Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Public ClinicalTrials.gov record NCT03398837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.
Study identification
- NCT ID
- NCT03398837
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 365 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2017
- Primary completion
- May 26, 2020
- Completion
- Dec 20, 2020
- Last update posted
- Mar 28, 2021
2017 – 2020
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037 | — |
| Pacific Arthritis Care Center | Los Angeles | California | 90045 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| John Hopkins University, Scleroderma Center | Baltimore | Maryland | 21224 | — |
| Massachusetts General Hospital, Division of Rheumatology | Boston | Massachusetts | 02114 | — |
| Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU) | Boston | Massachusetts | 02118 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota Health Clinical Research Unit | Minneapolis | Minnesota | 55455 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Rutgers Clinical Research Center, Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| The Steffens Scleroderma at The Center for Rheumatology | Albany | New York | 12203 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Hospital for Special Surgery | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| University of Pennsylvania Health System - PCAM, Dept. of Rheumatology | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Arthritis and Autoimmunity Center, Falk Clinic | Pittsburgh | Pennsylvania | 15261 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
| UTP Rheumatology Clinic | Houston | Texas | 77030 | — |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | — |
| Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03398837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03398837 live on ClinicalTrials.gov.