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NCT05878717 · ClinicalTrials.gov registry record · Phase 2

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

A Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease, sponsored by GlaxoSmithKline.

Recruiting
Registry status
Phase 2
Development phase
300
Enrollment target
20
Study locations

NCT05878717 is a Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 300 participants, above the 34-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (782% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT05878717, a Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease, is actively recruiting participants, sponsored by GlaxoSmithKline.

RECRUITING
Registry status
Phase 2
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

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). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Conditions Studied

Scleroderma, Systemic Systemic Sclerosis Associated Interstitial Lung Disease

Interventions

  • OTHER Placebo
  • BIOLOGICAL Belimumab

Study Locations (20)

Arizona

  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Scottsdale
  • GSK Investigational Site - Scottsdale
  • GSK Investigational Site - Tucson

California

  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Upland

New York

  • GSK Investigational Site - New York
  • GSK Investigational Site - New York
  • GSK Investigational Site - Potsdam

Florida

  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Miami

Colorado

  • GSK Investigational Site - Aurora

District of Columbia

  • GSK Investigational Site - Washington D.C.

Illinois

  • GSK Investigational Site - Chicago

Maryland

  • GSK Investigational Site - Baltimore

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-09-13
Est. Completion 2029-07-12
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05878717

The ClinicalTrials.gov registry entry for NCT05878717 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 34-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (782% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Scleroderma, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05878717 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Arizona, California, New York.

Frequently Asked Questions

What is clinical trial NCT05878717 about?

NCT05878717 is a clinical study titled "A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease". 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). The study will evaluate the effect of belimumab treatment on lung function as w...

What is the current status of trial NCT05878717?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-09-13. Estimated completion is 2029-07-12.

What conditions does trial NCT05878717 study?

This clinical trial studies the following conditions: Scleroderma, Systemic, Systemic Sclerosis Associated Interstitial Lung Disease.

What interventions are being tested in trial NCT05878717?

The interventions under investigation include: Placebo (OTHER), Belimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05878717?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05878717 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.