Clinical trials: MYOSITIS
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
Dermatomyositis
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis.
- Trial name
- DETERMINE (NCT03813160)
- Testing
- Lenabasum 20 mg, Lenabasum 5 mg
- Where
- 54 sites in United States, Bulgaria and 11 more
- Volunteers
- 176 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of…
- Trial name
- NCT04829773
- Testing
- Palovarotene, midazolam
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
Polymyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids…
- Trial name
- NCT01801917
- Testing
- BAF312
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06371417
- Testing
- RAY121
- Where
- 77 sites in United States, Australia and 18 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
Dermatomyositis
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
- Trial name
- NCT05192200
- Testing
- Anti-Beta Interferon (PF-06823859)
- Where
- 25 sites in United States, Hungary and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Polymyositis, Dermatomyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or…
- Trial name
- NCT01148810
- Testing
- BAF312
- Where
- 6 sites in United States, Czechia and 3 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress.
- Trial name
- NCT01150526
- Testing
- CaHMB, HMB Free Acid Gel
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Metabolic Technologies Inc.
Idiopathic Inflammatory Myopathies
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis.
- Trial name
- VERANDA™-IIM (NCT07789015)
- Testing
- Nerandomilast
- Where
- 158 sites in United States, Argentina and 24 more
- Volunteers
- 270 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06970951
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Idiopathic Inflammatory Myopathies, Inflammatory Myopathies
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.
- Trial name
- NCT06524687
- Testing
- Imvotamab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- IGM Biosciences, Inc.
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
- Trial name
- NCT02780674
- Testing
- MEDI7734
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Antisynthetase Syndrome
Descartes-08 in Autoantibody Myositis
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen…
- Trial name
- NCT07391605
- Testing
- Descartes-08
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cartesian Therapeutics
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM)
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Trial name
- NCT07331272
- Testing
- LUCAR-G79D T cells
- Where
- 5 sites in China
- Volunteers
- 38 people
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Fibrodysplasia Ossificans Progressiva (FOP)
A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Primary Objective(s): To describe the demographic characteristics of people living with FOP and a matched cohort of non-FOP people living in the United States (U.S.) To describe the prevalence of clinical characteristics of…
- Trial name
- NCT06064656
- Testing
- Non-Interventional
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- Regeneron Pharmaceuticals
Inclusion Body Myositis
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.
- Trial name
- NCT02753530
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 152 people
- Sponsor
- ZevraDenmark
Dermatomyositis, Polymyositis
Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")
- Conditions
- Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies
- Trial name
- FROG (NCT05833711)
- Testing
- Froniglutide
- Where
- South Korea
- Volunteers
- 39 people
- Sponsor
- Immunoforge Co. Ltd.