Moderate to Severe Plaque PsoriasisPhase 3BE TOGETHERNCT06425549
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing bimekizumab and ustekinumab in people with Moderate to Severe Plaque Psoriasis, run by UCB Biopharma SRL at 42 sites in 10 countries.
Trial summary
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis (PSO). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- bimekizumab and ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 25 Jun 2024to 8 Nov 2030
- Phase
- Phase 3
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study participant must be 6 to <18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
- Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
- Study participant meets the following at both the Screening and Baseline Visits:
- Body surface area (BSA) affected by PSO ≥10%
- . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- . Psoriasis Area and Severity Index (PASI) score ≥12 OR
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- PASI score ≥10 plus at least 1 of the following:
- Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement
- Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling
- Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening
Who cannot join
- Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
- Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
- Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
- History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
- Study participant has previously received bimekizumab
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- Study participant has previously received ustekinumab
- Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
- Study participant has the presence of active suicidal ideation, or positive suicide behavior
- Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded
- Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
Germany10 sites
Ps0021 40740
Bad Bentheim
Ps0021 40515
Berlin
Ps0021 40138
Bonn
Ps0021 40356
Dresden
Ps0021 40023
Erlangen
Ps0021 40645
Frankfurt am Main
Ps0021 40758
Hamburg
Ps0021 40249
Kiel
Ps0021 40747
Mainz
Ps0021 40177
Münster
Poland8 sites
Ps0021 40741
Bialystok
Ps0021 40625
Lodz
Ps0021 40832
Lodz
Ps0021 40091
Nowa Sól
Ps0021 40737
Rzeszów
Ps0021 40743
Szczecin
Ps0021 40334
Wroclaw
Ps0021 40738
Wroclaw
United States7 sites
Ps0021 50201
Arlington, Texas, 76011
Ps0021 50084
Charleston, South Carolina, 29425
Ps0021 50355
Dallas, Texas, 75235
Ps0021 50162
Fountain Valley, California, 92708
Ps0021 50344
Indianapolis, Indiana, 46250
Ps0021 50161
Los Angeles, California, 90045
Ps0021 50196
Northridge, California, 91325
Italy4 sites
Ps0021 40440
Ancona, Località Torrette
Ps0021 40749
Catania
Ps0021 40085
Pisa
Ps0021 40567
Roma
Japan3 sites
Ps0021 20071
Nagasaki
Ps0021 20033
Nagoya
Ps0021 20337
Shimotsuga-gun
Spain3 sites
Ps0021 40750
Alicante
Ps0021 40751
Esplugues de Llobregat
Ps0021 40752
Granada
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis (PSO).
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- bimekizumab, ustekinumab, placebo
- Keywords
- bimekizumab, BKZ, ustekinumab, paediatric study participants, children, adolescents, Psoriasis, PSO, Plaque Psoriasis, Paediatric Psoriasis, Pediatric Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimekizumabDrug
Also called BKZ, UCB4940
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
ustekinumabDrug
Also called USTE
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
placeboDrug
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
| Study group | Role | What they receive |
|---|---|---|
| bimekizumab | Experimental | Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks). Receives: Drug: bimekizumab; Drug: placebo |
| ustekinumab | Active comparator | Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2. Receives: Drug: bimekizumab; Drug: ustekinumab; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index 90 (PASI90) response at Week 16
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Measured: Week 16
Investigator´s Global Assessment (IGA) 0/1 response at Week 16
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.
Measured: Week 16
Secondary outcomes (32)
PASI75 response at Week 4
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Measured: Week 4
PASI100 response at Week 16
A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Measured: Week 16
PASI90 response at Week 48
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Measured: Week 48
IGA 0/1 response at Week 48
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.
Measured: Week 48
PASI100 response at Week 48
A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Measured: Week 48
IGA 0 response at Week 16
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.
Measured: Week 16
IGA 0 response at Week 48
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.
Measured: Week 48
Incidence of treatment-emergent adverse events (TEAE)s
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of serious TEAEs
An serious adverse event (SAE) must meet 1 or more of the following criteria:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious.
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs leading to withdrawal from the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent withdrawal from study.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs predefined as safety topics of interest
Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions.
Measured: From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164)
Change from Baseline in vital signs (systolic blood pressure)
Blood pressure will be measured in millimeters of mercury (mmHg).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in vital signs (diastolic blood pressure)
Blood pressure will be measured in millimeters of mercury (mmHg).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in vital signs (pulse rate)
Pulse rate will be measured in beats per minute (beats/min).
Measured: From Baseline (Week 0) up to Week 48
Incidence of clinically significant physical examination findings reported as TEAEs
Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs.
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in height (growth assessment)
Growth assessment, as assessed by the change from Baseline in height.
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in weight (growth assessment)
Growth assessment, as assessed by the change from Baseline in weight.
Measured: From Baseline (Week 0) up to Week 48.
Change from Baseline in hematology parameters (platelet count)
Platelets will be measured in number of platelets per liter (10^9/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (erythrocytes)
Erythrocytes will be measured in number of red blood cells per liter (10^12/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (hemoglobin)
Hemoglobin will be measured in grams per liter (g/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (hematocrit)
Hematocrit will be measured in volume percentage (%) of red blood cells in blood.
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase)
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10^9/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium)
Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine)
Clinical chemistry parameters will be measured in micromols per liter (μmol/L).
Measured: From Baseline (Week 0) up to Week 48
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16
The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).
Measured: Week 16, compared to Baseline
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48
The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).
Measured: Week 48, compared to Baseline
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline
The CHAQ is a questionnaire designed to capture physical function in children and adolescents with juvenile rheumatoid arthritis. The CHAQ comprises 2 indices, Disability and Discomfort. The Disability Index assesses the degree of difficulty experienced over the past week across 30 items in the following 8 categories of the daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The Disability Index ranges from 0 (no disability) to 3 (maximum disability). Discomfort is determined by the presence of pain, as measured by a 100-mm visual analogue scale (VAS). In addition, a final global assessment item asks study participants to rate how they are doing by placing a mark on a 100 mm VAS.
Measured: Week 16, compared to Baseline
Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16
The Peak Pruritus NRS measures the worst level of itching in the past 24 hours on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch).
Measured: Week 16, compared to Baseline
Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
Plasma bimekizumab concentrations prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration
Measured: From Baseline to End of OLE Period (up to 144 weeks)
Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration
Measured: From Baseline to End of OLE Period (up to 144 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start25 Jun 2024
- Primary completion21 Aug 2028 (estimated)
- Study completion8 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 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
- NCT06425549
- Sponsor's protocol ID
- PS0021
- Other IDs
- U1111-1293-2383, 2023-503859-10-00, 2023
- Acronym
- BE TOGETHER
- Status last verified
- Sep 2026
- First submitted
- 2 May 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.