
Time frame: Up to Day 1825
Percentage of Participants With ≥ 30-Meter Change From Baseline in 6-Minute Walk Test (6MWT) Distance (Ambulatory Participants Only)
Time frame: Up to Day 1825
Change From Baseline in HFMSE Total Score
Time frame: Up to Day 1825
Change From Baseline in RULM Total Score
Time frame: Up to Day 1825
Change From Baseline in Total 6MWT Distance (Ambulatory Participants Only)
Time frame: Up to Day 1825
Change From Baseline in Compound Muscle Action Potential (CMAP) Amplitudes
Time frame: Up to Day 1825
Patient Global Impression of Change (PGI-C) Score
Time frame: Up to Day 1825
Change From Baseline in SMA Independence Scale - Upper Limb Module (SMAIS-ULM)
Time frame: Up to Day 1825
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 1825
Concentration of Salanersen in Cerebrospinal Fluid (CSF)
Time frame: Up to Day 1460
Concentration of Salanersen in Serum
Time frame: Up to Day 1825
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Connect to a Patient NavigatorLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salanersen in people with Spinal Muscular Atrophy, run by Biogen at 3 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 15 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Total Score in Treatment-Naïve Cohort (time frame: At Month 12). 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 2 Oct 2026.