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Scleroderma, Diffuse clinical trials

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NCT ID: NCT05181644 Terminated - Scleroderma Clinical Trials

Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

SUITABLE
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

NCT ID: NCT04948554 Terminated - Clinical trials for Systemic Sclerosis With and Without Interstitial Lung Disease

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)

Start date: March 10, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.

NCT ID: NCT04915950 Terminated - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Start date: November 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral temanogrel improves digital blood flow in participants with Raynaud's phenomenon secondary to systemic sclerosis (SSc-RP) as a potential safe and effective treatment for symptoms associated with SSc-RP.

NCT ID: NCT04837131 Terminated - Systemic Sclerosis Clinical Trials

A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.

NCT ID: NCT04680975 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis

dcSSC
Start date: March 3, 2021
Phase: Phase 2
Study type: Interventional

This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc). An estimated total of 12 to 15 participants would receive belumosudil 200 milligrams (mg) administered orally (PO) twice daily (BID) for 52 weeks. The primary analysis was at 24 weeks.

NCT ID: NCT04478994 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Start date: November 17, 2021
Phase: Phase 1
Study type: Interventional

The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every 3 weeks (q3W) for 24 weeks in the treatment of participants with diffuse cutaneous systemic sclerosis (dcSSc).

NCT ID: NCT04178616 Terminated - Scleroderma Clinical Trials

Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

SCLEROLF
Start date: December 31, 2019
Phase: N/A
Study type: Interventional

Prospective monocentric study of patients with systemic sclerosis disease. The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease. The secondary outcomes are: - To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients. - To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease

NCT ID: NCT03976648 Terminated - Systemic Sclerosis Clinical Trials

A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.

NCT ID: NCT03919799 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

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. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams [mg] once daily [QD] and 200 mg twice daily [BID]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.

NCT ID: NCT03740724 Terminated - Scleroderma Clinical Trials

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)

Start date: December 18, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 is designed to be injected under the skin at the location of the fibrotic lesions where the genetically-modified fibroblast cells will produce MMP-1 to break down excess collagen accumulation. With the FCX-013 therapy, the patient will take an oral compound (Veledimex) to induce MMP-1 protein expression from the injected cells. Once the fibrosis is resolved, the patient will stop taking the oral compound which will stop further MMP-1 production from the injected cells. FCX-013 plus veledimex is being developed in anticipation of improving skin function in patients by resolving fibrotic lesions and normalizing dermal collagen production