Clinical trials: SSc-Systemic Sclerosis
Systemic Sclerosis
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
- Trial name
- LOTUSS (NCT01933334)
- Testing
- Pirfenidone
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 63 people
- Sponsor
- Genentech, Inc.
Systemic Sclerosis (SSc)
DERMATOMICS: Identifying Regulators of Skin Homeostasis
Diseases of the skin associated with chronic immune driven conditions, including scleroderma, lupus, dermatomyositis, psoriasis, and atopic dermatitis, significantly impact skin integrity, function, and overall quality of life.
- Trial name
- DERMATOMICS (NCT06894654)
- Testing
- Skin punch biopsy, blood sampling, Questionnaire
- Where
- 2 sites in United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Relation Therapeutics
Scleroderma, Systemic, Digital Ulcer
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers).
- Trial name
- NCT06256575
- Testing
- Diosmin
- Where
- 5 sites in Canada
- Volunteers
- 45 people
- Sponsor
- Primus Pharmaceuticals
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
Autoimmune Diseases
EBMT ADWP Prospective Non-interventional Study: Post-AHSCT Management in SSC Patients (NISSC-2)
The aim of the study is to assess the effectiveness of various post-transplant treatment management approaches on clinical and immune biological responses after Autologous Hematopoietic Stem Cell transplantation (AHSCT) for…
- Trial name
- NISSC-2 (NCT03444805)
- Testing
- Autologous HSCT
- Where
- France
- Volunteers
- 60 people
- Sponsor
- European Society for Blood and Marrow Transplantation
Autoimmune Diseases
EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients
The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study…
- Trial name
- NISSC (NCT02516124)
- Testing
- Autologous HSCT
- Where
- France
- Volunteers
- 82 people
- Sponsor
- European Society for Blood and Marrow Transplantation
Lung Diseases, Interstitial
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
- Trial name
- NCT03313180
- Testing
- Nintedanib
- Where
- 159 sites in United States, Argentina and 28 more
- Volunteers
- 444 people
- Sponsor
- Boehringer Ingelheim
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
Systemic Sclerosis (SSc)
A Study of GB261 in Systemic Sclerosis
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of GB261 in patients with SSc.
- Trial name
- NCT07159009
- Testing
- Biological: GB261
- Volunteers
- 10 people
- Sponsor
- Ruijin Hospital
Interstitial Lung Disease Due to Systemic Disease, Scleroderma
Platform Clinical Study for Conquering Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with…
- Trial name
- CONQUEST (NCT06195072)
- Testing
- Amlitelimab, BI 1015550 (Nerandomilast)
- Where
- 34 sites in United States
- Volunteers
- 400 people
- Sponsor
- Scleroderma Research Foundation, Inc.
Systemic Sclerosis
A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis
The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).
- Trial name
- NCT04744207
- Testing
- GS-248
- Where
- 12 sites in Belgium, Netherlands and 2 more
- Volunteers
- 94 people
- Sponsor
- Gesynta Pharma AB
Interstitial Lung Disease Due to Systemic Disease (Disorder)
Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF
Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc.
- Trial name
- upadacetinib (NCT06758947)
- Testing
- Upadacitinib 15 MG, Cellcept Oral Product
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Scleroderma, Ssc
Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures.
- Trial name
- NCT02837549
- Testing
- Occupational therapy treatment
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan
Systemic Sclerosis (SSc), Scleroderma
Patients Diagnosed With Scleroderma: Physical Performance and Functionality
Physical functionality and performance are important for individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial…
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized
- Trial name
- NCT07183072
- Testing
- Questionnaire and functionality application for child and adult scleroderma patients
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Systemic Sclerosis, Scleroderma
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Scleroderma, Interstitial Lung Diseases
- Trial name
- NCT06328777
- Testing
- CABA-201
- Where
- 10 sites in United States
- Volunteers
- 37 people
- Sponsor
- Cabaletta Bio
Systemic Sclerosis (SSc), Sexual Dysfunctions
Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis
Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis
- Conditions
- Systemic Sclerosis (SSc), Sexual Dysfunctions, Pelvic Floor Disorder
- Trial name
- NCT06769399
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Systemic Sclerosis
RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)
As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force…
- Trial name
- REUSSI-SSc (NCT04001556)
- Testing
- Minor Salivary gland Biopsy, ARFI, MSG US
- Where
- 3 sites in France
- Volunteers
- 75 people
- Sponsor
- Rennes University Hospital
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
GC012F in Patients With Autoimmune Diseases
This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic…
- Trial name
- NCT07072884
- Testing
- GC012F injection
- Volunteers
- 15 people
- Sponsor
- Qiong Fu
SSc-Systemic Sclerosis
Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment
- Trial name
- NCT07491523
- Testing
- Antifibrotic drugs (nidanib or pirfenidone), MMF Immunosuppression
- Where
- Greece
- Volunteers
- 35 people
- Sponsor
- University of Patras
Systemic Sclerosis-Associated PAH
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis)…
- Trial name
- NCT01086540
- Testing
- Rituximab, CMRI, prednisone
- Where
- 17 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)