Lupus NephritisPhase 2ATLASNCT01499355
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
A Phase 2 study testing BIIB023, mycophenolate mofetil and oral corticosteroids in people with Lupus Nephritis, run by Biogen at 58 sites in 21 countries.
Trial summary
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- BIIB023, mycophenolate mofetil and oral corticosteroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 58 sitesin 21 countries
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
- Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) >1.0 mg/mg.
Who cannot join
- Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
- Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
- Subjects requiring dialysis within 12 months prior to Screening
- History of renal transplant
- Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/B-cell activating factor [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
58 sites in 21 countries.
58 sites in 21 countries
United States9 sites
Research Site
Boston, Massachusetts, 02118
Research Site
Chapel Hill, North Carolina, 27599-7025
Research Site
Columbus, Ohio, 43210
Research Site
El Paso, Texas, 79905
Research Site
Lake Success, New York, 11020
Research Site
Memphis, Tennessee, 38119
Research Site
Orlando, Florida, 32806
Research Site
Rochester, Minnesota
Research Site
Torrance, California, 90509
Argentina7 sites
Research Site
Capital Federal, Ciudad Autonoma Buenos Aires, C1015ABO
Research Site
Ciudad Autonoma Buenos Aires
Research Site
Córdoba, Córdoba Province, 5000
Research Site
La Plata, B1902COS
Research Site
San Juan, 5402DIL
Research Site
San Miguel de Tucumán, Tucumán Province, 4000
Research Site
San Miguel de Tucumán
Malaysia6 sites
Research Site
Ipoh, 30990
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, 43000
Research Site
Kuching, Sarawak, 93586
Research Site
Pulau Pinang, 10990
Research Site
Selangor Darul Ehsan, 41200
Mexico5 sites
Research Site
Cuauhtémoc, 06090
Research Site
León, 37000
Research Site
Mexico City, 14000
Research Site
Saltillo, Coahuila, 25000
Research Site
San Luis Potosí City, 78240
France4 sites
Research Site
Lille, Nord, 59037
Research Site
Paris, 75651
Research Site
Paris, 94010
Research Site
Pessac, Gironde, 33604
Colombia3 sites
Research Site
Barranquilla
Research Site
Bogotá
Research Site
Medellín
Brazil2 sites
Research Site
Cuiabá, Mato Grosso, 78048-902
Research Site
São Paulo, São Paulo, 04027-000
Philippines2 sites
Research Site
Manila, 1015
Research Site
Quezon City, 1102
Russia2 sites
Research Site
Moscow, 123182
Research Site
Saint Petersburg, 197022
South Korea2 sites
Research Site
Busan, 602-715
Research Site
Gyeonggi-do, 443-721
Thailand2 sites
Research Site
Bangkoknoi, Bangkok, 10700
Research Site
Patumwan, Bangkok, 10330
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
Read the detailed description
Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).
- Conditions
- Lupus Nephritis
- Being tested
- BIIB023, Placebo, mycophenolate mofetil, oral corticosteroids
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB023Biological
PlaceboBiological
Also called MMF, Cellcept
titrated to a target daily dose of 2 g (1 g twice daily)
oral corticosteroidsDrug
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF) Receives: Biological: Placebo; Drug: mycophenolate mofetil; Drug: oral corticosteroids |
| BIIB023 3 mg/kg | Experimental | BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF. Receives: Biological: BIIB023; Drug: mycophenolate mofetil; Drug: oral corticosteroids |
| BIIB023 20 mg/kg | Experimental | BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF. Receives: Biological: BIIB023; Drug: mycophenolate mofetil; Drug: oral corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52
Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).
Measured: Week 52
Secondary outcomes (8)
Percentage of Participants Who Achieve Complete Renal Response at Week 52
Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.
Measured: Week 52
Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52
Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.
Measured: Week 52
Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52
Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.
Measured: Baseline to Week 52
Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52
Measured: Baseline (Day 1), Week 52
Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52
Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).
Measured: Baseline, Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period
AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.
Measured: Day 1 to Week 12
Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period
AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.
Measured: Week 12 to Week 56
Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study
Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.
Measured: up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Results from pre-specified criteria did not demonstrate sufficient efficacy to warrant continuation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by BiogenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499355
- Sponsor's protocol ID
- 211LE201
- Other IDs
- 2011-002159-32
- Acronym
- ATLAS
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2011
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01499355
- Acronym / sponsor ID
- ATLAS / 211LE201
- Conditions
- Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results from pre-specified criteria did not demonstrate sufficient efficacy to warrant continuation of the study.
- Enrolment
- 276 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
Detailed description
Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo, Drug: mycophenolate mofetil, Drug: oral corticosteroidsPlacebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF) |
| BIIB023 3 mg/kg | Experimental | Biological: BIIB023, Drug: mycophenolate mofetil, Drug: oral corticosteroidsBIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF. |
| BIIB023 20 mg/kg | Experimental | Biological: BIIB023, Drug: mycophenolate mofetil, Drug: oral corticosteroidsBIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
- Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) >1.0 mg/mg.
Key exclusion criteria (6 listed)
- Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
- Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
- Subjects requiring dialysis within 12 months prior to Screening
- History of renal transplant
- Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/B-cell activating factor [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
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 |
|---|---|---|
| BIIB023 | Biological | BIIB023 20 mg/kg, BIIB023 3 mg/kg |
| Placebo | Biological | Placebo |
| mycophenolate mofetilAlso: MMF, Cellcepttitrated to a target daily dose of 2 g (1 g twice daily) | Drug | BIIB023 20 mg/kg, BIIB023 3 mg/kg, Placebo |
| oral corticosteroidsoral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day | Drug | BIIB023 20 mg/kg, BIIB023 3 mg/kg, Placebo |
Primary outcome
Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52
Time frame: Week 52
Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).
8 secondary outcomes
Percentage of Participants Who Achieve Complete Renal Response at Week 52
Time frame: Week 52
Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52
Time frame: Week 52
Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52
Time frame: Baseline to Week 52
Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52
Time frame: Baseline (Day 1), Week 52
Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52
Time frame: Baseline, Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period
Time frame: Day 1 to Week 12
Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period
Time frame: Week 12 to Week 56
Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study
Time frame: up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Biogen
58 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB023, mycophenolate mofetil and oral corticosteroids in people with Lupus Nephritis, run by Biogen at 58 sites in 21 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 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Argentina, Malaysia, Mexico, France and 16 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2017.