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186 Clinical Trials near Galveston, TX
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerDato-DXd + Durvalumab for Breast Cancer
Webster, Texas
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disorders, Hepatitis, HIV, Others
Must Not Be Taking:Hormone Therapy
1902 Participants Needed
TAK-279 for Plaque Psoriasis
Webster, Texas
This trial is testing a new drug called TAK-279 to see if it can help people with moderate to severe plaque psoriasis. The study will compare TAK-279 to an existing treatment called apremilast, which is approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. The goal is to find out if TAK-279 can better reduce the skin problems associated with this condition.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Psoriasis, Recent Infection, Others
1108 Participants Needed
JNJ-77242113 for Plaque Psoriasis
Webster, Texas
This trial is testing a new medication called JNJ-77242113 to see if it helps people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. The study aims to find out if this new treatment can improve symptoms for those who have not responded well to other treatments.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Nonplaque Psoriasis, Severe Organ Disturbances, Others
Must Not Be Taking:Beta Blockers, Calcium Channel Blockers, Lithium
684 Participants Needed
JNJ-77242113 for Plaque Psoriasis
Webster, Texas
This trial is testing a new medication called JNJ-77242113 to see if it can help people with plaque psoriasis in hard-to-treat areas like the scalp, genital area, and palms/soles. The medication works by calming the immune system and slowing down skin cell growth. The goal is to find a more effective treatment for these challenging cases.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Nonplaque Psoriasis, Severe Organ Disturbances, Others
Must Not Be Taking:Beta Blockers, Calcium Channel Blockers, Lithium
311 Participants Needed
Risankizumab for Crohn's Disease
Webster, Texas
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
Must Not Be Taking:P19 Inhibitors
289 Participants Needed
MK-7240 for Ulcerative Colitis
Webster, Texas
This trial is testing tulisokibart, a new medication, to see if it can help people with moderately to severely active ulcerative colitis. The goal is to determine if tulisokibart can reduce inflammation and heal sores in the colon, leading to fewer symptoms. The study will compare different doses of tulisokibart over several months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Fulminant Colitis, Cancer, Others
1020 Participants Needed
Tralokinumab for Atopic Hand Eczema
Webster, Texas
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Contact Dermatitis, Phototherapy, Others
Must Not Be Taking:Immunosuppressives, Corticosteroids, Biologics, Others
235 Participants Needed
Ivonescimab + Pembrolizumab for Lung Cancer
Webster, Texas
This trial is testing two treatments for advanced lung cancer. One uses a new drug, Ivonescimab, and the other uses an existing drug, Pembrolizumab, both combined with chemotherapy. The goal is to see which treatment helps patients live longer and has fewer side effects.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Small Cell Lung Cancer, Genomic Alterations, Others
1080 Participants Needed
Upadacitinib for Hidradenitis Suppurativa
Webster, Texas
This trial is testing if a daily pill called upadacitinib can help people with a painful skin condition called hidradenitis suppurativa (HS) who haven't responded to usual treatments. The study will involve adults and teenagers and will check for safety and effectiveness over time. Participants will be randomly given either the medication or a non-active pill, and their progress will be monitored through periodic medical check-ups.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Active Skin Disease, Investigational Drugs, Others
Must Be Taking:Anti-TNF Biologics
1328 Participants Needed
Mirikizumab for Ulcerative Colitis
Webster, Texas
This trial is testing a medication called mirikizumab, which aims to reduce bowel urgency in adults with severe ulcerative colitis. The medication works by calming the immune system to reduce inflammation in the intestines. The study will last for several months and include multiple phases.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Ulcerative Proctitis, Cancer, Others
172 Participants Needed
Ruxolitinib Cream for Prurigo
Webster, Texas
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Dermatitis, Uncontrolled Thyroid, Others
Must Not Be Taking:Psoralen, Ultraviolet Therapy
204 Participants Needed
Abelacimab for Atrial Fibrillation
Webster, Texas
This trial is testing abelacimab, a medication aimed at preventing strokes and blood clots in people with Atrial Fibrillation. These patients are either unsuitable for or have chosen not to use common medications for thinning blood. Abelacimab works by reducing the blood's ability to form dangerous clots.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:65+
Key Eligibility Criteria
Disqualifiers:Acute Reversible AF, Recent Stroke, Others
Must Not Be Taking:Vitamin K Antagonists, DOACs
1900 Participants Needed
Oral Atogepant Tablets for Migraine
Friendswood, Texas
This trial is testing a medication called atogepant to treat migraines in children and teenagers aged 6 to 17. The study aims to see if atogepant is safe and effective for this age group. Atogepant helps by blocking a protein that triggers migraines, potentially reducing their occurrence and intensity. Atogepant is a newly approved oral medication for the prevention of episodic migraine in adults.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Chronic Migraine, Cluster Headache, Others
450 Participants Needed
Atogepant for Pediatric Migraine
Friendswood, Texas
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine.
Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.
Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.
There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Persistent Headache, Cluster Headache, Others
Must Be Taking:Atogepant
650 Participants Needed
Olezarsen for High Triglycerides
Webster, Texas
This trial is testing a medication called olezarsen to see if it is safe and can be tolerated by people with very high levels of blood fat (triglycerides). The study involves up to 700 participants who will take the medication for several months. The goal is to help reduce the fat in their blood and prevent serious health issues. Olezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:New Or Worsening Conditions, Others
Must Be Taking:Lipid-lowering Therapy
800 Participants Needed
Olezarsen for High Triglycerides
Webster, Texas
This trial is testing a new medication called olezarsen to see if it can lower blood fat levels in people with high triglycerides. The goal is to find out if olezarsen can effectively reduce triglycerides and help prevent related health issues. Olezarsen has been shown to significantly reduce apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:High HbA1c, Liver Enzymes, Low GFR, Others
Must Be Taking:Lipid-lowering Therapy
446 Participants Needed
SB-01 Injection for Degenerative Disc Disease
Webster, Texas
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Narcotic Use, Depression, Extreme Obesity, Others
417 Participants Needed
Imlunestrant for Early Breast Cancer
Webster, Texas
This trial is testing a new medication called imlunestrant to see if it works better than standard hormone treatments for certain breast cancer patients. The study focuses on patients with early-stage breast cancer that is estrogen receptor positive and HER2 negative, who have already been on hormone therapy for a period of time and are at high risk of their cancer returning. Imlunestrant works by blocking estrogen from helping cancer cells grow.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Other Cancer, Others
Must Be Taking:Endocrine Therapy
8000 Participants Needed
VX-147 for Kidney Disease
Webster, Texas
This trial is testing VX-147, a new drug, in adults and children with a genetic form of kidney disease. The drug aims to reduce the harmful effects of a specific protein in the kidneys.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:10 - 65
Key Eligibility Criteria
Disqualifiers:Transplant, Uncontrolled Hypertension, Diabetes, Others
466 Participants Needed
Centanafadine for ADHD
Friendswood, Texas
This trial aims to test the safety and tolerability of a daily ADHD medication in children and teens aged 4-17. The medication releases its effects slowly over the day to help manage symptoms consistently. HLD200 is a form of methylphenidate designed to provide benefits from morning until evening.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:4 - 18
Key Eligibility Criteria
Disqualifiers:Tourette's, Severe Anxiety, Psychosis, Autism, MDD, Others
680 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
Obicetrapib for Cardiovascular Disease
Friendswood, Texas
This trial is testing a new medication called Obicetrapib to help people with heart disease who still have high cholesterol despite taking strong treatments. The goal is to see if this medication can lower their risk of heart attacks, strokes, and other serious heart problems by reducing bad cholesterol levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Heart Failure, MI, Stroke, Hypertension, Others
Must Be Taking:Lipid-modifying Therapy
9541 Participants Needed
AK112 for Non-Small Cell Lung Cancer
Webster, Texas
A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Small Cell Carcinoma, Other Driver Mutations, Active Autoimmune, Others
Must Not Be Taking:Immunotherapy, Chinese Herbal
322 Participants Needed
Tozorakimab for COPD
Webster, Texas
This trial is testing injections of a drug called tozorakimab in adults with COPD who have frequent flare-ups. These patients are already on other inhaled treatments but still experience significant symptoms. The drug aims to reduce lung inflammation and prevent these flare-ups.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Asthma, Cardiovascular, Infection, Cancer, Others
Must Be Taking:Inhaled Therapy
1172 Participants Needed
Ubrogepant for Pediatric Migraine
Friendswood, Texas
This trial tests the safety and effectiveness of ubrogepant, a quick-relief migraine medication, in children aged 6-17 years. Ubrogepant works by blocking a protein that causes migraine pain. The study will involve regular check-ups over several months to ensure the treatment is safe and well-tolerated. Ubrogepant is an oral medication approved for the acute treatment of migraine in adults.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:ECG Abnormalities, Self-harm Risk, Others
Must Not Be Taking:Barbiturates
1200 Participants Needed
mRNA-1345 Vaccine for Respiratory Syncytial Virus
Friendswood, Texas
This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Guillain-Barré, Other Vaccines, Others
36814 Participants Needed
RSVpreF Vaccine for Bronchitis
Friendswood, Texas
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina.
Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States and Canada.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Metastatic Malignancy, End-stage Renal Disease, Unstable Cardiac Disease, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
38861 Participants Needed
Ziltivekimab for Cardiovascular Disease
Webster, Texas
This trial is testing whether ziltivekimab can lower the risk of heart attacks and strokes in people with heart disease, kidney disease, and inflammation. Participants will inject the medicine regularly. The study aims to see if reducing inflammation can help prevent serious heart problems.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Recent Heart Attack, Recent Stroke, Others
6200 Participants Needed
Resmetirom for Non-alcoholic Fatty Liver Disease
Webster, Texas
This trial is studying the safety and tolerability of Resmetirom, a pill taken regularly. It involves patients who are already using this medication. Resmetirom helps manage certain health conditions by targeting specific parts of the body and has shown to reduce liver fat in patients with non-alcoholic steatohepatitis (NASH) in previous studies.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Alcohol Use, Carcinomas, Chronic Liver Diseases, Autoimmune Disease, Others
1000 Participants Needed
Ovarian Suppression Therapy for Breast Cancer
Webster, Texas
This trial tests TOL2506, a treatment that stops ovaries from working, in premenopausal women and men with hormone-sensitive breast cancer. It aims to reduce hormone levels to slow down or stop cancer growth. TOL2506 is a treatment that stops ovaries from working, similar to other ovarian suppression methods.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 49
Key Eligibility Criteria
Disqualifiers:BMI, Breastfeeding, Life Expectancy, Others
Must Be Taking:Endocrine Therapy
250 Participants Needed
Litifilimab for Lupus
Webster, Texas
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:
\- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.
The study will be done as follows:
* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Be Taking:Antimalarials, Steroids, Immunosuppressants
548 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Galveston, TX pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Galveston, TX work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Galveston, TX 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Galveston, TX is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Galveston, TX several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Galveston, TX?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Galveston, TX?
Most recently, we added Sildenafil for Cancer-Related Cognitive Impairment, Mirena for Endometrial Hyperplasia and CD388 for Flu Prevention to the Power online platform.
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