Search Results
Prevalence of Avoidant Restrictive Food Intake Disorder (ARFID) traits among children and adolescents with Food Allergy
This study looks at understanding eating behaviors and attitudes toward food in children/adolescents. More specifically the study's goal is to compare those with and without food allergies to gain a better understanding of a possible underlying factor towards certain behaviors. Children and their caregivers will complete a survey composed of a short section on the child's medical history regarding allergies followed with questions in commonly used clinical assessments.
Age 18 years or older
Intellectual disability preventing comprehension of questions
Child and/or caregiver unable to respond to English-language questionnaire
VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment
To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for Acute Respiratory Distress Syndrome (ARDS) and mortality.
shock
sepsis
pancreatitis
Vit. D deficiency
blood Calcium levels > 10.2
known kidney stone in past 1 year
Do Not Rescusitate orders (DNR)
prisoner
A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.
Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.
You will receive either study drug or placebo, undergo research-related tests and procedures, and questionnaires. You will need to visit the study center up to 18 times over a period of 15 months. You will have different tests and procedures throughout the study. The aim is to check on your health andsymptoms, check on your response to treatment and any side effects, and assess the study drug.This study will compare the study drug with either mepolizumab or benralizumab, known as the comparator medications. The effects of the drugs, both good and bad, will be compared. Study participants will be divided into 2 groups to receive:Study drug (once every 26 weeks) + placebo (once every 4 or 8 weeks) OR,Mepolizumab (once every 4 weeks) or benralizumab (once every 8 weeks) + placebo (once every 26 weeks).All participants will receive an active treatment. You will be assigned to receive either the study drug or comparator (mepolizumab or benralizumab) you were taking before the study. No participant previouslytaking mepolizumab will be assigned to benralizumab, and no participant previously taking benralizumab will be assigned to mepolizumab.
$183.00
Have a documented diagnosis of asthma for 2 or more years.
Receiving either mepolizumab or benralizumab for 12 or more months prior to screening.
A well-documented requirement for regular treatment with medium to high dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroid.
Current treatment with at least one additional controller medication, besides an inhaled corticosteroids.
Eosinophilic diseases
Pregnancy
Current or former smokers with a smoking history of 10 or more years.
Active COVID-19 infection
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
A phase 3 clinical trial to investigate the effectiveness and safety of a study drug in subjects in Idiopathic Pulmonary Fibrosis
You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.
Diagnosed with Idiopathic Pulmonary Fibrosis
Female participants who are pregnant or lactating
Receiving more than 10 L/min of oxygen supplementation at rest
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II
KONFIDENT-S is a trial to evaluate the long-term safety of KVD900 in patients who are 12 years of age or older with HAE type I or II. This trial will be conducted on an outpatient basis and includes in-clinic visits and televisits. The study will have multiple centers that will be participating in the study. Subjects will receive the study drug as this study does not include a placebo drug.
There will be 10 in-person visits and 14 televisits. Blood will be drawn at all of the in-person visits. The patient will need to complete a daily diary, and complete electronic questionnaires.
Have had at least 2 documented HAE attacks within 3 months prior to the enrollment visit.
Must have been on a stable dose and regimen with one of the protocol-allowed therapies for long-term prophylactic treatment for at least 6 months prior to the enrollment visit.
Male or Female
Must be 12 years of age and older.
Use of attenuated androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g. tranexamic acid) within 28 days prior to the Enrollment Visit.
Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
Any pregnant or breastfeeding patient.
A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic
We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.
Adult
Mentally impaired
Participants from Europe or European Union (EU)
Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey
The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.
Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.
Depends on study
Current tobacco user
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312(Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
This phase 3b study will evaluate long-term safety and efficacy ofCSL312 (also known as garadacimab) when administeredsubcutaneously (SC) once monthly for at least 12 months.Subjects entering CSL312_3002 will be from 3 sources:• Subjects who participated in Study CSL312_2001• Subjects who participated in Study CSL312_3001• CSL312-naïve HAE subjects who have not participated ineither of the above studies
During the study, you will be expected to self-administer the study medication by injection under the skin once a month, complete a daily diary, provide blood and urine samples, complete questionnaires, undergo physical exams and have your vital signs recorded.You will visit the site 12 times.
$80.00 plus travel reimbursement
Male or female
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening, as documented in the subject's medical record.
Aged ≥ 12 at the time of providing written informed consent or assent for minors
Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period.
Use of mAbs such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects’ use of estrogen-containing medications with systemic absorption (eg, oral contraceptive or hormonal replacement therapy within 4 weeks prior to the Run-in Period).
Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 3 months after receipt of the last dose of CSL312.
A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants with Hereditary Angioedema (The ALPHA-STAR Trial)
The main purpose of the study is to evaluate the safety and tolerability of an injection of the study drug in participants with Hereditary Angioedema. This study is open-label, which means that everyone in the study will receive the study drug and no participant will receive a placebo.
The study will last approximately for one year, with a total of approximately 11-16 study site visits. You will have your blood drawn at every study site visit, urine collected, pregnancy test if applicable, and receive study drug. You will also complete questionnaires and be contact weekly by the study site.
Documented diagnosis of HAE type I or II.
Experienced at least 4 HAE attacks within the 12 months prior to screening.
Negative pregnancy test at screening visit
Experience at least 2 HAE attacks during the Run-In period.
Active liver disease
History of drug or alcohol abuse in the 12 months prior to screening
Pregnant or breastfeeding
Use of medications prescribed for the prevention of HAE attacks prior to screening: lanadelumab within 90 days, berotralstat within 21 days, all other prophylactice therapies within 7 days.
Effects of antibiotic use on fecal microbiome and resistome
This study will investigate the changes in the human fecal microbiomes and resistomes in response to antibiotic treatment.
English speaking/reading
Books a medical appointment for upper respiratory tract infection
Patient participated in STUDY00012891 previously
Reason for medical visit is not upper respiratory tract infection
Patient is pregnant
Patient has a medical history that includes diagnosis of any intestinal related disease
A Phase 1/2, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of BMN 331, an Adeno-Associated Virus (AAV) Vector-Mediated Gene Transfer of Human SERPING1, in Subjects with Hereditary Angioedema (HAE) due to Human C1 Esterase Inhibitor (C1-INH) Deficiency
BMN 331 is an experimental drug that is being tested for the treatment of patients with HAE. This study is the first time BMN 331, which is a gene therapy, is being used in humans. BMN 331 is given only once during this research study and it is given as an infusion. The purpose of this study is to find out what effects, good and/or bad, the Study Drug has on you and your HAE.
You will have a total of 68 in person visits over 68 months where there will be blood drawn and other lab tests. You will have to travel to an off site location to receive the drug once and travel will be paid for by the sponsor of the trial.
Have a diagnosis of Hereditary Angioedema type I or type II
Willing to abstain from alcohol consumption for 52 weeks after the infusion
Females of childbearing potential must be willing to use contraception
Active cancer, autoimmune, hematologic, cardiac, or renal diseases which require regular treatment
Long term use of attenuated androgens
using immunosuppressants including corticosteroids
Translational Studies on Electronic Cigarette-derived Oxidants and their Long-term Cardiopulmonary Effects
This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD
You will be asked to reduce your cigarette smoking and use study-provided e-cigarettes for 3 months. You will be asked to attend 2 in-person visits at the Hershey Medical Center and participate in 4 telephone visits. Throughout the study you will be asked to complete questionnaires, have heart rate, blood pressure and pulse oximetry taken, electrocardiograms (ECGs), height and weight measured, provide medical history, perform pulmonary function tests, complete a 6-minute walk, have your exhaled carbon monoxide measured, provide urine specimen and have blood drawn.
mild-moderate COPD
current smoker
current use of other tobacco products
allergic to vegetable glycerin and/or propylene glycol
chronic drug and/or alcohol abuse
CC-93538-EE-001 – A PHASE 3, MULTI-CENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS
The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction and inflammation in subjects with Eosinophilic esophagitis (EoE).The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. The phase 3 program will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance, and Open-Label Extension study.
The participants are required to sign the consent form. If you decide to participate, you will be required to attend study visits, follow doctor's instructions and take the study drug as instructed. You will be required to complete electronic questionnsires, and tell you doctor about any health problems, symptoms and drugs that you are taking. There are two visits during screening, including EGD procedure with biopsies. All the procedures during screening are done to determine if you are qualified to participate in the study. If the screening tests show that you can take part in this study, a computer program will make the assignment of which study drug you are to receive. You will be assigned to start the study by receiving either active drug (360 mg of CC-93538), or placebo. Both active drug and placebo will be given weekly by subcutaneous injection.You will be asked to have blood test done for serum and for biomarkers at most of your visits (except week 20). Physical exam and pregnancy's tests will be done at screening visit, and every visit during the induction after week 4. the ECG test will be done at screening. Similarly, the blood work and pregnancy's tests will be done at every visit during the maintenance. urinalysis and physical exam will also be done at some visits in the maintenance. Your vital signs will be monitored throughout the study.
$750 induction, $565 Maintenance max
Histologic evidence of EoE
Symptoms of dysphagia
Previous therapy with PPI medications, intolerant or inadequate corticosteroid response, or steroid responders/naive
Must agree to maintain stable diet
Liver function impairment, structural abnormality of esophagus
Receiving concurrent treatment with another IP, or the same drug previously
Currently is succesfully treated for EoE with dietary modifications
Currently receiving corticosteroids
A 52-week, randomised, double-blind, placebo-controlled, parallel group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilicphenotype
Placebo-controlled efficacy and safety study of GSK3511294 in participants with severe asthma with an eosinophilic phenotype
There will be 19 in person visits over the course of 15 months where blood, EKGs, and other assessments will occur. You will receive the study drug every 26 weeks.
Have, or a high likelihood of having eosinophilic asthma
Have at least 2 asthma attacks requiring steroids in the past 12 months
Take daily inhaled corticosteroids
Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within the last 12 months
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within last 130 days prior
Current smoker or history of smoking
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis
This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis
-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
Saliva microRNA signatures in infants with wheezing associated respiratory illness
Wheezing is a common symptom of respiratory distress in infants and children. Infants who wheeze are at increased risk of being diagnosed with asthma, the most common chronic disease of childhood. This study aims to yield an objective measure of asthma risk using molecular markers obtained from saliva. Saliva miRNA (markers used in this study) levels will be measured using HiSeq technology. Refinement and validation of this measure in future large-scale studies could allow clinicians to accurately predict for families an infant’s risk of asthma and optimize medical management to prevent future hospitalizations.
If your child has a respiratory illness you will be asked to provide a saliva sample at one clinic visit. Six months after the initial encounter, you will be asked to do complete surveys designed to be done remotely at home.
$20.00
Presence of respiratory illness symptoms (cough, congestion, shortness of breath, runny nose)
Concurrent pneumonia (bacterial lung infection) at the time of enrollment
Bronchopulmonary dysplasia
Concurrent bacterial infection requiring antibiotics (e.g. otitis media)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety andEfficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 Clinical Trial to assess whether study drug DWN12088 is safe and effective in Patients With Idiopathic Pulmonary Fibrosis
During this study, you will be asked to come to in-person visits at the Hershey Medical Center over a period of 6 months During that time you will visit the study center 8 times and have various tests done including: signing informed consent, providing demographics, having a chest CT scan, reviewing medical history, having a physical exam done, having vital signs and an ECG taken, having bloodwork done, receiving study drug, receiving patient diaries, having study drug administered, performing lung function tests (spirometry, DLCO and 6-minute walk test), and completing questionnaires.
Diagnosed with idiopathic pulmonary fibrosis in the past 5 years
Able to walk 150 meters (492 feet) in 6 minutes
Lower respiratory tract infections requiring antibiotics in the last 4 weeks
Female participants who are pregnant or nursing
Use of investigational drugs for idiopathic pulmonary fibrosis in the last 4 weeks
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROL, PARALLEL GROUP STUDY TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND SAFETY OF INBRX-101 COMPARED TO PLASMA DERIVED ALPHA1-PROTEINASE INHIBITOR (A1PI) AUGMENTATION THERAPY IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA
Voluntary research study is to test INBRX-101 as an experimental drug to treat patients with alpha-1 antitrypsin deficiency. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in AATD emphysema patients when compared with current approved AATD therapy with A1PI.
You will visit the study site up to a total of 37 times for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion.
Unknown at this time
Confirmed diagnosis of alpha-1 antitrypsin deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Available to participate for duration of study and willingness to commit to all requirements of the study, including study visits
On waiting list for lung or liver transplant
Known or suspected diagnosis of type 1 diabetes or diagnosed uncontrolled type 2 diabetes
Active cancers or has a history of cancer within 5 years prior to screening
Females who are pregnant or breastfeeding or females of childbearing potential unwilling to practice highly effective contraception during the study
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety profile of barzolvolimab (CDX-0159) in patients with active EoE. The study will enroll approximately 60 patients.This study consists of four distinct phases lasting approximately a year. Each patient will receive 1 dose (2 injections) every 4 weeks. The participants will be required to sign the informed consent before any procedures are performed. If eligible for screening, they will need to have standard lab tests (blood and urine), EKG, pregnancy test if applicable, and tests for COVID-19. They will also be required to have EGD with biopsies done during the screening period and at weeks 12 and 28. If eligible to continue, the participants will be randomized on day 1, when they will receive their first treatment. They will be required to come back to the clinic in two weeks and four weeks after that. They will have to complete the e-diary questionnaires at home.
There will be ten in person visits, including screening, placebo-controlled treatment and active (open label) treatment. In addition, there are four follow up visits every 4 weeks. The participants must sign the informed consent. There are going to have vital signs checked at every visit. Some visits have a physical exam. There are blood tests, urine tests, ECG, and COVID -19 tests done. The participants will have EGD procedure with biopsies at screening, and at 12 and 28 weeks of treatment. There will be four study treatments administered in the clinic. The concomitant medications, and adverse events will be monitored and documented. Serum and urine pregnancy tests will be performed if applicable. Participants will be asked to complete electronic diary daily.
$75 per visit; you may receive travel reimbursement $50, and $50 meal compensation for visit 1, 2, 5, 7, and 9
Male or female, ≥ 18 years of age
Documented diagnosis of EoE by endoscopy
Must be symptomatic, with dysphagia twice a week
Must have been on a stable diet
Known active Helicobacter pylori infection
History of achalasia, Crohn’s disease, ulcerative colitis or celiac disease.
Esophageal dilation within 3 months prior to screening visit
Women who are pregnant or nursing.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps – The BiRCh Study
The purpose of this study is to find out if the experimental drug (brensocatib) improves symptoms of Chronic Rhinosinusitis Without Nasal Polyps and is safe. Study treatments include the study drug and mometasone furoate nasal spray (referred to as mometasone). The study drug will either be brensocatib (“active” drug that contains “real” drug) or placebo (looks like brensocatib but does not have any “real” drug in it). Mometasone will be taken by all participants throughout the study as routine care.
If you choose to participate in the study, the following main activities and procedures are required.•Complete questionnaires asking about your chronic rhinosinusitis symptoms and quality of life•Measure the amount of air you can breathe in through both sides of your nose (nasal airflow)•Electrocardiogram (ECG) and vital signs•Physical examination, including examinations of your mouth and skin•Provide blood and urine samples•Sinus computed tomography (CT) scan•Attend 9 study visits•Nasal endoscopy
Unknown at this time
Participants who have at least a 12-week history before Screening Visit of Chronic Rhinosinusitis without nasal polyps
Received a course of antibiotics or steroids to treat symptoms of Chronic Rhinosinusitis within 1 year or previous surgery for Chronic Rhinosinusitis
Diagnosis of Cystic Fibrosis or Primary Ciliary Dyskinesia
Scheduled sinus surgery at any time during the study or have had nasal surgery within 4 weeks of the first study visit
Participants with seasonal allergic rhinitis whose symptoms occur during the treatment period of the study
Current smoker
A Phase 3 Open-label Study to Evaluate the Safety,Pharmacokinetics, Pharmacodynamics, and Efficacy ofCSL312 (Garadacimab) in the Prophylactic Treatment ofHereditary Angioedema in Pediatric Subjects 2 to 11 Years ofAge
This is a voluntary research study that will help us see if the study medication, CSL312, is safe to use in children 2-11 years of age. The research study will also help to see if the medication works to prevent HAE attacks in this age group.
Attend 8 to 9 visits to the study center. Provide personal information about the child participating in the study and complete electronic diaries (eDiaries). The child participating in the study will have physical exams, vital signs, and blood/urine tests completed. The study medication will be given via injection.
Diagnosis of Hereditary Angioedema Type 1 or Type 2
Two or more Hereditary Angioedema attacks within the last 6 months or the 6 months before starting a preventative medication
Receiving any other experimental drug
Diagnosis of any other form of angioedema
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis
This is a phase 2 pharmaceutical sponsored clinical trial looking to evaluate the safety, tolerability, and efficacy of experimental drug TTI-101 in patients with Idiopathic Pulmonary Fibrosis (IPF).
Participants will attend 7 visits over 18-20 weeks at the Penn State Hershey Medical Center. Participants will receive study treatment for 12 weeks and the study doctor will continue to monitor you for 4 weeks. The study visits will involve completing some procedures and tests such as taking some blood and urine samples, taking vitals signs, physical exams, electrocardiograms (ECGs), questionnaires, breathing and walking tests, and a high-resolution computed tomography (HRCT) scan.
1050
Diagnosis of Idiopathic Pulmonary Fibrosis
Able to perform breathing tests
Receiving steroids >10mg/day
Other types of respiratory disease
Other uncontrolled, clinically relevant disease
No active cancer
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)
This is a phase 2b clinical trial looking to see if the drug PLN-74809 (bexotegrast) is effective and safe in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
If you choose to participate in this study and meet all the study entry requirements, you will be randomly assigned (by chance; like the flip of a coin) to receive either bexotegrast or placebo for the whole study. Neither your study doctor nor you will know whether you are receiving bexotegrast or placebo. You will be required to visit the Hershey Medical Center on at least 8 separate occasions over an approximate 58-week period. Procedures that will be performed during your visits include, but are not limited to, physical exams, blood tests, ECGs, completing questionnaires, lung functions tests, and CT scans.
1200
IPF diagnosis ≤ 7 years prior to screening
If on Ofev or Esbriet, must be on stable dose for >/= 12 weeks
FVC >/=45% predicted
DLCO >/= 30% predicted and </= 90% predicted
Obstructive lung disease
Current smokers
Active infection
IPF exacerbation within the last 6 months