Clinical trials: Systemic Autoimmune Diseases
Systemic Lupus Erythematosus
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard…
- Trial name
- NCT01438489
- Testing
- Anifrolumab 300 mg, Anifrolumab 1000 mg
- Where
- 79 sites in United States, Brazil and 12 more
- Volunteers
- 626 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 17 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
Lupus Nephritis
Aurinia Renal Response in Active Lupus With Voclosporin
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
- Trial name
- AURORA (NCT03021499)
- Testing
- Voclosporin
- Where
- 185 sites in United States, Argentina and 29 more
- Volunteers
- 358 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)
FASENRA Regulatory Postmarketing Surveillance in Korea
As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by…
- Trial name
- FASENRA rPMS (NCT05091333)
- Where
- 5 sites in South Korea
- Volunteers
- 51 people
- Sponsor
- AstraZeneca
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
NUCALA® Special Drug Use Investigation (EGPA, Long-term)
This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in…
- Trial name
- NCT03557060
- Testing
- Nucala
- Where
- Japan
- Volunteers
- 4,115 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)
This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and…
- Trial name
- NCT06340490
- Testing
- RJMty19 (CD19-CAR-DNT cells)
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Guangdong Ruishun Biotech Co., Ltd
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
- Trial name
- NCT05306574
- Testing
- Telitacicept
- Where
- 78 sites in United States, Argentina and 13 more
- Volunteers
- 91 people
- Sponsor
- Vor Biopharma
Lupus Erythematosus, Systemic
JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus
The trial will evaluate pharmacodynamics，pharmacokinetics，safety，and efficacy of JMKX000189 versus placebo in participants with moderately to severely active systemic lupus erythematosus (SLE) while receiving standard of care…
- Trial name
- NCT05967520
- Testing
- JMKX000189
- Where
- 17 sites in China
- Volunteers
- 48 people
- Sponsor
- Jemincare
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE
- Trial name
- NCT02291588
- Testing
- AMG 811
- Volunteers
- 26 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE)
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and…
- Trial name
- SLEek (NCT03978520)
- Testing
- Elsubrutinib, Upadacitinib
- Where
- 160 sites in United States, Argentina and 19 more
- Volunteers
- 341 people
- Sponsor
- AbbVie
Spondyloarthritis
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions.
- Trial name
- Annexin 03 (NCT03232580)
- Testing
- rhAnnexin V-128
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Advanced Accelerator Applications
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus…
- Trial name
- REGENCY (NCT04221477)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 74 sites in United States, Argentina and 13 more
- Volunteers
- 271 people
- Sponsor
- Hoffmann-La Roche
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: The study duration will be a minimum of 180…
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- TITAN (NCT06916806)
- Testing
- AZD5492
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 72 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE…
- Trial name
- NCT00724867
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 51 sites in United States
- Volunteers
- 268 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus
Single Ascending Dose Study of AMG 570 in Healthy Subjects
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single…
- Trial name
- NCT02618967
- Testing
- AMG 570
- Where
- 3 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)
TQB3702 is a selective kinase inhibitor. This is a Phase II clinical study aimed at evaluating the efficacy and safety of TQB3702 tablets in patients with systemic lupus erythematosus.
- Trial name
- NCT06859931
- Testing
- TQB3702 Tablets
- Where
- 37 sites in China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN)
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with…
- Conditions
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL)
- Trial name
- NCT07491900
- Testing
- HB2198
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Hinge Bio