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Monoclonal Antibodies

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

Phase 2 & 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
Must not have
Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1
Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 52

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria.
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I have thickened skin above my elbows or knees and in areas further away.
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I can take my medication by myself or have someone who can help me.
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My disease is getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any strong chemotherapy drugs like chlorambucil in the last 6 months.
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I have been diagnosed with an autoimmune disease, but not dcSSc.
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My lung scans show more damage from emphysema than from ILD.
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I haven't taken any biologic drugs, like IVIG or monoclonal antibodies, in the last 3 months or 5 half-lives.
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I have had or am planning to have a major organ or bone marrow transplant.
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My lung function is severely reduced or I need extra oxygen.
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I have not taken cyclophosphamide in the last 6 months.
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I have been diagnosed with high blood pressure in the lungs.
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I have a lung condition that makes it hard to breathe.
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I haven't taken any corticosteroids by injection or IV in the last month.
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I haven't taken strong immune system suppressing drugs, except for mycophenolate, methotrexate, or azathioprine, in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
+8 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156
36%
Nasopharyngitis
18%
Hypokalaemia
9%
Cystitis
9%
Gastroenteritis
9%
Periodontal disease
9%
Joint injury
9%
Vertigo
9%
Ocular discomfort
9%
Lumbar vertebral fracture
9%
Upper respiratory tract infection
9%
Dental caries
9%
Musculoskeletal chest pain
9%
Cough
9%
Otitis externa bacterial
100%
80%
60%
40%
20%
0%
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

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
~1940

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,381,094 Total Patients Enrolled
~200 spots leftby Jul 2027
Unbiased ResultsWe believe in providing patients with all the options.
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