Amyotrophic Lateral SclerosisPhase 2NCT05039099
A Study to Evaluate, Safety, Tolerability, and PK of AP-101 in Participants With ALS
A Phase 2 study testing AP-101 in people with Amyotrophic Lateral Sclerosis, run by AL-S Pharma at 13 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- AP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 2 Sep 2021to 13 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must adhere to contraception restrictions
- Female participants of childbearing potential must adhere to contraception restrictions
- Have possible, clinically probable, clinically probable-laboratory supported or definite familial or sporadic ALS in accordance with the El-Escorial criteria or who have a diagnosis of ALS as defined by the Gold Coast Criteria; progressive motor impairment documented by history or repeated clinical examination, preceded by normal motor development, and presence of upper and lower motor neuron dysfunction in at least 1 body region or lower motor neuron dysfunction in at least 2 body regions and investigations excluding other conditions
- In familial ALS participants, a confirmed pathogenic superoxide dismutase 1 (SOD1) mutation
- Onset of symptoms (i.e, weakness) within past 24 months prior to screening, at the time of obtaining informed consent
- Have slow vital capacity (SVC) of greater than or equal to (> or =) 50 percentage (%) of predicted values. Participants with SVC of <50% of predicted values may be permitted to enter the open-label extension, based on the opinion of the investigator
Show all 12Show fewer
- Absence of bilevel positive airway pressure (BiPAP)/proportional assist ventilation (PAV) > 4 hours for symptoms attributable to ALS. Use of a CPAP for pre-existing conditions will be allowed
- If on riluzole, must be on a stable dose.
- If on edaravone, must have completed 2 cycles and are expected to remain on the same dose throughout the study
- Able to provide informed consent which includes compliance with the requirements and restrictions
- Have venous access sufficient to allow for blood sampling
- Have clinical laboratory test results within the normal reference range for the population or study site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Who cannot join
- Have participated or currently participating in another clinical trial within 5 half-lives of baseline (Day 1)
- Have undergone a tracheostomy for ALS symptoms
- Are on nasal intermittent positive pressure ventilation (NIPPV) >4 hours per day for the treatment of ALS related symptoms
- Have other causes of neuromuscular weakness
- Have cognitive impairment, severe disease in the cardiovascular, hematological, renal system, neurodegenerative disease, pulmonary disorder, or psychiatric illness
- Pregnant or nursing women
- Have been exposed to any antisense treatment targeting SOD1 within 6 months of the baseline visit
- Have undergone stem cell therapy
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Canada4 sites
ALS clinic at the Kaye Edmonton Clinic, University of Alberta
Edmonton, Alberta, AB T6G 1Z1
London Health Sciences Centre - Victoria Hospital
London, Ontario, ON N6A 5W9
Montreal Neurological Institute and Hospital / Dr Genge
Montreal, Quebec, H3A 2B4
ALS Research Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Germany4 sites
Charité
Berlin, 13353
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
Bonn, 53127
Hannover Medical School
Hanover, 30625
Ulm University Hospital
Ulm, 89081
Sweden2 sites
Studieenheten Akademiskt specialistcentrum, SLSO
Stockholm, 113 61
Norrlands universitetssjukhus/ University Hospital of Northern Sweden (NUS)
Umeå, SE- 901 85
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of AP-101 in Participants With Sporadic or SOD1-Associated ALS
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Read the detailed description
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic markers of AP-101 in adults with sporadic ALS or SOD1-associated ALS. A total of 73 participants were randomized within each ALS cohort in a 2:1 ratio to receive AP-101 or placebo during a 24-week double-blind treatment period.
Participants assigned to AP-101 received a 500 mg intravenous loading dose on Day 1, a 2500 mg intravenous dose on Day 2, and 2500 mg intravenously every 3 weeks beginning on Day 22 through Week 24. Participants assigned to placebo received matching intravenous infusions on the same schedule. Stable use of locally approved ALS treatments was permitted.
Participants who completed the double-blind period could enter an optional 24-week open-label extension in which all participants received AP-101. To maintain the integrity of the double-blind period, the initial dose in the open-label extension remained blinded. Participants were followed for safety and pharmacokinetic assessments for up to 16 weeks after their final study dose.
The primary assessments evaluated adverse events, serious adverse events, immunogenicity, vital signs, clinical laboratory assessments, physical and neurological examinations, electrocardiograms, and changes in weight. Secondary assessments included serum pharmacokinetics, AP-101 concentrations in cerebrospinal fluid, and the neurofilament biomarkers phosphorylated neurofilament heavy chain (pNfH) and neurofilament light chain (NfL). Exploratory assessments included the ALS Functional Rating Scale-Revised, slow vital capacity, muscle strength, King's staging, survival and ventilation outcomes, quality of life, and cerebrospinal fluid total and misfolded SOD1.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- AP-101, Placebo
- Keywords
- Familial Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Amyotrophic lateral sclerosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-101Drug
Participants receive AP-101 by intravenous infusion (IV).
PlaceboDrug
Participants receive placebo by intravenous infusion (IV).
| Study group | Role | What they receive |
|---|---|---|
| AP-101 | Experimental | AP-101 is administered by intravenous infusion (IV). Receives: Drug: AP-101 |
| Placebo | Placebo comparator | Placebo is administered by intravenous infusion (IV). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period
Treatment-emergent adverse events were adverse events that began or worsened after the first dose of randomized study treatment during the double-blind period. Treatment-emergent serious adverse events met the protocol-defined criteria for seriousness. Participants experiencing more than one event within a category were counted once in that category. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts.
Measured: From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks
Number of Participants With Abnormalities in Vital Signs, Clinical Laboratory Assessments, Physical and Neurological Examinations, and Electrocardiograms
Number of participants with at least one abnormality in vital signs, clinical laboratory assessments, physical examinations, neurological examinations, or electrocardiograms during the double-blind period. Participants could be included in more than one category; therefore, categories were not mutually exclusive. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts.
Measured: From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks
Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) During the Double-Blind Period
Serum samples were assessed for anti-drug antibodies to AP-101. Participants were evaluable for treatment-emergent anti-drug antibodies if they had at least one non-missing baseline result and at least one non-missing post-baseline result. One participant was anti-drug-antibody positive at baseline and subsequently tested negative; baseline positivity was not classified as treatment-emergent. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts. ADA testing was not assessed in placebo participants.
Measured: From baseline through the 21-day follow-up after Week 24, approximately 27 weeks
Secondary outcomes (6)
Model-Derived Elimination Half-Life of AP-101 in Serum
The individual elimination half-life of AP-101 was estimated using empirical Bayes estimates from the final two-compartment population pharmacokinetic model. The model used pooled serum AP-101 concentration data from studies AP101-01 and AP101-02. This outcome summarizes participants from AP101-02 who were included in the final population pharmacokinetic model.
Measured: From the first AP-101 dose through 16 weeks after the final AP-101 dose, up to approximately 64 weeks
Model-Derived Area Under the Serum AP-101 Concentration-Time Curve
Individual AP-101 exposure was estimated using empirical Bayes estimates from the final two-compartment population pharmacokinetic model. Area under the concentration-time curve during the dosing interval was estimated following the second active AP-101 dose and at steady state. This outcome summarizes AP101-02 participants included in the final population pharmacokinetic model.
Measured: AUC following the second active dose: Day 2 through Day 22; AUC at steady state: the 21-day dosing interval following the participant's final active AP-101 dose, which occurred up to approximately Week 48 of the study
Model-Derived Maximum Serum AP-101 Concentration
Individual maximum serum AP-101 concentrations were estimated using empirical Bayes estimates from the final two-compartment population pharmacokinetic model. Maximum concentration was estimated following the second active AP-101 dose and at steady state. This outcome summarizes AP101-02 participants included in the final population pharmacokinetic model.
Measured: Cmax following the second active dose: Day 2 through Day 22; Cmax at steady state: during the 21-day dosing interval following the participant's final active AP-101 dose, which occurred up to approximately Week 48 of the study.
AP-101 Concentration in Cerebrospinal Fluid During the Double-Blind Period
AP-101 concentrations were measured in cerebrospinal fluid to assess central nervous system exposure after repeated intravenous dosing. Samples were collected at Week 12 and Week 24 of the double-blind period and summarized by ALS cohort and visit among participants with quantifiable CSF AP-101 concentrations. Actual concentrations were reported rather than change from baseline because nearly all baseline concentrations were below the limit of quantitation.
Measured: Week 12 and Week 24 of the double-blind period
Change From Baseline in Cerebrospinal Fluid Phosphorylated Neurofilament Heavy Chain (pNfH) During the Double-Blind Period
Phosphorylated neurofilament heavy chain (pNfH) concentrations were measured in cerebrospinal fluid at baseline, Week 12, and Week 24. Results represent the mean change from baseline and are presented separately for the sporadic ALS and SOD1-ALS cohorts. Negative values indicate a decrease from baseline.
Measured: Baseline to Week 24 of the double-blind period
Change From Baseline in Serum Neurofilament Light Chain During the Double-Blind Period and 21-Day Follow-up
Neurofilament light chain (NfL) concentrations were measured in serum at baseline, Week 12, Week 24, and the 21-day follow-up after completion of double-blind treatment. Results represent the mean change from baseline and are presented separately for the sporadic ALS and SOD1-ALS cohorts. Negative values indicate a decrease from baseline.
Measured: Baseline through the 21-day follow-up after Week 24, approximately 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start2 Sep 2021
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
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 Amyotrophic Lateral SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- AL-S Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, AL-S Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039099
- Sponsor's protocol ID
- AP101-02
- Other IDs
- 2020-005971-11
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2021
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of AP-101 in Participants With Sporadic or SOD1-Associated ALS
- ClinicalTrials.gov ID
- NCT05039099
- Acronym / sponsor ID
- AP101-02
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Familial Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AL-S PharmaIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Posted 30 Sep 2026
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 evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Detailed description
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic markers of AP-101 in adults with sporadic ALS or SOD1-associated ALS. A total of 73 participants were randomized within each ALS cohort in a 2:1 ratio to receive AP-101 or placebo during a 24-week double-blind treatment period.
Participants assigned to AP-101 received a 500 mg intravenous loading dose on Day 1, a 2500 mg intravenous dose on Day 2, and 2500 mg intravenously every 3 weeks beginning on Day 22 through Week 24. Participants assigned to placebo received matching intravenous infusions on the same schedule. Stable use of locally approved ALS treatments was permitted.
Participants who completed the double-blind period could enter an optional 24-week open-label extension in which all participants received AP-101. To maintain the integrity of the double-blind period, the initial dose in the open-label extension remained blinded. Participants were followed for safety and pharmacokinetic assessments for up to 16 weeks after their final study dose.
The primary assessments evaluated adverse events, serious adverse events, immunogenicity, vital signs, clinical laboratory assessments, physical and neurological examinations, electrocardiograms, and changes in weight. Secondary assessments included serum pharmacokinetics, AP-101 concentrations in cerebrospinal fluid, and the neurofilament biomarkers phosphorylated neurofilament heavy chain (pNfH) and neurofilament light chain (NfL). Exploratory assessments included the ALS Functional Rating Scale-Revised, slow vital capacity, muscle strength, King's staging, survival and ventilation outcomes, quality of life, and cerebrospinal fluid total and misfolded SOD1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP-101 | Experimental | Drug: AP-101AP-101 is administered by intravenous infusion (IV). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered by intravenous infusion (IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All participants must adhere to contraception restrictions
- Female participants of childbearing potential must adhere to contraception restrictions
- Have possible, clinically probable, clinically probable-laboratory supported or definite familial or sporadic ALS in accordance with the El-Escorial criteria or who have a diagnosis of ALS as defined by the Gold Coast Criteria; progressive motor impairment documented by history or repeated clinical examination, preceded by normal motor development, and presence of upper and lower motor neuron dysfunction in at least 1 body region or lower motor neuron dysfunction in at least 2 body regions and investigations excluding other conditions
- In familial ALS participants, a confirmed pathogenic superoxide dismutase 1 (SOD1) mutation
- Onset of symptoms (i.e, weakness) within past 24 months prior to screening, at the time of obtaining informed consent
Key exclusion criteria (8 listed)
- Have participated or currently participating in another clinical trial within 5 half-lives of baseline (Day 1)
- Have undergone a tracheostomy for ALS symptoms
- Are on nasal intermittent positive pressure ventilation (NIPPV) >4 hours per day for the treatment of ALS related symptoms
- Have other causes of neuromuscular weakness
- Have cognitive impairment, severe disease in the cardiovascular, hematological, renal system, neurodegenerative disease, pulmonary disorder, or psychiatric illness
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 |
|---|---|---|
| AP-101Participants receive AP-101 by intravenous infusion (IV). | Drug | AP-101 |
| PlaceboParticipants receive placebo by intravenous infusion (IV). | Drug | Placebo |
Primary outcome
Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period
Time frame: From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks
Treatment-emergent adverse events were adverse events that began or worsened after the first dose of randomized study treatment during the double-blind period. Treatment-emergent serious adverse events met the protocol-defined criteria for seriousness. Participants experiencing more than one event within a category were counted once in that category. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts.
Number of Participants With Abnormalities in Vital Signs, Clinical Laboratory Assessments, Physical and Neurological Examinations, and Electrocardiograms
Time frame: From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks
Number of participants with at least one abnormality in vital signs, clinical laboratory assessments, physical examinations, neurological examinations, or electrocardiograms during the double-blind period. Participants could be included in more than one category; therefore, categories were not mutually exclusive. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts.
Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) During the Double-Blind Period
Time frame: From baseline through the 21-day follow-up after Week 24, approximately 27 weeks
Serum samples were assessed for anti-drug antibodies to AP-101. Participants were evaluable for treatment-emergent anti-drug antibodies if they had at least one non-missing baseline result and at least one non-missing post-baseline result. One participant was anti-drug-antibody positive at baseline and subsequently tested negative; baseline positivity was not classified as treatment-emergent. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts. ADA testing was not assessed in placebo participants.
6 secondary outcomes
Model-Derived Elimination Half-Life of AP-101 in Serum
Time frame: From the first AP-101 dose through 16 weeks after the final AP-101 dose, up to approximately 64 weeks
Model-Derived Area Under the Serum AP-101 Concentration-Time Curve
Time frame: AUC following the second active dose: Day 2 through Day 22; AUC at steady state: the 21-day dosing interval following the participant's final active AP-101 dose, which occurred up to approximately Week 48 of the study
Model-Derived Maximum Serum AP-101 Concentration
Time frame: Cmax following the second active dose: Day 2 through Day 22; Cmax at steady state: during the 21-day dosing interval following the participant's final active AP-101 dose, which occurred up to approximately Week 48 of the study.
AP-101 Concentration in Cerebrospinal Fluid During the Double-Blind Period
Time frame: Week 12 and Week 24 of the double-blind period
Change From Baseline in Cerebrospinal Fluid Phosphorylated Neurofilament Heavy Chain (pNfH) During the Double-Blind Period
Time frame: Baseline to Week 24 of the double-blind period
Change From Baseline in Serum Neurofilament Light Chain During the Double-Blind Period and 21-Day Follow-up
Time frame: Baseline through the 21-day follow-up after Week 24, approximately 27 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
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.
Study Director study director
AL-S Pharma AG
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP-101 in people with Amyotrophic Lateral Sclerosis, run by AL-S Pharma at 13 sites in 6 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 12 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Germany, Sweden, United States, Belgium and 1 more country. 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 30 Sep 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?
Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period (time frame: From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks). 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 30 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.