Ankylosing SpondylitisPhase 2BE AGILE 2NCT03355573
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
A Phase 2 study testing Bimekizumab in people with Ankylosing Spondylitis, run by UCB Biopharma SRL at 50 sites in 10 countries.
Trial summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 28 Nov 2017to 19 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed AS0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Who cannot join
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Poland13 sites
As0009 466
Bydgoszcz
As0009 453
Elblag
As0009 456
Elblag
As0009 455
Krakow
As0009 461
Lublin
As0009 467
Nowa Sól
As0009 451
Poznan
As0009 450
Torun
As0009 454
Warsaw
As0009 459
Warsaw
As0009 457
Wroclaw
As0009 460
Wroclaw
As0009 465
Wroclaw
Czechia8 sites
As0009 205
Brno
As0009 207
Olomouc
As0009 208
Pardubice
As0009 201
Prague
As0009 202
Prague
As0009 211
Prague
As0009 210
Praha 11 Chodov
As0009 203
Zlín
Russia7 sites
As0009 601
Moscow
As0009 604
Moscow
As0009 607
Moscow
As0009 600
Saint Petersburg
As0009 606
Saint Petersburg
As0009 608
Saint Petersburg
As0009 610
Saint Petersburg
Ukraine6 sites
As0009 700
Kyiv
As0009 707
Kyiv
As0009 705
Ternopil
As0009 708
Uzhhorod
As0009 706
Vinnytsia
As0009 704
Zaporizhzhya
Bulgaria4 sites
As0009 156
Dobrich
As0009 151
Plovdiv
As0009 155
Plovdiv
As0009 150
Rousse
United States3 sites
AS0009 6
Dallas, Texas, 75231
AS0009 1
Duncansville, Pennsylvania, 16635
As0009 30
Sarasota, Florida, 34239
Spain3 sites
As0009 801
A Coruña
As0009 800
Córdoba
As0009 803
Santiago de Compostela
About this study
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
- Conditions
- Ankylosing Spondylitis
- Being tested
- Bimekizumab
- Keywords
- Bimekizumab, Ankylosing Spondylitis, AS
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called UCB4940
Bimekizumab at a prespecified dose.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab | Experimental | Subjects will receive bimekizumab up to 4 years. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.
Measured: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Percentage of Participants With Serious Adverse Event (SAE) During the Study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Secondary outcomes (4)
Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.
Measured: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA) (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.
Measured: Baseline of AS0008, Week 48 (AS0009)
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008
The ASAS20 response was defined as relative improvements of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (BASFI) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.
Measured: Baseline of AS0008, Week 48 (AS0009)
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48
BASDAI is a validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening.
Measured: Baseline of AS0008, Week 48 (AS0009)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start28 Nov 2017
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
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 (6)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355573
- Sponsor's protocol ID
- AS0009
- Other IDs
- 2017-001002-15, 2017
- Acronym
- BE AGILE 2
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2017
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, Kivitz AJ, Poddubnyy D, Oortgiesen M, Vaux T, Fleurinck C, Shepherd-Smith J, de la Loge C, de Peyrecave N, van der Heijde D. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958. doi: 10.1002/art.42282. Epub 2022 Nov 7.
PubMed 35829672Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.
PubMed 35833532Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
PubMed 38977276Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
PubMed 41807031Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
PubMed 40194794Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.
PubMed 39890205
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT03355573
- Acronym / sponsor ID
- BE AGILE 2 / AS0009
- Conditions
- Ankylosing Spondylitis
- Keywords
- Bimekizumab, Ankylosing Spondylitis, AS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab | Experimental | Drug: BimekizumabSubjects will receive bimekizumab up to 4 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed AS0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Key exclusion criteria (3 listed)
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009
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 |
|---|---|---|
| BimekizumabAlso: UCB4940Bimekizumab at a prespecified dose. | Drug | Bimekizumab |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Time frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.
Percentage of Participants With Serious Adverse Event (SAE) During the Study
Time frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
4 secondary outcomes
Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study
Time frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008
Time frame: Baseline of AS0008, Week 48 (AS0009)
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008
Time frame: Baseline of AS0008, Week 48 (AS0009)
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48
Time frame: Baseline of AS0008, Week 48 (AS0009)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35829672Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, Kivitz AJ, Poddubnyy D, Oortgiesen M, Vaux T, Fleurinck C, Shepherd-Smith J, de la Loge C, de Peyrecave N, van der Heijde D. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958. doi: 10.1002/art.42282. Epub 2022 Nov 7.
- Results publication: PubMed 35833532Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.
- Results publication: PubMed 38977276Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
- Derived from this study: PubMed 41807031Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
- Derived from this study: PubMed 40194794Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
- Derived from this study: PubMed 39890205Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.
- Individual participant dataSharing planned: No
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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.
UCB Cares study director
001 844 599 2273
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimekizumab in people with Ankylosing Spondylitis, run by UCB Biopharma SRL at 50 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 3 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Poland, Czechia, Russia, Ukraine, Bulgaria 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. 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 13 Nov 2024). 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 With Treatment-emergent Adverse Events (TEAEs) During the Study (time frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)). 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 NCT03355573, which also lists 6 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 21 Nov 2024.