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Non-Hodgkin LymphomaPhase 2NCT05283720

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

A Phase 2 study testing Epcoritamab, Lenalidomide and Ibrutinib in people with Non-Hodgkin Lymphoma, run by Genmab at 76 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
Epcoritamab, Lenalidomide and Ibrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
76 sitesin 13 countries
Study dates
14 Jun 2022to Nov 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of:
  • -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
  • DLBCL, not otherwise specified (NOS).
  • High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
  • Follicular lymphoma (FL) Grade 3B. OR
  • FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
Show all 11Show fewer
  • Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
  • Must have 1 or more measurable disease sites:
  • A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
  • At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

Who cannot join

  • Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  • Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.

Trial locations and contacts

76 sites in 13 countries.

76 sites in 13 countries

United States18 sites

  • Winship Cancer Institute of Emory University /ID# 242153

    Atlanta, Georgia, 30322

  • University of Maryland, Baltimore /ID# 242218

    Baltimore, Maryland, 21201

  • Novant Health Presbyterian Medical Center /ID# 242148

    Charlotte, North Carolina, 28204

  • East Carolina University - Brody School of Medicine /ID# 242506

    Greenville, North Carolina, 27834

  • Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144

    Kansas City, Missouri, 64114-4859

  • Thompson Cancer Survival Ctr /ID# 242150

    Knoxville, Tennessee, 37916

  • Northwell Health - Monter Cancer Center /ID# 245435

    Lake Success, New York, 11042

  • Joe Arrington Cancer Research /ID# 242226

    Lubbock, Texas, 79410

  • Yale University School of Medicine /ID# 242089

    New Haven, Connecticut, 06510

  • Icahn School of Medicine at Mount Sinai /ID# 242123

    New York, New York, 10029

  • Christiana Care Health Service /ID# 242301

    Newark, Delaware, 19713

  • Thomas Jefferson University Hospital /ID# 242077

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center /ID# 242106

    Philadelphia, Pennsylvania, 19111

  • Swedish Medical Center - Seattle /ID# 242269

    Seattle, Washington, 98104

  • MultiCare Institute for Research and Innovation /ID# 242127

    Tacoma, Washington, 98405

  • Tampa General Hospital /ID# 246748

    Tampa, Florida, 33606

  • The University of Arizona Cancer Center - North Campus /ID# 242219

    Tucson, Arizona, 85719

  • Novant Health Forsyth Medical Center /ID# 242198

    Winston-Salem, North Carolina, 27103

Other trials in United States

France10 sites

  • CHU Clermont-Ferrand /ID# 242344

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337

    Créteil, Paris, 94010

  • CHRU Lille - Hopital Claude Huriez /ID# 242335

    Lille, Nord, 59037

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345

    Nantes, Pays de la Loire Region, 44000

  • Hopital Saint-Louis /ID# 242336

    Paris, 75010

  • Hopital Pitie Salpetriere /ID# 242343

    Paris, Île-de-France Region, 75013

  • HCL - Hopital Lyon Sud /ID# 242349

    Pierre-Bénite, Rhone, 69495

  • CHU de Rennes - PONTCHAILLOU /ID# 242339

    Rennes, Brittany Region, 35000

  • IUCT Oncopole /ID# 242340

    Toulouse, Occitanie, 31059

  • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 242342

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Spain10 sites

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall de Hebron /ID# 243260

    Barcelona, 08035

  • Institut Catala dOncologia - LHospitalet /ID# 243261

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268

    Madrid, 28027

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 243264

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 243262

    Madrid, 28041

  • Clinica Universidad de Navarra - Pamplona /ID# 245031

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 243368

    Salamanca, 37711

  • Hospital Universitario Virgen del Rocio /ID# 243267

    Seville, 41013

  • Hospital Clinico Universitario de Valencia /ID# 243269

    Valencia, 46010

Other trials in Spain

Germany6 sites

  • Klinikum Augsburg /ID# 244523

    Augsburg, Bavaria, 86156

  • Universitaetsklinikum Leipzig /ID# 245513

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Giessen und Marburg /ID# 245308

    Marburg, Hesse, 35043

  • Universitaetsklinikum Regensburg /ID# 244517

    Regensburg, Bavaria, 93042

  • Universitaetsklinikum Ulm /ID# 244265

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg /ID# 245453

    Würzburg, Bavaria, 97080

Other trials in Germany

Netherlands5 sites

  • Vrije Universiteit Medisch Centrum /ID# 243319

    Amsterdam, North Holland, 1081 HV

  • Universitair Medisch Centrum Groningen /ID# 243318

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum /ID# 243316

    Leiden, South Holland, 2333 ZA

  • Maastricht Universitair Medisch Centrum /ID# 243317

    Maastricht, Limburg, 6229 HX

  • Duplicate_Erasmus Medisch Centrum /ID# 243315

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

South Korea5 sites

  • Seoul National University Bundang Hospital /ID# 242404

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 242402

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 242400

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 242401

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403

    Seoul, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Czechia4 sites

  • Fakultni Nemocnice Brno - Jihlavska /ID# 242683

    Brno, Brno-mesto, 625 00

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 241722

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava /ID# 242684

    Ostrava, Ostrava-mesto, 708 52

  • Vseobecna Fakultni nemocnice v Praze /ID# 242685

    Prague, Praha 17, 128 00

Other trials in Czechia

Hungary4 sites

  • Semmelweis Egyetem /ID# 242454

    Budapest, 1085

  • Orszagos Onkologiai Intezet /ID# 242458

    Budapest, 1122

  • Debreceni Egyetem-Klinikai Kozpont /ID# 242450

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935

    Kaposvár, Somogy County, 7400

Other trials in Hungary

Israel4 sites

  • Hadassah Medical Center-Hebrew University /ID# 243013

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 243014

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 243010

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 243012

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Japan3 sites

  • National Cancer Center Hospital /ID# 248995

    Chuo-ku, Tokyo, 104-0045

  • Kyoto University Hospital /ID# 248997

    Kyoto, Kyoto, 606-8507

  • Hokkaido University Hospital /ID# 248999

    Sapporo, Hokkaido, 060-8648

Other trials in Japan

Taiwan3 sites

  • China Medical University Hospital /ID# 242893

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 242894

    Tainan, 704

  • Taipei Veterans General Hosp /ID# 242892

    Taipei, 11217

Other trials in Taiwan

China2 sites

  • Beijing Cancer Hospital /ID# 252303

    Beijing, Beijing Municipality, 100142

  • Fudan University Shanghai Cancer Center /ID# 252292

    Shanghai, Shanghai Municipality, 200032

Other trials in China

Denmark2 sites

  • Aalborg University Hospital /ID# 242734

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshospital - Skejby /ID# 242670

    Aarhus, Central Jutland, 8200

Other trials in Denmark

About this study

Official title: Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally.

Read more

In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:

1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Being tested
Epcoritamab, Lenalidomide, Ibrutinib, Rituximab, Cyclophosphamide
Keywords
Non-Hodgkin Lymphoma, Epcoritamab, Lenalidomide, Ibrutinib, Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride (HCl], Prednisone (pola-R-CHP), ABBV-GMAB-3013, Cancer, Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,, Venclexta, ABT-199, GDC-0199, CC-99282, EPCORE, Pirtobrutinib, Mantle Cell Lymhoma
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Hairy Cell, Neoplasms, Recurrence, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • EpcoritamabDrug

    Also called ABBV-GMAB-3013;

    Subcutaneous Injection (SC)

  • LenalidomideDrug

    Oral; Capsule

  • IbrutinibDrug

    Also called Imbruvica

    Oral; Capsule

  • RituximabDrug

    Intravenous (IV); Injection

  • CyclophosphamideDrug

    IV; Injection

  • Doxorubicin Hydrochloride [HCl]Drug

    IV; Injection

  • PrednisoneDrug

    Oral; Tablet

  • Polatuzumab VedotinDrug

    IV; Injection

  • CC-99282Drug

    Oral; Capsule

Study groups in NCT05283720
Study groupRoleWhat they receive
Arm 1: Dose EscalationExperimentalParticipants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of epcoritamab in combination with lenalidomide in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Lenalidomide
Arm 2: Dose EscalationExperimentalParticipants with R/R DLBCL will receive escalating doses of epcoritamab in combination with ibrutinib and lenalidomide in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Lenalidomide; Drug: Ibrutinib
Arm 3: Dose EscalationExperimentalParticipants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride [HCl]; Drug: Prednisone; Drug: Polatuzumab Vedotin
Arm 4: Dose EscalationExperimentalParticipants with R/R DLBCL will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: CC-99282
Arm 5: Dose EscalationExperimentalParticipants with R/R follicular lymphoma (FL) will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: CC-99282
Arm 6A: Dose EscalationExperimentalParticipants with R/R mantle cell lymphoma (MCL) will receive escalating doses of epcoritamab in combination with ibrutinib in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Ibrutinib
Arm 1: Dose ExpansionExperimentalParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with lenalidomide in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Lenalidomide
Arm 2: Dose ExpansionExperimentalParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Lenalidomide; Drug: Ibrutinib
Arm 3: Dose ExpansionExperimentalParticipants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride [HCl]; Drug: Prednisone; Drug: Polatuzumab Vedotin
Arm 3B: Dose ExpansionExperimentalParticipants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP), in 21 day cycles,until unacceptable toxicity, withdrawal of consent, or completion of treatment.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride [HCl]; Drug: Prednisone; Drug: Polatuzumab Vedotin
Arm 4: Dose ExpansionExperimentalParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: CC-99282
Arm 5: Dose ExpansionExperimentalParticipants with R/R FL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: CC-99282
Arm 6: Dose ExpansionExperimentalParticipants with R/R MCL will receive the recommended dose of epcoritamab in combination with ibrutinib in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Ibrutinib

What is being measured

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

  1. Number of Participants with Dose-Limiting Toxicities (DLT)

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

    Measured: Up to Approximately 5 Years

Secondary outcomes (8)

  1. Best Overall Response (BOR) per Investigator

    BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.

    Measured: Up to Approximately 5 Years

  2. Duration of response (DOR) per Investigator

    DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.

    Measured: Up to Approximately 5 Years

  3. Number of Participants with Progression-free survival (PFS)

    PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to Approximately 5 Years

  4. Percentage of Participants with Complete Response (CR)

    CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

    Measured: Up to Approximately 5 Years

  5. Time-to-response (TTR)

    TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.

    Measured: Up to Approximately 5 Years

  6. Time to Next Antilymphoma Therapy (TTNT)

    Time to next antilymphoma therapy.

    Measured: Up to Approximately 5 Years

  7. Rate of Minimal Residual Disease (MRD) Negativity

    MRD is defined as the percentage of participants with assessment of the minimal residual disease.

    Measured: Up to Approximately 5 Years

  8. Overall Survival (OS)

    (OS) is defined as the time in months from first dose of epcoritamab to death from any cause.

    Measured: Up to Approximately 5 Years

Timeline

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

  1. First posted17 Mar 2022
  2. Study start14 Jun 2022
  3. Primary completionNov 2032 (estimated)
  4. Study completionNov 2032 (estimated)

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283720
Sponsor's protocol ID
M22-132
Other IDs
2023-505347-38, 2023-505347-38-00, 2023
Status last verified
Jul 2026
First submitted
9 Mar 2022
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab, Lenalidomide and Ibrutinib in people with Non-Hodgkin Lymphoma, run by Genmab at 76 sites in 13 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 11 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, France, Spain, Germany, Netherlands and 8 more countries. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

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?

Number of Participants with Dose-Limiting Toxicities (DLT) (time frame: Up to Approximately 5 Years). 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 NCT05283720.

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 7 Jul 2026.

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