Today, we are looking into the latest clinical trials focused on scleroderma (systemic sclerosis). This series aims to offer a glimpse into upcoming innovations and research, and how the outcomes of these studies could potentially influence clinical guidelines related to scleroderma.
The following list features ongoing Phase 3 trials involving scleroderma. Please note that the dates provided are approximate and subject to change.
Quick View Table of Scleroderma Clinical Trials
| Study Title | Phase | Enrollment | Start Date | Last Update Posted |
|---|---|---|---|---|
| Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 3 | 306 | November 8, 2023 | April 8, 2025 |
| A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (BLISSc-ILD) | 3 | 300 | September 13, 2023 | April 28, 2025 |
Phase 3 Clinical Trials
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
- Sponsor: AstraZeneca
- Goal: The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis.
- Interventions: Anifrolumab/Placebo
- Primary Outcome Measures: Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
- Timeframe: 52 weeks
- Study Details
- Source
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (BLISSc-ILD)
- Sponsor: GlaxoSmithKline
- Goal: 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).
- Interventions: Belimumab/Placebo
- Primary Outcome Measures: Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52.
- Timeframe: 52 weeks
- Study Details
- Source
Potential Guidelines That May Be Affected Include:
Management of Systemic Sclerosis
- British Society for Rheumatology
- Latest Update: November 2024
- European Academy of Dermatology and Venereology
- Latest Update: March 2024
Treatment of Systemic Sclerosis
- European League Against Rheumatism
- Latest Update: October 2024
Treatment of Systemic Sclerosis–associated Interstitial Lung Disease: Evidence-based Recommendations
- American Thoracic Society
- Latest Update: May 2023
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