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Monoclonal Antibodies

Belimumab for Interstitial Lung Disease (BEconneCTD-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 rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria

Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of ≥ 10% of the whole lung (WLILD)

Must not have

Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC < 0.7

Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of assignment (day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 weeks

Awards & highlights

Summary

This trial will investigate whether adding a medication called belimumab to standard therapy can help stabilize or improve lung function and reduce symptoms in participants with connective tissue disease-associated interstitial lung disease (ILD).

Who is the study for?

This trial is for adults with a lung condition called Interstitial Lung Disease (ILD) that's linked to Connective Tissue Disease (CTD). Participants should have symptoms like reduced lung volume, breathlessness, coughing, and fatigue. The study seeks individuals who can take additional standard therapy alongside the trial treatment.

What is being tested?

The study is testing Belimumab versus a placebo to see if it helps stabilize or improve lung function and symptoms in patients with ILD associated with CTD. It aims to determine if adding Belimumab to regular treatments offers better outcomes.

What are the potential side effects?

Belimumab may cause side effects such as infections, allergic reactions, headaches, nausea, fever and possible infusion-related reactions. As this medication affects the immune system, there might be an increased risk of getting sick.

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 RA, SLE, IIM, pSS, or MCTD.

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My lung scans show I have interstitial lung disease affecting more than 10% of my lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition that makes it hard to breathe.

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My lung scans show more damage from emphysema than from ILD.

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I have never had bleeding in my lungs or similar lung problems.

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I have been diagnosed with a lung disease that is not caused by connective tissue disease.

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My primary diagnosis is Systemic Sclerosis.

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My lung function has rapidly declined recently.

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I have high blood pressure in the lungs needing treatment.

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I do not have major health issues that could affect drug processing or pose a risk with the study treatment.

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I have been diagnosed with PML or have new or worsening neurological symptoms.

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I was diagnosed with breast cancer in the last 10 years.

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I haven't had major surgery in the last 3 months and don't plan any during the study.

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I currently have an infection or have had infections in the past.

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My lung function is severely reduced or I need extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of assignment (day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of assignment (day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of assignment (day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52

Secondary study objectives

Absolute Change from Baseline in FVC Percentage (%) Predicted 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 Kings Brief. Interstitial Lung Disease Questionnaire (K-BILD) at Week 52

+10 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156

36%

Nasopharyngitis

18%

Hypokalaemia

Cystitis

Gastroenteritis

Periodontal disease

Joint injury

Vertigo

Ocular discomfort

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

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

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,788 Previous Clinical Trials

8,176,367 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,601 Previous Clinical Trials

6,144,574 Total Patients Enrolled

~293 spots leftby Oct 2028

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