Giant Cell ArteritisPhase 2BIOVASNCT05168475
Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis
A Phase 2 study testing Rituximab, Infliximab and Tocilizumab in people with Giant Cell Arteritis and Takayasu Arteritis, run by Cambridge University Hospitals NHS Foundation Trust at 5 sites in United Kingdom.
Trial summary
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome
- What is being tested?
- Rituximab, Infliximab and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 14 Jul 2021to 29 Nov 2023
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged at least 5 years
- Have given, or their parent/ legal guardian aged ≥ 16 years old has given, written informed consent
- Diagnosis of NAAV (Appendix 4)
- Refractory disease defined by:
- Active disease, BVASv3-BIOVAS/ PVAS with ≥ 1 severe (new/worse) or ≥ 3 non-severe (new/worse) items despite 12 weeks of conventional therapy prior to screening visit OR
- Inability to reduce prednisolone below 15mg/day or (0.2mg/kg/day in case of children) without relapse in the 12 weeks prior to screening visit
Who cannot join
- Previous treatment failure/contraindication to ≥ 2 active trial IMPs
- Increase in the dose or frequency of background immunosuppressive (e.g. methotrexate) or anti-cytokine therapy within 30 days of screening visit
- Use of intravenous immunoglobulins within 30 days, or cyclophosphamide or lymphocyte depleting biologic (e.g. rituximab) within 6 months of screening visit
- Concomitant use of any biologic and/or anti-TNF agent other than the trial IMPs during the trial period
- Have an active systemic bacterial, viral or fungal infection, or tuberculosis
- Hepatitis B (HB) core antibody (Ab) or HB surface antigen positive or hepatitis C antibody positive or human immunodeficiency virus (HIV) antibody test positive
Show all 19Show fewer
- History of malignancy within five years prior to screening visit or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
- Pregnant or breastfeeding, or inability/unwillingness to use a highly effective method of contraceptive if a woman of childbearing potential (WOCBP;see section 11.9)
- Severe disease, which in the opinion of the physician prevents randomisation to placebo
- Recent or upcoming major surgery within 45 days of screening visit
- Leukocyte count < 3.5 x 109 cells/l, platelet count < 100 x 109 cells/l, neutrophil count of < 2 x 109 cells/l
- ALT or ALP > 3 times the upper limit of normal
- Symptomatic congestive heart failure (NYHA class III/IV) requiring prescription medication within 90 days of screening visit
- Demyelinating disorders
- History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk because of trial participation
- Administration of live or live attenuated vaccines within 45 days of screening
- Have received an investigational medicinal product (IMP) within 5 half-lives or 30 days prior to screening
- Diagnosis of adenosine deaminase type 2 (DADA2)
- Hypersensitivity to the active IMP substance or to any of the formulation excipients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Glasgow Royal Infirmary
Glasgow
Great Ormond Street Hospital NHS Foundation Trust
London
Guy's and St Thomas
London
East Kent Hospitals
Margate
About this study
Official title: Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects.
Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments.
The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)
Read the detailed description
The trial is a multi-centre, randomised, double-blind, placebo-controlled, modified-crossover design which will investigate three biologics, Infliximab, Rituximab, Tocilizumab, and placebos to each, in the treatment of refractory non-ANCA-associated Vasculitis (NAAV) in adults and children. Eligible patients are randomised to a sequence of up to 4 interventions (comprising 3 biologics and 1 placebo to one of the three biologics being studied). Patients remain on first intervention in their randomised sequence for up to 2 years, or until they are deemed to fail treatment or experience a severe disease relapse, at which point they will be switched to the next intervention in their randomised sequence. When a patient switches to the next intervention in their randomised sequence, they will again remain on treatment either until the end of treatment period or until they fail treatment or experience a severe disease relapse. Patients remain on the treatment period for a maximum of 2 years, or until they have failed/experienced severe relapses on every treatment in their randomised sequence, whichever is sooner. Patients will be assessed for disease activity and relapse every 120 days up to D720.
- Conditions
- Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome, Relapsing Polychondritis, Cryoglobulinemic Vasculitis, IgA Vasculitis
- Being tested
- Rituximab, Infliximab, Tocilizumab
- Keywords
- vasculitis
- Medical subject headings
- Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome, Polychondritis, Relapsing, Cryoglobulinemia, Familial Mixed, IgA Vasculitis, Polyarteritis Nodosa, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Hospital stock of rituximab used as intervention; biosimilars are allowed
InfliximabBiological
Hospital stock of infliximab is used in the trial; biosimilars are allowed
TocilizumabBiological
Hospital-supplied stock.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose). Receives: Biological: Infliximab; Biological: Tocilizumab |
| Infliximab | Active comparator | Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter. Receives: Biological: Rituximab; Biological: Tocilizumab |
| Tocilizumab | Active comparator | Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children < 30 kg. Receives: Biological: Rituximab; Biological: Infliximab |
| Placebo | Placebo comparator | Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Receives: Biological: Rituximab; Biological: Infliximab; Biological: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
Primary treatment failure is progressive disease (defined by appearance of ≥1 new/worse severe or ≥3 new/worse non-severe items) on Birmingham vasculitis activity score (BVAS) v3 modified for BIOVAS trial (BVASv3-BIOVAS) or paediatric vasculitis activity score (PVAS) within 120 days from the time of IMP commencement; or failure to achieve clinical response (see definitions below) by 120 days from the time of IMP commencement. In such cases, TTF will be recorded as zero. We report this as number of events that occurred. As arms reached the number of events to define a median, we are reporting it as number of events.
Measured: up to 720 days
Secondary outcomes (5)
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP
Proportion of participants achieving response at the 120 day evaluation time point after the start of each IMP.
The response status is defined by a BVAS v3-BIOVAS/ PVAS of ≤ one non-severe (no new/worse) item, prednisolone dose ≤ 50% of the dose at the start of the IMP treatment and ≤ 10mg/day (0.2 mg/kg/day for children, whichever is lower) and an ESR < 30mm/hr or CRP <10 mg/L
Measured: 120 days
Patients Achieving Response at Any 120 Day Timepoint
Proportion of participants achieving response at every 120 day evaluation time point defined by a BVAS v3-BIOVAS/ PVAS of ≤ 1 non-severe (no new/worse) item, prednisolone dose ≤ 50% of the dose at the start of the IMP treatment and ≤ 10mg/day (0.2 mg/kg/day for children, whichever is lower) and an ESR < 30mm/hr or CRP <10 mg/L
Measured: up to 720 days
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment
VDI/PVDI scores are collected from 11 different disease categories with each positive item scoring one mark. VDI/PVDI scores can either increase or stay the same at each measurement. All damage scores are carried forward to the next assessment. The minimum score is zero and the maximum score is 63. A low score indicates less damage and therefore a better outcome. A higher score indicates more damage and a worse outcome.
Due to the study design, participants were kept on each intervention until treatment failure and then moved to the next in their allocated sequence. Secondary outcome data were collected from the start of the first treatment without restarting collection at each crossover. Therefore, results are presented by treatment sequence. The number of participants analysed includes all participants who received the given intervention at any time during the study.
Measured: VDI/PVDI scores were collected every 120 days at each scheduled visit in the trial until the last assessment at day 720 at the end of trial. 120 days, 240 days, 360 days, 480 days, 600 days and 720 days
Physician's Global Assessment (PGA) (Likert Scale 0-10)
Physician's global assessment at every 120 day evaluation time point from the time of IMP commencement The Physician's global assessment (PGA) is a visual analogue scale from 0-10, where 0 is no disease activity (better outcome) and 10 is maximum disease activity (worse outcome).
PGA scores are collected every 120 days at each scheduled visit for each participant (unless a visit is unscheduled which could occur at any time in between the time points).
Due to the study design, participants were kept on each intervention until treatment failure and then moved to the next in their allocated sequence. Secondary outcome data were collected from the start of the first treatment without restarting collection at each crossover. Therefore, results are presented by treatment sequence. The number of participants analysed includes all participants who received the given intervention at any time during the study.
Measured: 120 days, 240 days, 360 days, 480 days, 600 days, 720 days
Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs)
Serious adverse events (SAEs) and adverse events of special interest (AESI) (where infection is considered an AESI)
Measured: up to 720 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start14 Jul 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: NIHR withdrawal of funding
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 Giant Cell ArteritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Modified-crossover; participants are randomised to a fixed sequence of 4 trial IMPs. Each sequence will consist of 3 active IMP treatments and a placebo. The order of the IMPs in each sequence will be randomly allocated (e.g. RTX-INF-TCZ-PBO or INF-PBO-RTX-TCZ) from a list of 24 permutations. Further, the placebo in each sequence will be randomly allocated to mirror the drug administration schedule of 1 of the active IMPs in order to maintain the blind resulting in 72 different possible permutations
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Jayne, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- David Jayne, Principal investigator, Cambridge University Hospitals NHS Foundation Trust/University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168475
- Sponsor's protocol ID
- BIOVAS
- Acronym
- BIOVAS
- Status last verified
- May 2025
- First submitted
- 9 Dec 2021
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children
- ClinicalTrials.gov ID
- NCT05168475
- Acronym / sponsor ID
- BIOVAS / BIOVAS
- Conditions
- Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome, Relapsing Polychondritis, Cryoglobulinemic Vasculitis, IgA Vasculitis
- Keywords
- vasculitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIHR withdrawal of funding
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects.
Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments.
The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)
Detailed description
The trial is a multi-centre, randomised, double-blind, placebo-controlled, modified-crossover design which will investigate three biologics, Infliximab, Rituximab, Tocilizumab, and placebos to each, in the treatment of refractory non-ANCA-associated Vasculitis (NAAV) in adults and children. Eligible patients are randomised to a sequence of up to 4 interventions (comprising 3 biologics and 1 placebo to one of the three biologics being studied). Patients remain on first intervention in their randomised sequence for up to 2 years, or until they are deemed to fail treatment or experience a severe disease relapse, at which point they will be switched to the next intervention in their randomised sequence. When a patient switches to the next intervention in their randomised sequence, they will again remain on treatment either until the end of treatment period or until they fail treatment or experience a severe disease relapse. Patients remain on the treatment period for a maximum of 2 years, or until they have failed/experienced severe relapses on every treatment in their randomised sequence, whichever is sooner. Patients will be assessed for disease activity and relapse every 120 days up to D720.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Modified-crossover; participants are randomised to a fixed sequence of 4 trial IMPs. Each sequence will consist of 3 active IMP treatments and a placebo. The order of the IMPs in each sequence will be randomly allocated (e.g. RTX-INF-TCZ-PBO or INF-PBO-RTX-TCZ) from a list of 24 permutations. Further, the placebo in each sequence will be randomly allocated to mirror the drug administration schedule of 1 of the active IMPs in order to maintain the blind resulting in 72 different possible permutations
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Biological: Infliximab, Biological: TocilizumabRituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose). |
| Infliximab | Active comparator | Biological: Rituximab, Biological: TocilizumabInfliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter. |
| Tocilizumab | Active comparator | Biological: Rituximab, Biological: InfliximabTocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children < 30 kg. |
| Placebo | Placebo comparator | Biological: Rituximab, Biological: Infliximab, Biological: TocilizumabPlacebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged at least 5 years
- Have given, or their parent/ legal guardian aged ≥ 16 years old has given, written informed consent
- Diagnosis of NAAV (Appendix 4)
- Refractory disease defined by:
Key exclusion criteria (19 listed)
- Previous treatment failure/contraindication to ≥ 2 active trial IMPs
- Increase in the dose or frequency of background immunosuppressive (e.g. methotrexate) or anti-cytokine therapy within 30 days of screening visit
- Use of intravenous immunoglobulins within 30 days, or cyclophosphamide or lymphocyte depleting biologic (e.g. rituximab) within 6 months of screening visit
- Concomitant use of any biologic and/or anti-TNF agent other than the trial IMPs during the trial period
- Have an active systemic bacterial, viral or fungal infection, or tuberculosis
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 |
|---|---|---|
| RituximabHospital stock of rituximab used as intervention; biosimilars are allowed | Biological | Infliximab, Placebo, Tocilizumab |
| InfliximabHospital stock of infliximab is used in the trial; biosimilars are allowed | Biological | Placebo, Rituximab, Tocilizumab |
| TocilizumabHospital-supplied stock. | Biological | Infliximab, Placebo, Rituximab |
Primary outcome
Treatment Failure
Time frame: up to 720 days
Primary treatment failure is progressive disease (defined by appearance of ≥1 new/worse severe or ≥3 new/worse non-severe items) on Birmingham vasculitis activity score (BVAS) v3 modified for BIOVAS trial (BVASv3-BIOVAS) or paediatric vasculitis activity score (PVAS) within 120 days from the time of IMP commencement; or failure to achieve clinical response (see definitions below) by 120 days from the time of IMP commencement. In such cases, TTF will be recorded as zero. We report this as number of events that occurred. As arms reached the number of events to define a median, we are reporting it as number of events.
5 secondary outcomes
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP
Time frame: 120 days
Patients Achieving Response at Any 120 Day Timepoint
Time frame: up to 720 days
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment
Time frame: VDI/PVDI scores were collected every 120 days at each scheduled visit in the trial until the last assessment at day 720 at the end of trial. 120 days, 240 days, 360 days, 480 days, 600 days and 720 days
Physician's Global Assessment (PGA) (Likert Scale 0-10)
Time frame: 120 days, 240 days, 360 days, 480 days, 600 days, 720 days
Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs)
Time frame: up to 720 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Giant Cell Arteritis
Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis
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 Jayne principal investigator
Cambridge University Hospitals NHS Foundation Trust/University of Cambridge
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Infliximab and Tocilizumab in people with Giant Cell Arteritis and Takayasu Arteritis, run by Cambridge University Hospitals NHS Foundation Trust at 5 sites in United Kingdom.
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 6 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: stopped early, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 17 Jun 2025). 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?
Treatment Failure (time frame: up to 720 days). 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 17 Jun 2025.