GlioblastomaPhase 1/2GLIOSTARNCT04573192
A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
A Phase 1/2 study testing L19TNF and Lomustine in people with Glioblastoma, run by Philogen S.p.A. at 15 sites in 4 countries.
Trial summary
Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- L19TNF and Lomustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 19 Feb 2021to Dec 2025
- 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, age ≥18.
- Patients with histologically confirmed glioblastoma at unequivocal first recurrence or progression according to RANO criteria.
- MGMT promotor methylation status known
- IDH wildtype.
- Patients may have undergone surgery for recurrence.
- For operated patients: The histological report must document glioblastoma recurrence and a new MRI will need to be done at 3-5 weeks after surgery (directly before study treatment start). Study treatment will need to start minimum 4 weeks to maximum 6 weeks after surgery.
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- Karnofsky Performance Status (KPS) ≥ 70%.
- Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- Female patients: female patients must be either documented not Women Of Childbearing Potential (WOCBP)* or must have a negative pregnancy test within 14 days of starting treatment. Additionally WOCBP must agree to use, from the screening to 6 months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
- Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
Who cannot join
- Prior treatment for glioblastoma at recurrence, except surgery.
- Surgical resection or biopsy of glioma within 4 weeks of the start of study treatment.
- Inability to undergo contrast-enhanced MRI.
- Prior treatment with lomustine.
- Known history of allergy to TNF or lomustine, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
- Absolute neutrophil count (ANC) < 1.5 x 10^9/L; platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl.
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- Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN.
- Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN).
- INR > 1.5 ULN.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.
- Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent, in the judgement of the investigator.
- History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- LVEF <55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded.
- Uncontrolled hypertension.
- Known arterial aneurism at high risk of rupture.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
- Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
- Anxiety ≥ CTCAE Grade 3.
- Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Known history of tuberculosis.
- Pregnancy or breast feeding.
- Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Subjects must have been either off corticosteroids, or on a stable or decreasing dose ≤ 4 mg daily dexamethasone (or equivalent) for 7 days prior to start of treatment. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.
- Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
- Serious, non-healing wound, ulcer, or bone fracture.
- Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).
- Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
- Any live vaccination within 4 weeks prior to treatment or plan to receive live vaccination during the study.
Trial locations and contacts
15 sites in 4 countries.
Marco Taras contact
15 sites in 4 countries
Italy5 sites, 5 recruiting
- Recruiting
Azienda USL di Bologna IRCCS delle Scienze Neurologiche di Bologna
Bologna
Enrico Franceschi
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Antonio Silvani
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova
Giuseppe Lombardi
- Not yet recruiting
Azienda Ospedaliero-Universitaria Senese Policlinico Le Scotte
Siena
Anna Maria Di Giacomo
- Not yet recruiting
AOU Città della Salute e della Scienza di Torino
Torino
Alessia Pellerino
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Bonn
Bonn
Ulrich Herrlinger
- Not yet recruiting
University Hospital Köln
Cologne
Norbert Galldiks
- Recruiting
Klinikum rechts der Isar
München
Meike Mitsdörffer
- Recruiting
Universitatsklinikum Tubingen
Tübingen
Ghazaleh Tabatabai
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital Neurologique Pierre Wertheimer
Bron
François Ducray
- Not yet recruiting
Hôpital Saint Louis
Paris
Stefania Cuzzubbo
- Not yet recruiting
Sorbonne University, AP-HP, Paris brain institute
Paris
Ahmed Idbaih
Switzerland3 sites, 3 recruiting
- Recruiting
Inselspital Universitätsklinik für Medizinische Onkologie Bern
Bern
Marc Wehrli
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
Andreas Hottinger
- Recruiting
Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum
Zurich, CH-8091
Tobias Weiss, MD, +41 44 255 11 11
About this study
Official title: A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed.
L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin. TNF not only induces apoptosis or necrosis in certain target cells, but also exerts inflammation and immunity. L19TNF selectively delivers TNF to the tumor site to spare normal tissues from undesired toxicity. Preclinical experiments with L19TNF have demonstrated tumor growth retardation in various mouse tumor models including models of glioma.
- Conditions
- Glioblastoma
- Being tested
- L19TNF, Lomustine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19TNFDrug
Also called onfekafusp alfa
Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine
LomustineDrug
Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 part: Dose Finding | Experimental | Phase I part:
Dose Finding Patients will be treated in cohorts according to a traditional 3+3 design with lomustine on Day 1 and L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26, of a 42-days cycle at different dose levels.
The RD will be confirmed following a traditional 3+3 design.
Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine
The dose of 13 ug/kg L19TNF will be declared the RD in case none of three or not more than one out of 6 patients experienced a DLT. Dose limiting toxicity will be assessed during the dose-escalation from Day 1 through Day 42 after the first administration of lomustine and study drug (Cycle 1). Not more than 2 patients might be treated simultaneously in Cycle 1. Receives: Drug: L19TNF; Drug: Lomustine |
| Phase II part: Signal Seeking | Experimental | 118 Patients will be randomized 1:1 and treated with either lomustine on day 1 and L19TNF on Days 1, 3 and 5, and on Days 22, 24, and 26 of a 42-days cycle at the RD established in the phase I part of the study or with lomustine on day 1 of a 42-days cycle.
* Treatment Arm 1: L19TNF plus Lomustine
* Treatment Arm 2: Lomustine Receives: Drug: L19TNF; Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Phase 1: DLT
Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0.
Measured: For Cohort 1 to Cohort 3 from Day 1 to Day 42 after the first administration of lomustine and study drug (Cycle 1)
For Phase 2: Overall Survival
Overall survival (OS) rate
Measured: From beginning of treatment to 12 months
Secondary outcomes (6)
PFS
Progression-free survival (PFS) based on iRANO criteria and a standardized MRI protocol will be assessed for all enrolled subjects.
Measured: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 52 weeks
PFS-rate at 6 months
Progression-free survival (PFS) based on iRANO criteria and a standardized MRI protocol will be assessed for all enrolled subjects
Measured: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 6 months
OS-rate at 12 months
Measured: From beginning of treatment to 12 months
Adverse Events (AE)
Safety of administration of L19TNF, through an assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Serious Adverse Events (AE)
Safety of administration of L19TNF, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Safety (DILI)
Evaluation of possible Drug Induce Liver Injury, caused by L19TNF, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start19 Feb 2021
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label phase I/II study in subjects with glioblastoma at first progression.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573192
- Sponsor's protocol ID
- PH-L19TNFCCNU-02/20
- Acronym
- GLIOSTAR
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2020
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Look T, Puca E, Buhler M, Kirschenbaum D, De Luca R, Stucchi R, Ravazza D, Di Nitto C, Roth P, Katzenelenbogen Y, Weiner A, Rindlisbacher L, Becher B, Amit I, Weller M, Neri D, Hemmerle T, Weiss T. Targeted delivery of tumor necrosis factor in combination with CCNU induces a T cell-dependent regression of glioblastoma. Sci Transl Med. 2023 May 24;15(697):eadf2281. doi: 10.1126/scitranslmed.adf2281. Epub 2023 May 24.
PubMed 37224228
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
- ClinicalTrials.gov ID
- NCT04573192
- Acronym / sponsor ID
- GLIOSTAR / PH-L19TNFCCNU-02/20
- Conditions
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Oct 2020 (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.
Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed.
L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin. TNF not only induces apoptosis or necrosis in certain target cells, but also exerts inflammation and immunity. L19TNF selectively delivers TNF to the tumor site to spare normal tissues from undesired toxicity. Preclinical experiments with L19TNF have demonstrated tumor growth retardation in various mouse tumor models including models of glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label phase I/II study in subjects with glioblastoma at first progression.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 part: Dose Finding | Experimental | Drug: L19TNF, Drug: LomustinePhase I part: Dose Finding Patients will be treated in cohorts according to a traditional 3+3 design with lomustine on Day 1 and L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26, of a 42-days cycle at different dose levels. The RD will be confirmed following a traditional 3+3 design. Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine The dose of 13 ug/kg L19TNF will be declared the RD in case none of three or not more than one out of 6 patients experienced a DLT. Dose limiting toxicity will be assessed during the dose-escalation from Day 1 through Day 42 after the first administration of lomustine and study drug (Cycle 1). Not more than 2 patients might be treated simultaneously in Cycle 1. |
| Phase II part: Signal Seeking | Experimental | Drug: L19TNF, Drug: Lomustine118 Patients will be randomized 1:1 and treated with either lomustine on day 1 and L19TNF on Days 1, 3 and 5, and on Days 22, 24, and 26 of a 42-days cycle at the RD established in the phase I part of the study or with lomustine on day 1 of a 42-days cycle. * Treatment Arm 1: L19TNF plus Lomustine * Treatment Arm 2: Lomustine |
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, age ≥18.
- Patients with histologically confirmed glioblastoma at unequivocal first recurrence or progression according to RANO criteria.
- MGMT promotor methylation status known
- IDH wildtype.
- Patients may have undergone surgery for recurrence.
Key exclusion criteria (32 listed)
- Prior treatment for glioblastoma at recurrence, except surgery.
- Surgical resection or biopsy of glioma within 4 weeks of the start of study treatment.
- Inability to undergo contrast-enhanced MRI.
- Prior treatment with lomustine.
- Known history of allergy to TNF or lomustine, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
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 |
|---|---|---|
| L19TNFAlso: onfekafusp alfaCohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine | Drug | Phase 1 part: Dose Finding, Phase II part: Signal Seeking |
| LomustineCohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine | Drug | Phase 1 part: Dose Finding, Phase II part: Signal Seeking |
Primary outcome
For Phase 1: DLT
Time frame: For Cohort 1 to Cohort 3 from Day 1 to Day 42 after the first administration of lomustine and study drug (Cycle 1)
Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0.
For Phase 2: Overall Survival
Time frame: From beginning of treatment to 12 months
Overall survival (OS) rate
6 secondary outcomes
PFS
Time frame: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 52 weeks
PFS-rate at 6 months
Time frame: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 6 months
OS-rate at 12 months
Time frame: From beginning of treatment to 12 months
Adverse Events (AE)
Time frame: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Serious Adverse Events (AE)
Time frame: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Safety (DILI)
Time frame: Throughout study completion for each patient, a maximum of 52 weeks for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 37224228Look T, Puca E, Buhler M, Kirschenbaum D, De Luca R, Stucchi R, Ravazza D, Di Nitto C, Roth P, Katzenelenbogen Y, Weiner A, Rindlisbacher L, Becher B, Amit I, Weller M, Neri D, Hemmerle T, Weiss T. Targeted delivery of tumor necrosis factor in combination with CCNU induces a T cell-dependent regression of glioblastoma. Sci Transl Med. 2023 May 24;15(697):eadf2281. doi: 10.1126/scitranslmed.adf2281. Epub 2023 May 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marco Taras contact
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L19TNF and Lomustine in people with Glioblastoma, run by Philogen S.p.A. at 15 sites in 4 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 32 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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 Italy, Germany, France, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Hemmerle, PhD (+390577017816, regulatory@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For Phase 1: DLT (time frame: For Cohort 1 to Cohort 3 from Day 1 to Day 42 after the first administration of lomustine and study drug (Cycle 1)). The study lists 2 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 NCT04573192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.