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NeoplasmsPhase 2NCT06790303

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2

A Phase 2 study testing Feladilimab and Ipilimumab in people with Neoplasms, run by GlaxoSmithKline at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess the clinical activity of novel regimen (Feladilimab plus Ipilimumab) in participants with NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Feladilimab and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesin 3 countries
Study dates
4 Mar 2021to 23 Sep 2021
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

  • Participants capable of giving signed informed consent/assent.
  • Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
  • Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
  • Participants capable of giving signed informed consent/assent.
  • Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
  • Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
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  • Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.
  • Participants with known V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF) molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
  • Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
  • Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
  • A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
  • Adequate organ function as defined in the protocol.
  • A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
  • Life expectancy of at least 12 weeks.

Who cannot join

  • Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
  • Docetaxel at any time.
  • Any of the investigational agents being tested in the current study.
  • Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
  • Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
  • Received greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
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  • Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
  • Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
  • Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
  • Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
  • Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
  • Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
  • Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
  • Prior allogeneic/autologous bone marrow or solid organ transplantation.
  • Receipt of any live vaccine within 30 days prior to first dose of study treatment.
  • Toxicity from previous anticancer treatment that includes:
  • Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
  • Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).
  • History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
  • Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
  • Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
  • History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
  • Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
  • Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
  • Symptomatic pericarditis.
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
  • Participants with known human immunodeficiency virus infection.
  • Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
  • Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
  • Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
  • Pregnant or lactating female participants.
  • Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
  • Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
  • Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
  • Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
  • Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

United States1 site

  • GSK Investigational Site

    Nashville, Tennessee, 37203

Other trials in United States

Canada1 site

  • GSK Investigational Site

    Brampton, Ontario, L6R3J7

Other trials in Canada

France1 site

  • GSK Investigational Site

    Bordeaux, 33076

Other trials in France

About this study

Official title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess the clinical activity of novel regimen (Feladilimab plus Ipilimumab) in participants with NSCLC.

Conditions
Neoplasms
Being tested
Feladilimab, Ipilimumab
Keywords
NSCLC, Feladilimab, Iplimumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FeladilimabDrug

    Feladilimab will be administered.

  • IpilimumabDrug

    Ipilimumab will be administered

Study groups in NCT06790303
Study groupRoleWhat they receive
Feladilimab plus IpilimumabExperimentalNot described
Receives: Drug: Feladilimab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

    Measured: Up to 29 weeks

  2. Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

    Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as febrile neutropenia as defined by CTCAE v5; Grade 4 neutropenia of >7 days in duration; Grade 4 anemia and Grade 3-4 thrombocytopenia with bleeding. Non-hematologic criteria, comprising Grade 4 toxicity; Grade 3 pneumonitis of any duration; Grade 3 toxicity that does not resolve to ≤Grade 1 or baseline within 3 days despite optimal supportive care; any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity Any other toxicity considered to be dose-limiting that occurs beyond four weeks was considered as DLT. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.

    Measured: Up to 21 days

  3. Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

    Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

    Measured: Baseline (Day 1) and up to 29 weeks

  4. Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

    Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

    Measured: Baseline (Day 1) and up to 29 weeks

  5. Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters

    Urine samples were collected for evaluation of urinalysis parameters using dipstick method. The dipstick test gave results in a semi-quantitative manner. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'Any increase', or 'no changes/decreased' values have been presented.

    Measured: Baseline (Day 1) and up to 29 weeks

  6. Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

    Urine samples were collected from participants to assess urine pH levels. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in urine pH were reported.

    Measured: Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)

  7. Part 1: Change From Baseline in Specific Gravity of Urine

    Urine samples were collected from participants to analyze urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in specific gravity of urine were reported.

    Measured: Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)

  8. Part 1: Number of Participants With AE Leading to Dose Modifications

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The number of participants who experienced AE leading to dose modifications were evaluated.

    Measured: Up to 29 weeks

  9. Part 2: Overall Survival

    OS is defined as the time from randomization until death due to any cause.

    Measured: Up to 29 weeks

Secondary outcomes (17)

  1. Part 1: Overall Response Rate (ORR)

    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).

    Measured: Up to 29 weeks

  2. Part 1: Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks. PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

    Measured: Up to 29 weeks

  3. Part 1: Maximum Concentration (Cmax) and Minimum Concentration (Cmin)

    Blood samples were collected for PK analysis.

    Measured: Up to 29 weeks

  4. Part 2: Milestone Survival Rate at 12 and 18 Months

    Milestone survival rate is the proportion of participants who are alive at a specific, predefined point in time after a certain event or diagnosis post treatment.

    Measured: At 12 and 18 months

  5. Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) Based on RECIST 1.1

    Complete Response [CR], Partial Response [PR], stable disease [SD], and progressive disease (PD) as assessed by the investigator per IMWG. CR defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm; PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

    Measured: Up to 29 weeks

  6. Part 2: Number of Participants With iRECIST Complete Response (iCR), iRECIST Partial Response (iPR), iRECIST Stable Disease (iSD), iRECIST Confirmed Progressive Disease (iCPD), and iRECIST Unconfirmed Progressive Disease (iUPD)

    Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was to be used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed.

    Measured: Up to 29 weeks

  7. Part 2: Number of Participants With PFS, ORR, DOR, and DCR

    PFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per RECIST criteria. ORR defined as the percentage of participants with a confirmed CR or PR at any time per RECIST criteria. DOR defined as the time from first documented evidence of CR or PR until disease progression or death, per RECIST criteria. DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks.

    Measured: Up to 29 weeks

  8. Part 2: Number of Participants With iPFS, iORR, and iDOR

    iPFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per iRECIST criteria. iORR defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iDOR defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.

    Measured: Up to 29 weeks

  9. Part 2: Number of Participants With AEs and SAEs

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Measured: Up to 29 weeks

  10. Part 2: Number of Participants With AESI

    Number of participants with AESI were planned to be evaluated.

    Measured: Up to 29 weeks

  11. Part 2: Number of Participants With AEs and SAEs Leading to Dose Modification

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Number of participants with AEs and SAEs leading to dose modification (delays/withdrawal) were planned to be evaluated.

    Measured: Up to 29 weeks

  12. Part 2: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters

    Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade.

    Measured: Up to 29 weeks

  13. Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters

    Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade.

    Measured: Up to 29 weeks

  14. Part 2: Number of Participants With Clinically Significant Changes in Vital Signs

    Vital signs were planned to be measured after 5 minutes of rest and taken in the same position throughout the study.

    Measured: Up to 29 weeks

  15. Part 2: Maximum Concentration (Cmax) and Minimum Concentration (Cmin)

    Blood samples were planned to be collected for PK analysis.

    Measured: Up to 29 weeks

  16. Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Feladilimab

    Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays.

    Measured: Up to 29 weeks

  17. Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Iplimumab

    Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays.

    Measured: Up to 29 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start4 Mar 2021
  3. Primary completion23 Sep 2021
  4. Study completion23 Sep 2021

Why it stopped: Due to low enrolment of participants

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790303
Sponsor's protocol ID
205801-002
Other IDs
2018-001316-29, 2018
Status last verified
May 2025
First submitted
22 Jan 2025
Last updated
4 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Feladilimab and Ipilimumab in people with Neoplasms, run by GlaxoSmithKline at 3 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 17 inclusion and 37 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 4 Jun 2025. 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, Canada, France. 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 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 4 Jun 2025). 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?

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 29 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790303.

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 4 Jun 2025.

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