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27 Myositis Trials
Power is an online platform that helps thousands of Myositis 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.
Nipocalimab for Myositis
Columbus, OhioThis trial is testing Nipocalimab, a medicine that blocks harmful antibodies, in patients with muscle weakness and other issues due to idiopathic inflammatory myopathies (IIM). The goal is to see if it can improve their condition by lowering harmful antibody levels.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
36 Participants Needed
ABC008 for Inclusion Body Myositis
Columbus, OhioThis trial is testing a new drug called ABC008 to help people with Inclusion Body Myositis, a muscle disease with few treatment options. The drug may work by affecting certain immune cells. Researchers will check if it improves muscle strength and quality of life.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40+
Sex:All
231 Participants Needed
Efgartigimod for Myositis
Columbus, OhioThis trial is testing an injectable medication called efgartigimod PH20 SC in people with certain muscle inflammation diseases. The goal is to see if it helps improve their condition by lowering harmful proteins in their blood. The study focuses on patients with specific subtypes of these diseases who often don't respond well to usual treatments. Efgartigimod was developed for autoimmune diseases and has been approved for treating a specific muscle condition in adults.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Infection, Autoimmune Disease, Malignancy, Others
240 Participants Needed
CC-97540 for Severe Refractory Lupus
Columbus, OhioThis trial is testing a new drug called CC-97540. It aims to help people with severe autoimmune diseases that don't get better with regular treatments. Researchers want to see if the drug is safe, how it moves through the body, and if it can improve patients' health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Drug-induced SLE, Multiple Sclerosis, Psoriasis, Others
129 Participants Needed
Daxdilimab for Inflammatory Myositis
Columbus, OhioThis trial is testing daxdilimab, a new medicine, to see if it can help patients with specific muscle and skin diseases by reducing inflammation and symptoms. The study focuses on patients with dermatomyositis or anti-synthetase inflammatory myositis.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
12 Participants Needed
Empasiprubart for Dermatomyositis
Dayton, OhioThis study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).
The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Malignancy, Infection, Others
42 Participants Needed
PF-06823859 for Myositis
Cleveland, OhioThis trial is testing a new medicine called PF-06823859 for adults with muscle inflammation diseases DM and PM. The goal is to see if it can safely reduce muscle inflammation and weakness.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cancer, Infections, Neurological Disorders, Others
Must Be Taking:Corticosteroids, Immunosuppressants
270 Participants Needed
Anifrolumab for Myositis
Cleveland, OhioThe purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Inclusion Body Myositis, Cancer, HIV, Others
Must Be Taking:Prednisone, Others
240 Participants Needed
Nintedanib for Interstitial Lung Disease
Cleveland, OhioThis trial tests nintedanib, a drug that slows lung damage, in patients with myositis-associated interstitial lung disease. It works by blocking proteins that cause lung inflammation and scarring. Nintedanib has been approved for treating certain lung diseases and has shown positive results in various conditions.
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
70 Participants Needed
Efgartigimod SC for Myositis
Pittsburgh, PennsylvaniaThis trial aims to check the safety and effectiveness of an injectable medication called efgartigimod PH20 SC in adults with muscle inflammation who participated in an earlier phase. The medication works by reducing harmful proteins that cause muscle problems.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18+
Sex:All
240 Participants Needed
M5049 for Myositis
Pittsburgh, PennsylvaniaThis trial is testing a pill called M5049 for people with muscle diseases known as dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle inflammation and weakness. The pill aims to reduce inflammation and improve muscle strength over several months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Inclusion Body Myositis, Cancer, Others
Must Be Taking:Corticosteroids, Immunosuppressives
40 Participants Needed
Dazukibart for Myositis
Beckley, West VirginiaThe purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \[DM\] or polymyositis \[PM\]).
Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.
DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.
These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.
This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.
The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.
There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Infections, Others
Must Not Be Taking:Prohibited Medications
211 Participants Needed
CNTY-101 for Lupus
Chicago, IllinoisCALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (DcSSc).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:17+
Sex:All
Key Eligibility Criteria
Disqualifiers:Hemodialysis, CNS Disease, Transplant, Others
48 Participants Needed
CTX112 for Lupus
Chicago, IllinoisThis is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
80 Participants Needed
CABA-201 for Inflammatory Myopathies
Chicago, IllinoisRESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:6 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Organ Transplant, Others
24 Participants Needed
AZD5492 for Lupus and Myositis
Hamilton, OntarioThe purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM.
Study details include:
• The study duration will be a minimum of 180 days in addition to the screening period.
Additional follow-up visits may be required up to 12 months from study start.
* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2).
* Study visits will occur at:
Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
50 Participants Needed
INCB000928 for Stone Man Syndrome
Toronto, OntarioThis trial is testing a new drug called INCB000928 to help people with a rare condition called fibrodysplasia ossificans progressiva (FOP). FOP causes soft tissues to turn into bone, and there are few treatments available. The study will check if the drug is safe and effective in stopping or slowing this abnormal bone growth.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:2 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, HIV, HBV, HCV, Others
Must Not Be Taking:Antibiotics, Antifungals, Antivirals
98 Participants Needed
PET Radioligands for Rheumatoid Arthritis
Bethesda, MarylandBackground:
Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation. Two new drugs may create better PET images.
Objective:
To see if the drug \[11C\]MC1 can help image inflammation.
Eligibility:
People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).
Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.
Design:
Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.
Participants with arthritis or IIM will have a screening visit. This will include:
Medical history
Physical exam
Blood and urine tests
Possible CT or X-ray: A machine will take pictures of the body.
Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.
Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.
Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:HIV, Cardiovascular Disease, Pregnancy, Others
Must Not Be Taking:NSAIDs, Probenecid
30 Participants Needed
Ulviprubart for Inclusion Body Myositis
Henrico, VirginiaABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:
* Have completed the Part 2 (Multiple Ascending Dose \[MAD\]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR
* Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40+
Sex:All
270 Participants Needed
Garetosmab for Stone Man Syndrome
Nashville, TennesseeThis trial is testing garetosmab, an experimental drug, in adults with fibrodysplasia ossificans progressiva (FOP). The drug aims to stop or slow down abnormal bone growth by blocking a specific protein. The study will also look at side effects and how the body reacts to the drug.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
63 Participants Needed
Sirolimus for Inclusion Body Myositis
Baltimore, MarylandThis trial tests Sirolimus, a drug used in organ transplants, on patients with Inclusion Body Myositis (IBM). IBM causes muscle weakness, and current treatments are often ineffective. Sirolimus may help by calming harmful immune responses and cleaning up damaged proteins in muscle cells. Sirolimus has been used in organ transplant recipients to reduce the risk of skin cancer and manage immune system activity.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:45+
Sex:All
140 Participants Needed
KYV-101 for Autoimmune Diseases
Philadelphia, PennsylvaniaThe purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
24 Participants Needed
Andecaliximab for Stone Man Syndrome
Philadelphia, PennsylvaniaThis study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP.
The study is looking at several research questions, including:
* Safety of andecaliximab in participants with FOP
* Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; HO)
* Whether andecaliximab reduces the number or severity of flare-ups
* Pharmacokinetics/pharmacodynamics (PK/PD): How much study drug is in your blood at different times and its impact on blood biomarker(s)
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:2+
Sex:All
Key Eligibility Criteria
Disqualifiers:Fractures, Surgery, Infections, Malignancy, Others
Must Not Be Taking:Corticosteroids, NSAIDs, Tetracyclines, Palovarotene
92 Participants Needed
Oral Fidrisertib for Stone Man Syndrome
Philadelphia, PennsylvaniaThis trial tests IPN60130, a drug aimed at stopping or reducing unwanted bone growth, in adults and children with FOP. FOP causes bone to form in soft tissues, leading to severe disability. The medication works by blocking the process that leads to this abnormal bone growth.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5+
Sex:All
113 Participants Needed
Rapcabtagene Autoleucel for Myositis
Iowa City, IowaA Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Myopathies, Organ Dysfunction, Others
123 Participants Needed
NKX019 for Systemic Sclerosis
Hackensack, New JerseyThis is an open-label, multi-center, multi-cohort, non-randomized Phase 1 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with Immune-Mediated Diseases (IMD) including systemic sclerosis \[SSc\], idiopathic inflammatory myopathies \[IIM\], and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis \[AAV\].
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Renal Failure, Liver Disease, Major Cardiac, Others
72 Participants Needed
ADI-001 for Lupus Nephritis
Manhasset, New YorkADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Liver Disease, Gene Therapy, Others
180 Participants Needed
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Frequently Asked Questions
How much do Myositis 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 Myositis 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 Myositis 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 for Myositis 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 Myositis 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 Myositis clinical trials ?
Most recently, we added AZD5492 for Lupus and Myositis, CTX112 for Lupus and CNTY-101 for Lupus to the Power online platform.