- RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA)
- RINVOQ is the first and only GRUNZOCHSE inhibitor approved for both active ankylosing spondylitis (AS) and nr-axSpA 1-3
- In a clinical study, RINVOQ delivered rapid plus meaningful disease control based on patients achieving ASAS40 vs . placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 14 1, 2
NORTH CHICAGO, Ill. , Oct. 21, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announces that the U. H. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the particular FDA approval of RINVOQ in April of this year with regard to adults along with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first plus only JAK inhibitor that is approved regarding both conditions. 1
Experience the full interactive Multichannel News Release here:
Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness, plus cannot be detected by x-ray. 5, 6 Nr-axSpA and AS are two sub-types of the broader condition called axial spondyloarthritis. Approximately five percent associated with patients with nr-axSpA will progress in order to AS after five years, and 19 percent will progress right after ten years. 7
“This latest FDA authorization of RINVOQ in dynamic nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options intended for this painful, chronic illness, ” said Thomas Hudson , M. D., senior vice president, research and development, chief scientific officer, AbbVie. “RINVOQ is now authorized to treat patients across the spectrum of axial spondyloarthritis. This further underscores AbbVie’s commitment to advancing the standards of care for patients living with these diseases. ”
The FDA acceptance decision will be supported simply by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of RINVOQ in adults with active nr-axSpA. Among patients that received RINVOQ 15 mg, nearly half achieved a good ASAS40* reaction, the primary endpoint, at week 14 compared to placebo (44. 9 percent versus 22. 3 percent respectively). one, 2 ASAS40 responses were observed as early as two weeks in nr-axSpA patients treated with RINVOQ. The safety profile in patients along with nr-axSpA treated with RINVOQ fifteen mg was consistent with the security profile within patients along with rheumatoid arthritis, psoriatic joint disease, and ankylosing spondylitis. one
“Many individuals coping with nr-axSpA continue to experience symptoms and are unable to control condition with current treatments. In the particular SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications, ” stated Atul Deodhar , Meters. D., professor of medicine and medical director of the Rheumatology Clinics for that Division associated with Arthritis plus Rheumatic Diseases at Oregon Health & Science University, and lead investigator of the SELECT-AXIS 2 nr-axSpA trial. “Today’s FDA approval offers an important new therapeutic choice for sufferers and their caregivers in order to help take control of their symptoms and disease. ”
“There are limited treatment options for people living with nr-axSpA, a condition that can pose many challenges for patients and significantly impact their own quality of life as their signs and symptoms persist despite treatment, ” said Cassie Shafer , chief executive officer, Spondylitis Association associated with America (SAA). “This authorization of RINVOQ is a tremendous step forward in providing our patient community with another option to help them reach their therapy goals, and to find relief. ”
This particular FDA acceptance marks the sixth indicator for RINVOQ in the United States across chronic immune-mediated illnesses, including four in rheumatology. just one
Additional study results include the particular following:
Improvement in nr-axSpA Signs & Symptoms at Week 14 1, two
In the SELECT-AXIS 2 nr-axSpA trial, patients receiving RINVOQ 15 magnesium experienced greater improvements in week fourteen compared to placebo in the individual components of the ASAS composite index, including total back again pain, patient global assessment of illness activity, morning stiffness, and physical function. Multiplicity-controlled endpoints included total back pain and Bath Ankylosing Spondylitis Disease Activity Index (BASFI).
- A significantly greater mean decrease through baseline inside Total Back Pain (-2. 91 change from baseline) in comparison to those receiving placebo (-2. 00). 2
- The significantly higher improvement within physical functionality (-2. 61 change from baseline) as assessed by mean differ from baseline in BASFI in comparison to individuals on placebo (-1. 47). two
*ASAS40 is a composite index that measures condition activity. 2 To achieve a good ASAS40 response, a patient’s disease activity must have improved by at least 40%, and also improved by two units (on a 0 to 10 scale) in a minimum of three of four disease areas evaluated, and the remaining area must not possess gotten worse, including back pain, patient global assessment of disease exercise, physical function, and early morning stiffness. 2
Other Health-Related Outcomes
Patients given RINVOQ 15 mg showed significant improvements in health-related quality associated with life while measured simply by Ankylosing Spondylitis Quality of Life (ASQoL) compared to placebo from Week 14.
- RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower ability to fight infections. Severe infections, some fatal, occurred, including tuberculosis (TB) plus infections caused by bacteria, fungi, or even viruses.
- Increased risk of death in people age 50+ with no less than 1 heart disease risk element.
- Cancer and immune system problems. Increased likelihood of a few cancers, which includes lymphoma plus skin. Current or past smokers have got higher risk to get lymphoma and lung cancer.
- Improved probability of major cardiovascular events such as heart attack, stroke, or death in people 50+ along with at the least 1 heart problems risk factor, especially in present or previous smokers.
- Blood clots, several fatal, in veins of the legs or lungs plus arteries. This occurred more often in individuals 50+ with at the very least one cardiovascular disease danger factor.
- Serious allergic reactions. Do not take if allergic in order to RINVOQ or even its ingredients.
- Tears within the stomach or intestines; changes in certain laboratory test outcomes.
For more information about RINVOQ, visit RINVOQ. com .
Patient Access & Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs in order to $5 per month for eligible, commercially insured patients. For those with restricted or no health insurance, AbbVie offers myAbbVie Assist, the patient assistance program that provides RINVOQ at no charge to all those who qualify. For more details, please visit AbbVie. com/myAbbVieAssist .
About SELECT-AXIS 2 trial program 4
SELECT-AXIS 2 was conducted as a master research protocol that contains two standalone studies along with randomization, data collection, analysis and reporting conducted independently. The Stage 3, randomized, placebo-controlled, double-blind studies are usually evaluating the particular efficacy plus safety associated with RINVOQ compared with placebo on reduction of signs and symptoms within adult participants with active axial spondyloarthritis (axSpA), including bDMARD-IR AS (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). More information on this particular trial can be found at https://www.clinicaltrials.gov/ (NCT04169373).
Within the medical trial, the primary endpoint was the particular percentage associated with subjects attaining an ASAS40 response after 14 several weeks of treatment with RINVOQ versus placebo.
Regarding RINVOQ ® (upadacitinib)
Discovered plus developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor which is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency pertaining to JAK-1 vs JAK-2, JAK-3, and TYK-2. 1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness plus safety is usually not currently known.
Inside the U. T., RINVOQ fifteen mg is approved for grownups with moderately to severely active rheumatoid arthritis who have had an inadequate reaction or intolerance to one or even more TNF blockers; adults with energetic psoriatic arthritis who have had an insufficient response or intolerance to one or even more TNF blockers; adults with active ankylosing spondylitis (AS) who have got recently had an inadequate response or even intolerance in order to one or maybe more tumor necrosis factor (TNF) blockers and adults along with active non-radiographic axial spondyloarthritis with goal signs of inflammation who else have recently had an inadequate response or intolerance to TNF blocker treatment. one RINVOQ 45 mg qualifies for use in adult patients with moderately to severely active ulcerative colitis who have recently had an insufficient response or intolerance in order to one or higher TNF blockers as a good induction therapy once daily for 8 weeks. The particular recommended dose of RINVOQ for maintenance treatment is definitely 15 mg once daily. A dosage of 30 mg as soon as daily might be considered for sufferers with refractory, severe or even extensive illness. Discontinue RINVOQ if an adequate response is not achieved with the thirty mg dose. Use the lowest effective dosage needed to maintain response. RINVOQ 15 magnesium once every day can also be initiated in adults plus children 12 years of age and older weighing not less than 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, which includes biologics or when make use of individuals therapies can be inadvisable. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased in order to 30 mg once everyday.
Phase a few trials associated with RINVOQ within rheumatoid joint disease, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s condition, ulcerative colitis, giant cell arteritis plus Takayasu arteritis are ongoing. four, 8-14
U. S i9000. Uses and Important Security Information About RINVOQ ® (upadacitinib) 1
RINVOQ is certainly a prescription medicine used to deal with:
- Adults with moderate to severe rheumatoid joint disease (RA) when 1 or even more medications called growth necrosis aspect (TNF) blockers have been used, plus did not work well or could not be tolerated.
- Adults with dynamic psoriatic arthritis (PsA) when 1 or even more medicines called TNF blockers have been used and did not work well or could not end up being tolerated.
- Adults along with moderate to severe ulcerative colitis (UC) when one if not more medicines called TNF blockers have got been utilized, and failed to work well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when 1 or a lot more medicines called TNF blockers happen to be used, and did not work well or could not be tolerated.
- Grown ups with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation whenever a TNF blocker medication has already been used plus would not function well or could not really be tolerated.
It is not known in case RINVOQ will be safe and effective in children along with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or even non-radiographic axial spondyloarthritis.
- Grownups and children 12 many years old plus older with moderate in order to severe eczema (atopic hautentzündung [AD]) that will could not respond to previous treatment and whose eczema is not really well managed with other pills or injections, including biologic medicines, or when the use of some other pills or even injections is just not recommended.
RINVOQ is safe and effective in kids 12 yrs of age plus older weighing as a minimum 88 pounds (40 kg) along with atopic dermatitis.
It is not known if RINVOQ is secure and effective within children under 12 years associated with age with atopic hautentzündung.
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to fight infections. Serious bacterial infections have happened while taking RINVOQ, which includes tuberculosis (TB) and infections caused by germs, fungi, or viruses that can spread throughout the particular body. Some people possess died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during therapy with RINVOQ. You should not start taking RINVOQ if a person have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your own treatment until your infection is controlled. You might be with higher risk of developing shingles (herpes zoster).
- Increased risk of dying in individuals 50 years plus older which have around 1 coronary disease (cardiovascular) danger factor.
- Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other malignancies, including skin cancers, can happen. Current or even past smokers are on the upper chances associated with certain cancer, including lymphoma and lung cancer. Follow your HCP’s advice about having your pores and skin checked meant for skin malignancy during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun plus use sunscreen.
- Increased risk of major cardiovascular (CV) occasions, like coronary heart attack, heart stroke, or loss of life, in people 5 decades and older who also have at a minimum 1 a heart attack (CV) risk factor, especially if you are a current or past smoker.
- Bloodstream clots. Blood clots inside the veins of the particular legs or lungs plus arteries may happen along with RINVOQ. This may be life-threatening and cause passing away. Blood clots in the veins associated with the legs and lungs have occurred more often that individuals who are 50 years and old and with more than one heart disease (CV) risk factor.
- Allergic reactions. Signs and symptoms such because rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or even throat, that will may lead to you are having an allergic reaction have got been seen in people getting RINVOQ. Some of these reactions had been serious. If any of these signs and symptoms occur during treatment along with RINVOQ, stop taking RINVOQ and get emergency healthcare help right away.
- Tears inside the stomach or intestines plus changes in certain lab tests. Your own HCP ought to do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your own RINVOQ therapy for a period of time if needed because associated with within these blood test results.
Do not get RINVOQ when you are allergic in order to upadacitinib or any of the particular ingredients in RINVOQ. See the Medication Guide or even Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP in the event that you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of a good infection for example:
- Fever, sweating, or even chills
- Shortness of breath
- Warm, red, or unpleasant skin or sores on your body
- Muscle aches
- Feeling tired
- Bloodstream in phlegm
- Diarrhea or even stomach discomfort
- Weight loss
- Burning when urinating or urinating more regularly than normal
- Have TB or have been within close contact with someone with TB.
- Are the current or even past smoker.
- Have had a heart attack, other center problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), bloodstream clots inside veins of the legs or even lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
- Have additional medical conditions including liver problems, low blood cell counts, diabetes, persistent lung disease, HIV, or a weak immune program.
- Live, have lived, or even have traveled to parts of the country, for instance the Ohio and Mississippi River valleys plus the Southwest, that improve your risk associated with getting certain kinds of fungal infections. In case you are usually unsure if you’ve been to these types of areas, ask your own HCP.
- Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ might harm your unborn baby. Your HCP will examine whether or not you are pregnant before a person start RINVOQ. You need to use efficient birth control (contraception) in order to avoid becoming pregnant during treatment with RINVOQ and designed for 4 weeks right after your last dose.
- Are usually breastfeeding or even intend to breastfeed. RINVOQ may pass into your breast milk. Do not really breastfeed throughout treatment with RINVOQ and for six days after your final dose.
Tell your HCP regarding all the particular medicines you take, which includes prescription plus over-the-counter medications, vitamins, and herbal supplements. RINVOQ along with other medicines may affect each other, causing side effects.
Especially tell your HCP if a person take:
- Medicines for yeast or bacterial infections
- Rifampicin or phenytoin
- Medicines that impact your defense mechanisms
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should We do or even tell the HCP AFTER starting RINVOQ?
- Inform your HCP right away in case you have got any symptoms of an infection. RINVOQ can make you more likely to obtain infections or make any infections you have worse
- Get emergency assist right away if you have any kind of symptoms of a heart attack or even stroke whilst taking RINVOQ, including:
- Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
- Severe tightness, pain, pressure, or even heaviness within your chest, throat, neck, or jaw
- Pain or discomfort in your own arms, back, neck, jaw, or belly
- Difficulty breathing along with or without chest discomfort
- Breaking out in a cold sweat
- Nausea or vomiting
- Feeling lightheaded
- Weakness in one part or even on one side of your body
- Slurred speech
- Tell your HCP immediately if you have any signs or symptoms associated with blood clots during therapy with RINVOQ, including:
- Pain or tenderness in one or both hip and legs
- Sudden unexplained chest or even upper back pain
- A suffocating feeling or difficulty breathing
- Tell your HCP correct away in case you have a fever or stomach-area pain that does not go aside, and a change in your own bowel habits.
What are usually the various other possible negative effects of RINVOQ?
Common side results include upper respiratory tract bacterial infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased bloodstream levels of creatine phosphokinase, sensitive reactions, swelling of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle discomfort, flu-like illness, rash, improved blood cholesterol levels, plus increased liver enzyme levels.
A separation or tear to the lining of the back part of the particular eye (retinal detachment) offers happened inside people with atopic dermatitis treated along with RINVOQ. Call your HCP straight away when you possess any sudden changes in your vision during treatment with RINVOQ.
These are not all the possible unwanted effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once the day with or without food. Usually do not split, crush, or chew the tablet. Take RINVOQ exactly like your HCP tells you in order to use this. RINVOQ is available in 15 magnesium, 30 mg, and forty five mg extended-release tablets.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged in order to report negative side effects associated with prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or even call 1-800-FDA-1088.
If a person are getting difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie. com/myAbbVieAssist to learn more.
Please click here for the Full Prescribing Information and Medicine Guide .
Globally, prescribing information varies; refer to the individual country product label just for complete info.
About AbbVie in Rheumatology
For more compared to 20 years, AbbVie has been dedicated to improving care for the purpose of people residing with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our own pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more individuals living along with rheumatic illnesses reach their particular treatment goals. To find out more, visit AbbVie in rheumatology.
AbbVie’s mission is to discover and deliver innovative medications that solve serious health issues today and address the particular medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives throughout several key therapeutic places: immunology, oncology, neuroscience, eye care, virology, and women’s health, in addition to products plus services across our Allergan Aesthetics portfolio. To learn more about AbbVie, please check out us at www.abbvie.com . Follow @abbvie upon Twitter, Facebook , LinkedIn or Instagram .
A few statements in this news release are, or might be regarded as, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe, inch “expect, inches “anticipate, ” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject in order to risks plus uncertainties that will may trigger actual results to differ materially from these indicated from the forward-looking claims. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits through AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, difficulties to intellectual property, difficulties inherent in the research plus development process, adverse litigation or government action, changes to laws and regulations applicable to the industry plus the effect of public health outbreaks, epidemics or pandemics, such since COVID-19. Extra information about the economic, competitive, governmental, technological and other factors that may influence AbbVie’s operations is set forth in Item 1A, “Risk Factors, ” associated with AbbVie’s 2021 Annual Report on Form 10-K, which usually has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Type 10-Q. AbbVie undertakes zero obligation to release publicly any kind of revisions in order to forward-looking statements as the result of subsequent activities or developments, except because required simply by law.
*Dr. Atul Deodhar , M. D., is a researcher/consultant for AbbVie.
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- A study comparing upadacitinib (ABT-494) to placebo and also to adalimumab in grown-ups along with rheumatoid arthritis that are on a stable dosage of methotrexate and that have an inadequate response to methotrexate (SELECT-COMPARE). ClinicalTrials. gov identifier: NCT02629159. Accessed October 21, 2022 . https://www.clinicaltrials.gov/ct2/show/NCT02629159
- The Study to Evaluate the Protection and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials. gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Utilized on Oct 21, 2022 .
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 to the Induction associated with Symptomatic and Endoscopic Remission in Topics With Reasonably to Seriously Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant in order to Immunomodulators or Anti-TNF Treatment. ClinicalTrials. gov. Offered at: https://clinicaltrials.gov/ct2/show/NCT02365649 . Seen on October 21, 2022 .
- The Study to judge the Basic safety and Effectiveness of Upadacitinib in Individuals With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials. gov. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Reached: October 21, 2022 .
- A Study Comparing Upadacitinib (ABT-494) to Placebo plus to Adalimumab in Participants With Psoriatic Arthritis That have an Inadequate Response in order to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT – PsA 1). ClinicalTrials. gov. Accessible at: https://clinicaltrials.gov/ct2/show/NCT03104400 . Used on Oct 21, 2022 .
- Research to Compare Safety and Efficacy of Upadacitinib to Dupilumab within Adult Individuals With Moderate to Serious Atopic Dermatitis (Heads Up). ClinicalTrials. gov. Offered at: https://clinicaltrials.gov/ct2/show/NCT03738397 . Contacted: October twenty one, 2022 .
- A Research to gauge the Efficacy plus Safety associated with Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials. gov. Offered by https://clinicaltrials.gov/ct2/show/record/NCT04161898 . Accessed: October 21, 2022 .