Relapsed/Refractory Multiple MyelomaPhase 1/2NCT05427812
Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing ISB 1442 SC injection escalating doses and ISB 1442 SC injection at RP2D in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 15 sites in 3 countries.
Trial summary
This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- ISB 1442 SC injection escalating doses and ISB 1442 SC injection at RP2D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 27 Sep 2022to 19 Nov 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 years or older.
- Be willing and able to provide written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
- Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients):
- Must have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. (Note: Patients in Australia may have received any of the therapies including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit ).
- Must have measurable M-protein (serum and/or 24-hr urine, or serum free light chains).
- Phase 2: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients)
Show all 13Show fewer
- Have a body weight ≥ 40.0 kg at screening.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Have life expectancy of at least 3 months (from date of informed consent signing).
- Have adequate organ function, including:
- Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 × ULN; bilirubin ≤1.5 × ULN. Patients with Gilbert's syndrome may have a bilirubin level >1.5 × ULN, per discussion between the Investigator and medical monitor.
- Estimated creatinine clearance ≥45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine collection.
- Left ventricular ejection fraction (LVEF) ≥45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.
Who cannot join
- Participants with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
- Participants with MM with disease where the only measurable parameter is plasmacytoma.
- Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 1 month of C1D1; systemic anticancer treatments within 14 days before the first dose of study drug (C1D1) or any investigational products within 5 half-lives of C1D1, whichever is appropriate to last therapy received. (eg, non-IMP IMiD, proteasome inhibitor could be considered to be eligible if there is at least 14 days after last dose before C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/d for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand inhibitors are allowed.
- Received autologous stem cell transplantation within 12 weeks of C1D1.
- Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
- Prior radiation therapy within 14 days of C1D1; or prior irradiation to > 25% of the bone marrow. Note: Prophylactic localized ("spot") radiation for areas of pain is allowed.
Show all 10Show fewer
- Active malignant central nervous system involvement
- Known to be refractory to platelet or RBC transfusions
- Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
- QTc interval > 480 msec at screening using Fredericia's QT correction formula.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States6 sites
The University of Chicago Medical Center (UCMC) Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, 60637
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus
Detroit, Michigan, 48201
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
New York-Presbyterian /Weill Cornell Medical Center - The Myeloma Center
New York, New York, 10065
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Australia6 sites
Pindara Private Hospital
Benowa, Queensland, 4217
Royal Prince Albert Hospital: Institute of Haematology
Camperdown, New South Wales, 2050
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
The Alfred Hospital-Melbourne
Melbourne, Victoria, 3004
One Clinical Research Pty Ltd
Nedlands, Western Australia, 6009
Gold Coast University Hospital
Southport, Queensland, 4211
India3 sites
Health Care Global Enterprises Limited (HCG)
Bangalore
M S Ramaiah Medical College & Hospital
Bangalore
Max Super Speciality Hospital
Delhi
About this study
Official title: A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Participants With Relapsed/Refractory Multiple Myeloma
This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).
Read the detailed description
The study will be conducted in two phases:
- Phase 1: Dose escalation in R/R MM
- Phase 2: Dose expansions in select R/R MM
Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a Recommended Phase 2 Dose (RP2D) is established in Phase 1 for a given indication, Phase 2 will be initiated for that indication.
Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- ISB 1442 SC injection escalating doses, ISB 1442 SC injection at RP2D
- Keywords
- Open-label, dose-escalation, dose-expansion, ISB 1442, relapsed/refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISB 1442 SC injection escalating dosesDrug
Participants will receive escalating SC doses of ISB 1442
ISB 1442 SC injection at RP2DDrug
ISB 1442 SC injection dose regimen at RP2D until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose escalation | Experimental | Participants with R/R multiple myeloma (MM) will be administered ISB 1442 weekly by subcutaneous (SC) injection in each 28-day cycle. Dose escalation will begin with an accelerated titration dose escalation and should certain conversion criteria be met, escalation will convert to the standard (3 + 3) dose escalation Receives: Drug: ISB 1442 SC injection escalating doses |
| Phase 2 (Dose Expansion): R/R Multiple Myeloma | Experimental | This cohort includes the participants with pathologically confirmed R/R MM and must have received at least 3 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. Participants will receive the recommended Phase 2 Dose (RP2D) of ISB 1442 SC injection determined in Phase 1 of the study for treatment of R/R MM. Each treatment cycle duration is 28 days. The anticipated total duration for each participant will vary, depending on the number of cycles of treatment completed. The treatment phase will extend until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met. Receives: Drug: ISB 1442 SC injection at RP2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 18 months
Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)
Measured: Up to 28 days
Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Secondary outcomes (14)
Maximum Concentration (Cmax) of ISB 1442 in Serum
Measured: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum
Measured: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum
Measured: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum
Measured: Up to 28 days
Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)
Measured: Baseline to 18 months
Phase 1 and Phase 2: Time to Progression (TTP)
Measured: 18 Months
Phase 1 and Phase 2: Time to Next Treatment (TTNT)
Measured: 18 Months
Phase 1 and Phase 2: Time to Response (TTR)
Measured: 18 Months
Phase 1 and Phase 2: Progression free survival (PFS)
Measured: 18 Months
Phase 1 and Phase 2: Overall survival (OS)
Measured: 18 Months
Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start27 Sep 2022
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a recommended phase 2 Dose (RP2D) is established in Phase 1, Phase 2 will be initiated for that indication. The Phase 2 design uses the Simon two-stage design with stopping rules for lack of activity, as well as stopping rules for toxicity. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichnos Sciences SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427812
- Sponsor's protocol ID
- ISB 1442-101
- Status last verified
- Jan 2025
- First submitted
- 14 Jun 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Participants With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05427812
- Acronym / sponsor ID
- ISB 1442-101
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- Open-label, dose-escalation, dose-expansion, ISB 1442, relapsed/refractory multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ichnos Sciences SAIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 22 Jun 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.
This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).
Detailed description
The study will be conducted in two phases:
- Phase 1: Dose escalation in R/R MM
- Phase 2: Dose expansions in select R/R MM
Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a Recommended Phase 2 Dose (RP2D) is established in Phase 1 for a given indication, Phase 2 will be initiated for that indication.
Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a recommended phase 2 Dose (RP2D) is established in Phase 1, Phase 2 will be initiated for that indication. The Phase 2 design uses the Simon two-stage design with stopping rules for lack of activity, as well as stopping rules for toxicity. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose escalation | Experimental | Drug: ISB 1442 SC injection escalating dosesParticipants with R/R multiple myeloma (MM) will be administered ISB 1442 weekly by subcutaneous (SC) injection in each 28-day cycle. Dose escalation will begin with an accelerated titration dose escalation and should certain conversion criteria be met, escalation will convert to the standard (3 + 3) dose escalation |
| Phase 2 (Dose Expansion): R/R Multiple Myeloma | Experimental | Drug: ISB 1442 SC injection at RP2DThis cohort includes the participants with pathologically confirmed R/R MM and must have received at least 3 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. Participants will receive the recommended Phase 2 Dose (RP2D) of ISB 1442 SC injection determined in Phase 1 of the study for treatment of R/R MM. Each treatment cycle duration is 28 days. The anticipated total duration for each participant will vary, depending on the number of cycles of treatment completed. The treatment phase will extend until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients aged 18 years or older.
- Be willing and able to provide written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
- Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients):
- Phase 2: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients)
- Have a body weight ≥ 40.0 kg at screening.
Key exclusion criteria (10 listed)
- Participants with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
- Participants with MM with disease where the only measurable parameter is plasmacytoma.
- Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 1 month of C1D1; systemic anticancer treatments within 14 days before the first dose of study drug (C1D1) or any investigational products within 5 half-lives of C1D1, whichever is appropriate to last therapy received. (eg, non-IMP IMiD, proteasome inhibitor could be considered to be eligible if there is at least 14 days after last dose before C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/d for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand inhibitors are allowed.
- Received autologous stem cell transplantation within 12 weeks of C1D1.
- Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
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 |
|---|---|---|
| ISB 1442 SC injection escalating dosesParticipants will receive escalating SC doses of ISB 1442 | Drug | Phase 1: Dose escalation |
| ISB 1442 SC injection at RP2DISB 1442 SC injection dose regimen at RP2D until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met | Drug | Phase 2 (Dose Expansion): R/R Multiple Myeloma |
Primary outcome
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 18 months
Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)
Time frame: Up to 28 days
Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
14 secondary outcomes
Maximum Concentration (Cmax) of ISB 1442 in Serum
Time frame: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum
Time frame: Up to 28 days
Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)
Time frame: Baseline to 18 months
Phase 1 and Phase 2: Time to Progression (TTP)
Time frame: 18 Months
Phase 1 and Phase 2: Time to Next Treatment (TTNT)
Time frame: 18 Months
Phase 1 and Phase 2: Time to Response (TTR)
Time frame: 18 Months
Phase 1 and Phase 2: Progression free survival (PFS)
Time frame: 18 Months
Phase 1 and Phase 2: Overall survival (OS)
Time frame: 18 Months
Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ISB 1442 SC injection escalating doses and ISB 1442 SC injection at RP2D in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 15 sites in 3 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 13 inclusion and 10 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, India. 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 combined 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.
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?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
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?
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 18 months). 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 17 Jan 2025.