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Monoclonal Antibodies

Belimumab for Systemic Sclerosis Interstitial Lung Disease (BLISSc-ILD Trial)

Phase 3

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria

Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 26 and week 52

Awards & highlights

BLISSc-ILD Trial Summary

This trial studies the safety and effectiveness of a drug to treat lung and other symptoms of systemic sclerosis, a chronic autoimmune disorder.

Who is the study for?

Adults with systemic sclerosis associated interstitial lung disease (SSc-ILD) who are not pregnant or breastfeeding, can self-administer medication or have a caregiver to do so, and meet specific criteria for skin thickening and lung involvement. Excluded are those with significant emphysema, recent major organ transplants, similar conditions caused by drugs/environmental factors, certain treatments like rituximab within the last 6 months, severe heart/lung/kidney diseases, other autoimmune disorders besides SSc-ILD.Check my eligibility

What is being tested?

The trial is testing the effectiveness of belimumab versus placebo in improving lung function and reducing symptoms related to systemic sclerosis such as skin thickening and fatigue. Participants will receive either belimumab or a placebo alongside their standard therapy to see if there's an improvement in their condition.See study design

What are the potential side effects?

Belimumab may cause side effects including infections due to weakened immune response; allergic reactions; infusion-related reactions like headache or nausea; possible depression; gastrointestinal issues; fever; insomnia. The severity of these side effects varies from person to person.

BLISSc-ILD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria.

Select...

I have thickened skin above my elbows or knees and in areas further away.

Select...

I can take my medication by myself or have someone who can help me.

Select...

My disease is getting worse.

BLISSc-ILD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 26 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 26 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52

Secondary outcome measures

Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52

Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52

Absolute change from baseline in DLco % predicted at Week 52

+19 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156

36%

Nasopharyngitis

18%

Hypokalaemia

Gastroenteritis

Cystitis

Joint injury

Vertigo

Ocular discomfort

Periodontal disease

Lumbar vertebral fracture

Upper respiratory tract infection

Dental caries

Musculoskeletal chest pain

Cough

Otitis externa bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Phase: Treatment Holiday Group - Re-start Phase

Maintenance Phase: Treatment Holiday

Treatment Phase: Long-term Discontinuation Group

Treatment Phase: Treatment Control Group

Treatment Phase: Treatment Holiday Group - Holiday Phase

Maintenance Phase: Treatment Control

BLISSc-ILD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BelimumabExperimental Treatment1 Intervention

Participants will receive belimumab in addition to standard therapy.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo in addition to standard therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belimumab

2013

Completed Phase 4

~1840

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,535 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there detrimental effects associated with Belimumab usage?

"Belimumab has been studied extensively, which justifies its score of 3 on our safety scale. Data suggests that this medication is effective and safe for use in a Phase 3 trial."

Answered by AI

Is there a broad geographical spread of sites in the US administering this trial?

"Presently, the trial is operational at 107 sites across Scottsdale, Tucson and Los Angeles. To reduce travel difficulties for participants, it would be best to select a site closest to one's current location."

Answered by AI

Are there any open slots in this experiment for volunteers?

"According to clinicaltrials.gov, the trial that was initially posted on September 29th 2023 is no longer accepting candidates at this time. However, there are 818 other active studies searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878717.

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