It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life. One of the main forms of scleroderma is systemic sclerosis, which is the focus of today's clinical trials preview. The following five United States-based trials are arranged by start date and are all anticipated to complete within the next few years.

Active Clinical Trials on Systemic Sclerosis
Study TitlePhaseEstimated EnrollmentStart DateEstimated Primary Completion
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel /​ Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)392May 2026November 2028
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)285April 2026December 2028
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis2162February 2026May 2028
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)280February 2025May 2027
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (DAISY)3314November 2023January 2027

A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel /​ Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

  • Sponsor: Juno Therapeutics
  • Goal: The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis.
  • Interventions: BMS-986353, fludarabine, cyclophosphamide, tocilizumab, rituximab, nintedanib
  • Primary Outcome Measure: The absolute change from baseline in Forced Vital Capacity (FVC) in mL.
  • Time Line: At 12 months.
  • Study Details
  • Source

EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

  • Sponsor: Mediar Therapeutics
  • Goal: A Phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of MTX-474 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
  • Interventions: MTX-474, placebo
  • Primary Outcome Measure: Change from baseline in modified rodnan skin score (mRSS).
  • Time Line: Baseline to week 24.
  • Study Details
  • Source

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis

  • Sponsor: Galderma R&D
  • Goal: 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 target population.
  • Interventions: Nemolizumab, placebo
  • Primary Outcome Measure: Change From baseline in modified rodnan skin score at week 52.
  • Time Frame: Baseline at week 52.
  • Study Details
  • Source

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

  • Sponsor: Zura Bio Inc
  • Goal: 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 extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks.
  • Interventions: Tibulizumab, placebo
  • Primary Outcome Measures: Change from baseline in modified rodnan skin score (mRSS) at 24 weeks; Safety and tolerability of tibulizumab.
  • Time Frames: Week 24; Week 52.
  • Study Details
  • Source

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (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 (blinded), placebo (blinded), anifrolumab (unbinded, open label)
  • Primary Outcome Measure: Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25).
  • Time Frame: At week 52.
  • Study Details
  • Source
Related Clinical Guidelines:

Check out our other rheumatology-related content and be sure to sign up for alerts and stay informed on the latest published guidelines.