← Back to Search

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
Pivotal Trial

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
Select...
I have been diagnosed with RA, SLE, IIM, pSS, or MCTD.
Select...
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:
Select...
I have a lung condition that makes it hard to breathe.
Select...
My lung scans show more damage from emphysema than from ILD.
Select...
I have never had bleeding in my lungs or similar lung problems.
Select...
I have been diagnosed with a lung disease that is not caused by connective tissue disease.
Select...
My primary diagnosis is Systemic Sclerosis.
Select...
My lung function has rapidly declined recently.
Select...
I have high blood pressure in the lungs needing treatment.
Select...
I do not have major health issues that could affect drug processing or pose a risk with the study treatment.
Select...
I have been diagnosed with PML or have new or worsening neurological symptoms.
Select...
I was diagnosed with breast cancer in the last 10 years.
Select...
I haven't had major surgery in the last 3 months and don't plan any during the study.
Select...
I currently have an infection or have had infections in the past.
Select...
My lung function is severely reduced or I need extra oxygen.

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
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
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
4,808 Previous Clinical Trials
8,380,938 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,278 Total Patients Enrolled
~293 spots leftby Oct 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top