Solid TumorsPhase 1NCT02827968
Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing KN035 in people with Solid Tumors, run by 3D Medicines (Sichuan) Co., Ltd. at 2 sites in United States.
Trial summary
This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- KN035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2017to Dec 2020
- Phase
- Phase 1
- 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
- Subjects must have a histological or cytological diagnosis of any type of carcinoma, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
- Subject is male or female and ≥ 18 years of age on day of signing informed consent.
- Subject must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Subject must have adequate hematologic and organ function. Note: If subject is receiving anticoagulants, then value must be within therapeutic range for the condition the subject is being treated for.
- Subject has voluntarily agreed to participate by giving written informed consent. If subject has agreed to a newly obtained biopsy of tumor (that can be biopsied based on Investigator's assessment). Tissue obtained for the biopsy must not be previously irradiated. No systemic antineoplastic therapy may be received by the subject between the time of the biopsy and the first administration of KN035.
- Female subject of childbearing potential has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible.
- Female subjects enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 120 days after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
- Male subjects must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy.
Who cannot join
- Subject who not recovered from the effects of any prior chemotherapy, radioactive, or biological cancer therapy prior to the first dose of study therapy (for prior cancer therapy drugs, a washout of 5 half-lives is required), or who has not recovered to CTCAE Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier. Subject who has had erlotinib, gefitinib, afatinib, or crizotinib within 1 week prior to the first dose of study therapy, or who has not recovered to CTCAE Grade 1 or better from the adverse events due to any of these drugs administered more than 1 week earlier.
- Subject is expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC).
- Subject had prior treatment targeting PD-L1 axis or CTLA 4. Subjects with prior treatment targeting PD-1 are allowed to enroll if the subject has a washout time of at least 4 weeks. Examples of such agents include (but are not limited to): BMS-936559 (MDX 1105); MPDL3280A (RG7446); and MEDI4736.
- Subject has a medical condition that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication. However, subjects using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg of prednisone) in the evening.
- Subject has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis).
- Subject has a known history of a hematologic malignancy, malignant primary brain tumor or malignant sarcoma, or of another malignant primary solid tumor, unless the subject has undergone potentially curative therapy with no evidence of that disease for 5 years.
Show all 19Show fewer
- Note: The time requirement does not apply to subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases and are off steroids for at least 7 days from first dose of KN035.
- Subject previously had a severe hypersensitivity reaction to treatment with another mAb.
- Subject has a history of pneumonitis or interstitial lung disease.
- Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism that is stable on hormone replacement will not be excluded from the study.
- Subject has an active infection requiring therapy.
- Subject is positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA (qualitative) is detected); subjects with negative hepatitis C antibody testing may not need RNA testing.
- Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Subject has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)), or a history of additional risk factors for torsade de pointes (TdP, e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or is using concomitant medications that prolong the QT/QTc interval.
- Subject is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- Subjects with symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- Subject is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Horizon Oncology Research, INC
Lafayette, Indiana, 47905
South Texas Accelerated Research Therapeutics
San Antonio, Texas, TX 78229
About this study
Official title: A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors
This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor.
Read the detailed description
The dose escalation will follow the traditional 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. Dosing schedule for cohorts 2 and above may change after interim PK analysis after Cohort 1 Cycle 1 to bi-weekly or other regimen based on elimination profile of KN035 to avoid excessive drug accumulation. Dose escalation will continue until identification of MTD, up to a maximum dose of 10 mg/kg. MTD is defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose-limiting toxicity (DLT) in Cycle 1.
- Conditions
- Solid Tumors
- Being tested
- KN035
- Keywords
- PDL-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN035Drug
KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.
| Study group | Role | What they receive |
|---|---|---|
| KN035 | Experimental | Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. Receives: Drug: KN035 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: From screening to up to cycle 1 (28 days)
Percentage of participants with adverse events (AEs), serious adverse events and AEs of special interest
Measured: From screening to up to 3 months after the last dose of study drug (up to approximately 2 years)
Secondary outcomes (7)
Serum Concentrations of KN035
Blood samples will be collected at Pre-dose, 6hrs,24 hrs,48hrs,96hrs after the end of the first injection of KN035, after injection of KN035 at Day 8, 15, 22 in first cycle and pre-dose and within 24hrs of following cycles(Cycle length = 28 days), and at the mandatory Safety Follow-up visits
Measured: From Pre-dose of the first dose to up to 3 months after the last dose of study drug (up to approximately 2 years)
Percentage of Participants with Best Overall Response as determined by Response Evaluation Criteria in Solid Tumours (RECIST) Version (v) 1.1
Measured: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Percentage of Participants with Objective Response as determined by RECIST v1.1
Measured: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Duration of Objective Response as determined by RECIST v1.1
Measured: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Progression Free Survival Duration as determined by RECIST v1.1
Measured: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Overall Survival Duration
Measured: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Percentage of participants with anti-therapeutic antibody (ATA)
Blood samples will be collected at Pre-dose of Cycle 1 and D1,8 of the following cycles.
Measured: From screening to up to 3 months after the last dose of study drug (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start13 Jan 2017
- Primary completionAug 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Liu, M.D., Study chair, 3D Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827968
- Sponsor's protocol ID
- KN035-US-001
- Status last verified
- Mar 2021
- First submitted
- 29 Jun 2016
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui C, Wang J, Wang C, Xu T, Qin L, Xiao S, Gong J, Song L, Liu D. Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2024 Sep 6;29(9):e1189-e1200. doi: 10.1093/oncolo/oyae102.
PubMed 38982653Papadopoulos KP, Harb W, Peer CJ, Hua Q, Xu S, Lu H, Lu N, He Y, Xu T, Dong R, Gong J, Liu D. First-in-Human Phase I Study of Envafolimab, a Novel Subcutaneous Single-Domain Anti-PD-L1 Antibody, in Patients with Advanced Solid Tumors. Oncologist. 2021 Sep;26(9):e1514-e1525. doi: 10.1002/onco.13817. Epub 2021 May 27.
PubMed 33973293
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02827968
- Acronym / sponsor ID
- KN035-US-001
- Conditions
- Solid Tumors
- Keywords
- PDL-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor.
Detailed description
The dose escalation will follow the traditional 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. Dosing schedule for cohorts 2 and above may change after interim PK analysis after Cohort 1 Cycle 1 to bi-weekly or other regimen based on elimination profile of KN035 to avoid excessive drug accumulation. Dose escalation will continue until identification of MTD, up to a maximum dose of 10 mg/kg. MTD is defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose-limiting toxicity (DLT) in Cycle 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN035 | Experimental | Drug: KN035Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must have a histological or cytological diagnosis of any type of carcinoma, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
- Subject is male or female and ≥ 18 years of age on day of signing informed consent.
- Subject must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Subject must have adequate hematologic and organ function. Note: If subject is receiving anticoagulants, then value must be within therapeutic range for the condition the subject is being treated for.
- Subject has voluntarily agreed to participate by giving written informed consent. If subject has agreed to a newly obtained biopsy of tumor (that can be biopsied based on Investigator's assessment). Tissue obtained for the biopsy must not be previously irradiated. No systemic antineoplastic therapy may be received by the subject between the time of the biopsy and the first administration of KN035.
Key exclusion criteria (19 listed)
- Subject who not recovered from the effects of any prior chemotherapy, radioactive, or biological cancer therapy prior to the first dose of study therapy (for prior cancer therapy drugs, a washout of 5 half-lives is required), or who has not recovered to CTCAE Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier. Subject who has had erlotinib, gefitinib, afatinib, or crizotinib within 1 week prior to the first dose of study therapy, or who has not recovered to CTCAE Grade 1 or better from the adverse events due to any of these drugs administered more than 1 week earlier.
- Subject is expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC).
- Subject had prior treatment targeting PD-L1 axis or CTLA 4. Subjects with prior treatment targeting PD-1 are allowed to enroll if the subject has a washout time of at least 4 weeks. Examples of such agents include (but are not limited to): BMS-936559 (MDX 1105); MPDL3280A (RG7446); and MEDI4736.
- Subject has a medical condition that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication. However, subjects using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg of prednisone) in the evening.
- Subject has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis).
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 |
|---|---|---|
| KN035KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution. | Drug | KN035 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: From screening to up to cycle 1 (28 days)
Percentage of participants with adverse events (AEs), serious adverse events and AEs of special interest
Time frame: From screening to up to 3 months after the last dose of study drug (up to approximately 2 years)
7 secondary outcomes
Serum Concentrations of KN035
Time frame: From Pre-dose of the first dose to up to 3 months after the last dose of study drug (up to approximately 2 years)
Percentage of Participants with Best Overall Response as determined by Response Evaluation Criteria in Solid Tumours (RECIST) Version (v) 1.1
Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Percentage of Participants with Objective Response as determined by RECIST v1.1
Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Duration of Objective Response as determined by RECIST v1.1
Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Progression Free Survival Duration as determined by RECIST v1.1
Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Overall Survival Duration
Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination by the Sponsor, whichever occurs first (up to approximately 2 years)
Percentage of participants with anti-therapeutic antibody (ATA)
Time frame: From screening to up to 3 months after the last dose of study drug (up to approximately 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 38982653Cui C, Wang J, Wang C, Xu T, Qin L, Xiao S, Gong J, Song L, Liu D. Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2024 Sep 6;29(9):e1189-e1200. doi: 10.1093/oncolo/oyae102.
- Derived from this study: PubMed 33973293Papadopoulos KP, Harb W, Peer CJ, Hua Q, Xu S, Lu H, Lu N, He Y, Xu T, Dong R, Gong J, Liu D. First-in-Human Phase I Study of Envafolimab, a Novel Subcutaneous Single-Domain Anti-PD-L1 Antibody, in Patients with Advanced Solid Tumors. Oncologist. 2021 Sep;26(9):e1514-e1525. doi: 10.1002/onco.13817. Epub 2021 May 27.
- Individual participant dataSharing planned: Undecided
Related trials for Solid Tumors
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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
David Liu, M.D. study chair
3D Medicines
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KN035 in people with Solid Tumors, run by 3D Medicines (Sichuan) Co., Ltd. at 2 sites in United States.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of dose limiting toxicities (DLTs) (time frame: From screening to up to cycle 1 (28 days)). 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 NCT02827968, which also lists 2 linked publications.
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 2 Jun 2021.