Stomach CancerPhase 3NCT04486651

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

A Phase 3 study testing Irinotecan Hydrochloride Injection and HX008 in people with Stomach Cancer, run by Taizhou Hanzhong biomedical co. LTD at 64 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stomach Cancer
What is being tested?: Irinotecan Hydrochloride Injection and HX008
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 560 participants
Where: 64 sitesChina
Study dates: 16 Sep 2020to 10 Aug 2023
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Understood and signed an informed consent form.
Age ≥ 18 and ≤ 75 years old, male or female.
Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
Willing to provide tissue for PD-L1 biomarker analysis.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.

Show all 9Show fewer

Life expectancy ≥ 3 months.
Has adequate organ function.
Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.

Who cannot join

Has squamous cell or undifferentiated gastric cancer.
Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Show all 17Show fewer

Has uncontrolled ascites, pleural effusion, or pericardial effusion.
Has active autoimmune disease that has required systemic treatment in past 2 years.
Has received a major surgery within 4 weeks prior to randomization.
Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
Has any serious and/or uncontrolled disease.
Has active viral infection.
Has received a live vaccine within 30 days prior to the first dose of trial treatment.
Has participated in other anticancer drug clinical trials within 4 weeks.
According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

64 sites in 1 country.

Jing Huang, MD contact

010-87788113

huangjingwg@163.com

City, postcode or hospital

Sites recruiting now only

64 sites in 1 country

China64 sites, 64 recruiting

Beijing ChaoYang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Guangyu An
Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jing Huang, MD, huangjingwg@163.com
Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Lin Zhao
Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bangwei Cao
Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Baoshan Cao
Recruiting
Peking University Internationale Hospital
Beijing, Beijing Municipality, 102206
Jun Liang
Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng
Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Wei Li
Not yet recruiting
The Second Xiangya Hospital of Cancer South University
Changsha, Hunan, 410000
Xianling Liu
Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Shan Zeng
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410200
Xianli Yin
Recruiting
Changzhou Cancer Hospital
Changzhou, Jiangsu, 213000
Yang Ling
Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Jin Lu
Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Weiqing Chen
Recruiting
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Chuan Jin
Not yet recruiting
Zhongshan People's Hospital
Guangzhou, Guangdong, 528403
Jianjun Xiao
Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, 510080
Sheng Ye
Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Yi Zheng
Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Liqin Lu
Recruiting
Sir Run Run Shaw Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, 310016
Hongming Pan
Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haijun Zhong
Recruiting
The affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Yuxian Bai
Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Yifu He
Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
Yueyin Pan
Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Zhendong Chen
Recruiting
The Affiliated People's Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Zhenping Wen
Recruiting
Hubei Cancer Hospital
Hubei, Wuhan, 430000
Xinjun Liang
Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
Weibo Wang
Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Bo Liu
Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650100
Qing Bi
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaojun Xiang
Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Yiye Wan
Recruiting
Guangxi Medical University Cancer Hospital
Naning, Guangxi, 530021
Zhihui Liu
Recruiting
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210000
Lingjun Zhu
Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009
Yang Yang
Recruiting
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu, 210009
Cailian Wang
Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226006
Lei Yang
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Jing Lv
Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200000
Hongxia Wang
Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Zan Shen
Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu
Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Jingdong Zhang
Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035
Shubin Wang
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518117
Chunxia Du
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Shengmian Li
Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Na Li
Recruiting
Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, 071000
Aimin Zang
Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Zhixiang Zhuang
Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Lu Wen
Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Diansheng Zhong
Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Wenran Wang
Recruiting
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000
Yong Tang
Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Zhiming Huang
Recruiting
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, 350000
Rongbo Lin
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Enxiao Li
Not yet recruiting
Fujian Cancer Hospital
Xiamen, Fujian, 350000
Rongbo Lin
Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yuan Yuan
Recruiting
Yangzhou FIrst People's Hospital
Yangzhou, Jiangsu, 225000
Jiandong Tong
Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Ping Sun
Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750001
Ping Chen
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Suxia Luo
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Qingxia Fan
Recruiting
The First Affiliated Hospital of Henan Science&Technology University
Zhengzhou, Henan, 471000
Xinshuai Wang
Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 540003
Shundong Cang
Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

Conditions: Stomach Cancer
Being tested: Irinotecan Hydrochloride Injection, HX008, Placebo
Medical subject headings: Stomach Neoplasms

What participants receive

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

Irinotecan Hydrochloride InjectionDrug
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
HX008Drug
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
PlaceboDrug
Administered as IV infusion on Day 1 of each 21-day cycle.

Study groups in NCT04486651
Study group	Role	What they receive
HX008 plus Irinotecan	Experimental	Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W. Receives: Drug: Irinotecan Hydrochloride Injection; Drug: HX008
Placebo plus Irinotecan	Placebo comparator	Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W. Receives: Drug: Irinotecan Hydrochloride Injection; Drug: Placebo

What is being measured

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

Overall Survival (OS) in All Participants
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
Measured: Up to approximately 36 months
Overall Survival (OS) in Participants With PD-L1 CPS≥1
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.
Measured: Up to approximately 36 months

Secondary outcomes (4)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Measured: Up to approximately 36 months
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Measured: Up to approximately 36 months
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Measured: Up to approximately 36 months

Timeline

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

16 Sep 202010 Aug 2023

First posted24 Jul 2020
Study start16 Sep 2020
Primary completion10 Aug 2023 (estimated)
Study completion10 Aug 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stomach CancerStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 560 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04486651
Sponsor's protocol ID: HX008-III-GC-01
Status last verified: Jan 2021
First submitted: 22 Jul 2020
Last updated: 28 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT04486651
Acronym / sponsor ID: HX008-III-GC-01
Conditions: Stomach Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 560 participants (estimated)
Lead sponsor: Taizhou Hanzhong biomedical co. LTDIndustry (pharma, biotech, devices)
Study start: 16 Sep 2020 (actual)
Primary completion: 10 Aug 2023 (estimated)
Study completion: 10 Aug 2023 (estimated)
First posted: 24 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HX008 plus Irinotecan	Experimental	Drug: Irinotecan Hydrochloride Injection, Drug: HX008Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Placebo plus Irinotecan	Placebo comparator	Drug: Irinotecan Hydrochloride Injection, Drug: PlaceboParticipants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Understood and signed an informed consent form.
Age ≥ 18 and ≤ 75 years old, male or female.
Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
Willing to provide tissue for PD-L1 biomarker analysis.

Key exclusion criteria (17 listed)

Has squamous cell or undifferentiated gastric cancer.
Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.

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
Irinotecan Hydrochloride Injection160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.	Drug	HX008 plus Irinotecan, Placebo plus Irinotecan
HX008200 mg administered as IV infusion on Day 1 of each 21-day cycle.	Drug	HX008 plus Irinotecan
PlaceboAdministered as IV infusion on Day 1 of each 21-day cycle.	Drug	Placebo plus Irinotecan

Primary outcome

Overall Survival (OS) in All Participants
Time frame: Up to approximately 36 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
Overall Survival (OS) in Participants With PD-L1 CPS≥1
Time frame: Up to approximately 36 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.

4 secondary outcomes

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 36 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 36 months
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 36 months
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Individual participant dataSharing planned: No

Related trials for Stomach Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

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.

Jing Huang, MD contact

010-87788113

huangjingwg@163.com

64 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan Hydrochloride Injection and HX008 in people with Stomach Cancer, run by Taizhou Hanzhong biomedical co. LTD at 64 sites in China.

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 9 inclusion and 17 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jing Huang, MD (010-87788113, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in All Participants (time frame: Up to approximately 36 months). 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 NCT04486651.

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 28 Jan 2021.