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1 for Systemic Scleroderma

Phase 1
Waitlist Available
Led By Stephen J. Oliver, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal connective tissue growth of the skin and internal organs. At this point, there are no effective therapies for treating SSc. Thalidomide is a medication that has been shown to stimulate an immune response that reduces the body's synthesis of collagen, the main component of connective tissue. This study will determine the effectiveness of thalidomide in treating adults with SSc.

Eligible Conditions
  • Systemic Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 4 trial • 93 Patients • NCT03122431
60%
Only sensory peripheral neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
SLE/Cutaneous Lupus With Thalidomide
Inactive SLE With Standard Dose of HCQ
Inactive SLE With Reduced Dose of HCQ

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Participants will receive thalidomide.
Group II: 2Placebo Group1 Intervention
Participants will receive placebo thalidomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thalidomide
FDA approved

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,812 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,400 Total Patients Enrolled
Stephen J. Oliver, MDPrincipal InvestigatorNYU Langone Health
~1 spots leftby Sep 2025
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