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12 Vay736 Trials Near You
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 PowerIanalumab for Sjogren's Syndrome
Dayton, Ohio
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).
* The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months.
* The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years.
* The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up.
Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding.
Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study.
Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens:
* ianalumab 300 mg monthly or
* ianalumab 300 mg once every 3 months
Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study.
Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Live Vaccines, Others
600 Participants Needed
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Evans Syndrome, Coagulation Disorders, Others
Must Be Taking:Corticosteroids
225 Participants Needed
Ianalumab for Lupus
Dayton, Ohio
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Active Infections, Hepatitis B/C, HIV, Others
Must Be Taking:CS, Anti-malarials, DMARDs
406 Participants Needed
Ianalumab + Eltrombopag for Low Platelet Count
Dayton, Ohio
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Coagulation Disorders, Others
Must Be Taking:Eltrombopag
152 Participants Needed
Ianalumab for Autoimmune Hemolytic Anemia
Dayton, Ohio
This trial is testing ianalumab, a new medication, in patients with warm autoimmune hemolytic anemia who haven't responded to other treatments. The goal is to see if ianalumab can help increase and maintain their hemoglobin levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hematologic Disease, Other AIHA, Infections, Others
Must Not Be Taking:B-cell Depleting Therapy
90 Participants Needed
Ianalumab + Standard Therapy for Lupus Nephritis
Cincinnati, Ohio
This trial will test how well ianalumab injections work and how safe they are for adults with a type of kidney inflammation caused by lupus. The medication is given under the skin at regular intervals. It aims to reduce kidney inflammation by calming the immune system.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Renal Impairment, Transplant History, Active Infections, Others
Must Be Taking:Corticosteroids, MPA
420 Participants Needed
Ianalumab for Autoimmune Diseases
Middleburg Heights, Ohio
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Infections, Live Vaccines, Pregnancy, Others
140 Participants Needed
Ianalumab for Lupus
Lexington, Kentucky
This trial will test if ianalumab, an injection given regularly, is safe and effective for people with active systemic lupus erythematosus (SLE). The medication aims to calm down their overactive immune system to reduce inflammation and damage.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Active Infections, Hepatitis, Tuberculosis, Others
Must Be Taking:CS, Anti-malarials, DMARDs
280 Participants Needed
VAY736 for Advanced Cancer
Detroit, Michigan
This trial is testing a new medication called VAY736 to help adults with autoimmune hepatitis who haven't responded to or can't tolerate standard treatments. The goal is to see if VAY736 can reduce liver inflammation and improve liver function.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Decompensated Cirrhosis, Overlap Syndrome, Others
Must Not Be Taking:B-cell Depleting, Hepatotoxic Drugs
68 Participants Needed
Ianalumab for Lupus
Grand Blanc, Michigan
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Infections, Live Vaccines, Pregnancy, Others
550 Participants Needed
Ianalumab for Low Platelet Count
Washington, District of Columbia
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Secondary Thrombocytopenia, Neutrophils <1000/mm3, Others
Must Be Taking:Corticosteroids, TPO-RA
41 Participants Needed
Ianalumab for Systemic Sclerosis
Jackson, Tennessee
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Rheumatic Disease, Pulmonary Disease, Others
Must Not Be Taking:Cyclophosphamide, Biologics, Anti-fibrotics, Others
200 Participants Needed
Why Other Patients Applied
"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 changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"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
"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
"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
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Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials 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 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 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 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 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 ?
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 ?
Most recently, we added Ianalumab for Systemic Sclerosis, Ianalumab for Autoimmune Diseases and Ianalumab for Lupus to the Power online platform.Popular Searches
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