Clinical trials: Scleroderma, Diffuse
Scleroderma, Systemic
A Study of Guselkumab in Participants With Systemic Sclerosis
The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
- Trial name
- NCT04683029
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2
- Where
- 4 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Janssen Pharmaceutical K.K.
Systemic Sclerosis
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival.
- Trial name
- NCT06058091
- Testing
- RY_SW01 cell injection, Basic treatment
- Where
- China
- Volunteers
- 81 people
- Sponsor
- Jiangsu Renocell Biotech Company
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
Systemic Sclerosis (SSc), Systemic Sclerosis
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy
This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in…
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis, Systemic Sclerosis (Scleroderma), Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT07854483
- Testing
- C-CAR168
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- AbelZeta Inc.
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
- Trial name
- NCT03919799
- Testing
- Belumosudil (KD025)
- Where
- 26 sites in United States
- Volunteers
- 36 people
- Sponsor
- Kadmon, a Sanofi Company
Systemic Sclerosis
An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
The primary objective is to study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757.
- Trial name
- NCT01487551
- Testing
- paquinimod
- Where
- 6 sites in Germany, Sweden and 1 more
- Volunteers
- 9 people
- Sponsor
- Active Biotech AB
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT06400303
- Testing
- KYV-101, Standard lymphodepletion regimen
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kyverna Therapeutics
Sclerosis, Systemic
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis.
- Trial name
- NCT01532869
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Diffuse Cutaneous Systemic Sclerosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc).
- Trial name
- RESOLVE-1 (NCT03398837)
- Testing
- Lenabasum 5 mg, Lenabasum 20 mg
- Where
- 74 sites in United States, Australia and 10 more
- Volunteers
- 365 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis
This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- dcSSC (NCT04680975)
- Testing
- Belumosudil
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon, a Sanofi Company
Systemic Sclerosis, Scleroderma
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases.
- Trial name
- NCT00043706
- Testing
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- Where
- 4 sites in United States
- Sponsor
- Genzyme, a Sanofi Company
Scleroderma, Systemic Sclerosis
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand…
- Conditions
- Scleroderma, Systemic Sclerosis, Raynaud Phenomena, Raynaud's Disease
- Trial name
- STAR (NCT02396238)
- Testing
- Celution Device
- Where
- 19 sites in United States
- Volunteers
- 88 people
- Sponsor
- Cytori Therapeutics
Diffuse Cutaneous Systemic Sclerosis
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
- Trial name
- NCT04440592
- Testing
- MT-7117
- Where
- 34 sites in United States, Belgium and 6 more
- Volunteers
- 76 people
- Sponsor
- Tanabe Pharma America, Inc.
Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA)
Controlling Hyperactive Immunity With Long-lived Lymphocytes
This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid…
- Conditions
- Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Autoimmune Rheumatologic Disease
- Trial name
- CHILL (NCT07473154)
- Testing
- QEL-005
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 16 people
- Sponsor
- Quell Therapeutics Limited
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with…
- Trial name
- NCT04040322
- Testing
- Iloprost Injection, for intravenous use
- Where
- 30 sites in United States
- Volunteers
- 198 people
- Sponsor
- Civi Biopharma, Inc.
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06379646
- Testing
- YTS109
- Where
- China
- Volunteers
- 6 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.