Sporadic Inclusion Body MyositisPhase 3NCT02573467
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
A Phase 3 study testing Bimagrumab in people with Sporadic Inclusion Body Myositis, run by Novartis Pharmaceuticals at 38 sites in 10 countries.
Trial summary
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. Read more about this study
- Who is it for?
- Ages 36 years and older
- Conditions the study is for
- Sporadic Inclusion Body Myositis
- What is being tested?
- Bimagrumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 2 Nov 2015to 13 Feb 2017
- Phase
- Phase 3
- 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 36 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed the core study
- Written informed consent must be obtained before any extension study assessment is performed.
- Able to communicate well with the investigator.
- Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
Who cannot join
- Women who are pregnant
- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose.
- Current use of prohibited treatments
- History of severe hypersensitivity reaction in the core study
- History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study
- Clinically significant abnormal liver function tests
- Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States12 sites
Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Columbus, Ohio, 43221
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Kansas City, Kansas, 66160
Novartis Investigative Site
Miami, Florida, 33101
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Phoenix, Arizona, 85028
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
Sacramento, California, 95817
Japan7 sites
Novartis Investigative Site
Kodaira, Tokyo, 187-8551
Novartis Investigative Site
Kumamoto, Kumamoto, 860-8556
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560
Novartis Investigative Site
Osaka, Osaka, 534-0021
Novartis Investigative Site
Sendai, Miyagi, 980-8574
Novartis Investigative Site
Tokushima, 770-8503
Novartis Investigative Site
Wakayama, Wakayama, 641-8510
Italy5 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Messina, ME, 98125
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Rome, Lazio, 00168
Australia3 sites
Novartis Investigative Site
Cauldfield, Victoria, 3162
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
St Leonards, New South Wales, 2065
Belgium3 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Edegem, Antwerpen, 2650
Novartis Investigative Site
Ghent, 9000
United Kingdom3 sites
Novartis Investigative Site
London, NW1 2BU
Novartis Investigative Site
Newcastle upon Tyne, NE4 5PL
Novartis Investigative Site
Salford, Manchester, M6 8HD
Netherlands2 sites
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Leiden, 2333 ZA
About this study
Official title: Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.
Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.
- Conditions
- Sporadic Inclusion Body Myositis
- Being tested
- Bimagrumab, Placebo
- Keywords
- sporadic inclusion body myositis,, muscle wasting,, extension study,, BYM338,, bimagrumab,
- Medical subject headings
- Myositis, Inclusion Body, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimagrumabDrug
Also called BYM338
BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
PlaceboDrug
Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
| Study group | Role | What they receive |
|---|---|---|
| BYM338/bimagrumab 10 mg/kg | Experimental | Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Receives: Drug: Bimagrumab |
| BYM338/bimagrumab 3 mg/kg | Experimental | Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Receives: Drug: Bimagrumab |
| BYM338/bimagrumab 1 mg/kg | Experimental | Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Receives: Drug: Bimagrumab |
| Placebo | Placebo comparator | Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.
Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
Measured: to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)
The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Measured: Core study baseline, weeks 52, 78, 104, and >=117
Secondary outcomes (6)
Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side
Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Measured: Core study baseline, week 52, week 78, week 104 and >=week 117
Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score
Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Measured: Core study baseline, week 52, week 78, week 104, and >=week 117
Estimated Annual Number of Falls Per Participant Within Treatment Group
Participants documented any fall occurrences in a paper diary during the study.
Measured: Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)
Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score
The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Measured: Core study baseline, week 52, week 78, week 104 and >=week 117
Change in Muscles of the Thigh
Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.
Measured: up to 1 year, up to 2 years
Number of Patients With Anti-BYM338 Antibodies
Investigated the development of immunogenicity against BYM338.
Measured: end of double-blind treatment (up to 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start2 Nov 2015
- Primary completion17 Aug 2016
- Study completion13 Feb 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sporadic Inclusion Body MyositisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573467
- Sponsor's protocol ID
- CBYM338B2203E1
- Other IDs
- 2015-001411-12, 2015
- Status last verified
- Feb 2018
- First submitted
- 9 Jul 2015
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tanko LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.
PubMed 33597289
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis
- ClinicalTrials.gov ID
- NCT02573467
- Acronym / sponsor ID
- CBYM338B2203E1
- Conditions
- Sporadic Inclusion Body Myositis
- Keywords
- sporadic inclusion body myositis,, muscle wasting,, extension study,, BYM338,, bimagrumab,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.
Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BYM338/bimagrumab 10 mg/kg | Experimental | Drug: BimagrumabParticipants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 3 mg/kg | Experimental | Drug: BimagrumabParticipants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 1 mg/kg | Experimental | Drug: BimagrumabParticipants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
Who may qualify
- Ages
- 36 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who completed the core study
- Written informed consent must be obtained before any extension study assessment is performed.
- Able to communicate well with the investigator.
- Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
Key exclusion criteria (7 listed)
- Women who are pregnant
- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose.
- Current use of prohibited treatments
- History of severe hypersensitivity reaction in the core study
- History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study
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 |
|---|---|---|
| BimagrumabAlso: BYM338BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. | Drug | BYM338/bimagrumab 1 mg/kg, BYM338/bimagrumab 10 mg/kg, BYM338/bimagrumab 3 mg/kg |
| PlaceboMatching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.
Time frame: to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)
Time frame: Core study baseline, weeks 52, 78, 104, and >=117
The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
6 secondary outcomes
Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side
Time frame: Core study baseline, week 52, week 78, week 104 and >=week 117
Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score
Time frame: Core study baseline, week 52, week 78, week 104, and >=week 117
Estimated Annual Number of Falls Per Participant Within Treatment Group
Time frame: Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)
Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score
Time frame: Core study baseline, week 52, week 78, week 104 and >=week 117
Change in Muscles of the Thigh
Time frame: up to 1 year, up to 2 years
Number of Patients With Anti-BYM338 Antibodies
Time frame: end of double-blind treatment (up to 8 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33597289Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tanko LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimagrumab in people with Sporadic Inclusion Body Myositis, run by Novartis Pharmaceuticals at 38 sites in 10 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 4 inclusion and 7 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Italy, Australia, Belgium and 5 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 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?
Yes. Results are posted in the registry (first posted 13 Mar 2018). 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?
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths. (time frame: to end of study (up to 14 months, including the 6-month treatment-free follow-up period)). 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 NCT02573467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.