Clinical trials: Systemic Sclerosis in Adults
Healthy Volunteers, Systemic Sclerosis (SSc)
A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
- Conditions
- Healthy Volunteers, Systemic Sclerosis (SSc), Scleroderma, Systemic, Scleroderma
- Trial name
- NCT07641634
- Testing
- PRO-203
- Where
- 13 sites in Australia, China and 2 more
- Volunteers
- 44 people
- Sponsor
- Prolium Bioscience, Inc
Systemic Sclerosis (SSc), Scleroderma
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label…
- Trial name
- NCT06843239
- Testing
- Tibulizumab
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 80 people
- Sponsor
- Zura Bio Inc
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
- Trial name
- NCT02260557
- Testing
- Selexipag
- Where
- 16 sites in France, Germany and 1 more
- Volunteers
- 74 people
- Sponsor
- Actelion
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD).
- Trial name
- BLISSc-ILD (NCT05878717)
- Testing
- Belimumab
- Where
- 134 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.
- Trial name
- NCT04138485
- Testing
- IgPro10
- Where
- 77 sites in United States, Argentina and 11 more
- Sponsor
- CSL Behring
Diffuse Cutaneous Systemic Sclerosis
A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ…
- Trial name
- FREEDOM-3 (NCT05098145)
- Testing
- FCR001
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Scleroderma
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
- Trial name
- MEDI-546 (NCT00930683)
- Testing
- MEDI-546
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- MedImmune LLC
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Refractory Lupus Nephritis, Refractory Systemic Sclerosis
A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)
The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) tolerate TAK-007 and to check for side effects (adverse events).
- Trial name
- NCT06377228
- Testing
- TAK-007, Chemotherapy Agents
- Where
- United States
- Sponsor
- Takeda
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Study of AZD0120 in Autoimmune Diseases
This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc)…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- AURORA (NCT07295847)
- Testing
- AZD0120
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines…
- Trial name
- NCT05626751
- Testing
- HZN-825
- Where
- 65 sites in United States, Argentina and 13 more
- Volunteers
- 174 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Trial name
- ATTRACT (NCT07732309)
- Testing
- ATG-201
- Where
- 22 sites in China
- Volunteers
- 149 people
- Sponsor
- Antengene Biologics Limited
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This 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…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually…
- Trial name
- RE-WARM (NCT07748000)
- Testing
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm, LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Volunteers
- 75 people
- Sponsor
- Liquidia Technologies, Inc.
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
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
Systemic Sclerosis
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this…
- Trial name
- NCT07047690
- Testing
- Nemolizumab
- Where
- 3 sites in United States, Switzerland
- Volunteers
- 162 people
- Sponsor
- Galderma R&D
Scleroderma, Systemic
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis.
- Trial name
- VITALISScE™ (NCT05559580)
- Testing
- Avenciguat (BI 685509)
- Where
- 168 sites in United States, Argentina and 35 more
- Volunteers
- 214 people
- Sponsor
- Boehringer Ingelheim
Connective Tissue Diseases
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the…
- Trial name
- NCT06716606
- Testing
- Belimumab
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 514 people
- Sponsor
- GlaxoSmithKline