Clinical trials: Immune-Mediated Inflammatory Disease
Immune Mediated Inflammatory Diseases
A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male Participants
The immune system helps protect the body from diseases. But, sometimes the immune system can be too sensitive and overreact to very small allergens, like dust and pet dander.
- Trial name
- NCT05003089
- Testing
- BAY1834845, BAY1830839, Prednisolone
- Where
- Netherlands
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Bayer
Immune-Mediated Inflammatory Disease
Digital Health Program With Participants Using an Autoinjector
This is a prospective, single-arm, feasibility study. Up to thirty (30) participants meeting study eligibility criteria will use the SK-M11/3A1 digital health program for 12 weeks.
- Trial name
- NCT06112184
- Testing
- SK-M11/3A1 Digital health program
- Where
- Iceland
- Volunteers
- 27 people
- Sponsor
- Sidekick Health
Idiopathic Inflammatory Myopathies
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
A 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)
- Trial name
- NCT06665256
- Testing
- Rapcabtagene autoleucel, Active Comparator Option
- Where
- 68 sites in United States, Australia and 13 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Inflammatory Myopathy, Dermatomyositis
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RESET-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
- Conditions
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- NCT06154252
- Testing
- CABA-201 following preconditioning with fludarabine and cyclophosphamide
- Where
- 38 sites in United States, Germany and 2 more
- Volunteers
- 74 people
- Sponsor
- Cabaletta Bio
COVID-19
Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases
The purpose of the study is to evaluate the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine (SCB-2019) in adult participants with stable…
- Trial name
- COVID-19 (NCT05012787)
- Testing
- CpG 1018/Alum-adjuvanted SCB-2019 vaccine, Havrix
- Where
- 4 sites in Ukraine
- Volunteers
- 1 people
- Sponsor
- Clover Biopharmaceuticals AUS Pty
Crohn Disease, Colitis, Ulcerative
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's…
- Trial name
- TENOR (NCT03606499)
- Testing
- Ustekinumab
- Where
- France
- Volunteers
- 111 people
- Sponsor
- Janssen Cilag S.A.S.
Asthma
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic…
- Trial name
- NCT06488703
- Where
- Germany
- Volunteers
- 107,032 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-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…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Active Idiopathic Inflammatory Myopathy, Myositis
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA (NCT05523167)
- Testing
- EFG PH20 SC, PBO
- Where
- 202 sites in United States, Argentina and 34 more
- Volunteers
- 265 people
- Sponsor
- argenx
Crohn's Disease, Rheumatoid Arthritis
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated…
- Conditions
- Crohn's Disease, Rheumatoid Arthritis, Psoriasis
- Trial name
- VITALITY (NCT02451839)
- Volunteers
- 168 people
- Sponsor
- AbbVie
Psoriatic Arthritis
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.
- Trial name
- NCT04711902
- Testing
- AIN457
- Where
- 12 sites in China
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Eosinophilic Esophagitis (EoE)
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding…
- Trial name
- EoE-TOTs (NCT07112378)
- Testing
- dupilumab
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
RA
PET-Based Imaging of Radiolabeled CIT-013
Inflammatory mediated immune diseases (IMIDs), such as rheumatoid arthritis (RA) and hidradenitis suppurativa (HS), are characterized by chronic inflammation resulting from an aberrant immune response.
- Trial name
- Cityview (NCT07147959)
- Testing
- [89Zr]Zr-CIT
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- Citryll BV
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Ankylosing Spondylitis (AS), Psoriasis
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
- Conditions
- Ankylosing Spondylitis (AS), Psoriasis, Rheumatoid Arthritis (RA)
- Trial name
- ADMIT (NCT03339089)
- Where
- 10 sites in China
- Volunteers
- 224 people
- Sponsor
- AbbVie
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Atopic Dermatitis, Alopecia Areata
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice.
- Conditions
- Atopic Dermatitis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo
- Trial name
- TARGET-DERM (NCT03661866)
- Where
- 62 sites in United States, Canada and 2 more
- Volunteers
- 15,000 people
- Sponsor
- Target PharmaSolutions, Inc.
B-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Trial name
- NCT06680037
- Testing
- Azercabtagene zapreleucel (azer-cel)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- TG Therapeutics, Inc.
Myositis, Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
- Conditions
- Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA+ (NCT05979441)
- Testing
- Efgartigimod PH20 SC
- Where
- 92 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- argenx