Belimumab for Interstitial Lung Disease

Recruiting at 76 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Disqualifiers: Unstable diseases, Excess radiation, QTc > 480, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

514 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests belimumab, a monoclonal antibody therapy, to determine its effectiveness for individuals with interstitial lung disease (ILD) linked to autoimmune conditions such as systemic sclerosis and other connective tissue diseases. The goal is to assess whether belimumab can slow lung damage and enhance long-term quality of life. Individuals who completed a previous related study without discontinuing their medication early may qualify. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that belimumab is likely to be safe for humans?

Research has shown that belimumab is generally safe for patients. In studies on its use for lung disease related to connective tissue disorders, belimumab demonstrated a good safety record. Some participants experienced side effects, usually mild to moderate. Common side effects include headaches and minor infections, typical for many medications. Notably, the FDA has already approved belimumab for other conditions, supporting its safety. Overall, while side effects can occur, evidence suggests belimumab is safe for many patients when healthcare professionals monitor its use. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for interstitial lung disease?

Belimumab is unique because it targets B-lymphocyte stimulator (BLyS), a protein that plays a crucial role in the survival and development of B cells, which are involved in inflammatory processes. Unlike the standard treatments for interstitial lung disease, which often include corticosteroids and immunosuppressants that broadly suppress the immune system, Belimumab offers a more targeted approach by specifically inhibiting an overactive B-cell pathway. Researchers are excited about this treatment because it has the potential to reduce lung inflammation and damage with potentially fewer side effects, offering a promising alternative for patients who may not respond well to traditional therapies.

What evidence suggests that belimumab might be an effective treatment for interstitial lung disease?

Research has shown that belimumab, a type of medication, might help people with lung disease related to connective tissue diseases. Studies have found that belimumab can help maintain stable lung function, potentially slowing the progression of lung problems. This is crucial for individuals with conditions like diffuse cutaneous systemic sclerosis, where lung issues can become serious. Some trials have also demonstrated that belimumab is safe and well-tolerated by patients. Overall, early evidence suggests that belimumab could be a promising treatment for lung disease linked to connective tissue diseases. Participants in this trial will receive belimumab to further evaluate its effectiveness and safety for interstitial lung disease. ^{1 2 3 4 5}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults with interstitial lung disease linked to systemic sclerosis or other connective tissue diseases who were part of earlier studies (218224/NCT05878717 and 221672/NCT06572384) can join. They must be able to self-administer the drug or have someone who can do it for them, agree to pregnancy testing if applicable, and use effective contraception.

Inclusion Criteria

If my urine pregnancy test is unclear, I must take a blood test and cannot participate if positive.

I am aware of the need for pregnancy tests during and after the study.

I have a suitable skin area for injections in my abdomen or thigh.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive belimumab to assess long-term safety and efficacy in reducing lung function decline and improving quality of life

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belimumab

Trial Overview

The trial is studying Belimumab's long-term safety and effectiveness in slowing down lung function decline, overall disease progression, and improving quality of life in patients with ILD associated with systemic sclerosis or other CTDs.

How Is the Trial Designed?

Group I: Participants receiving Belimumab Experimental Treatment 1 Intervention

Participants will receive belimumab.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8639321/

Belimumab in the Treatment of Connective Tissue Disease ...

Rituximab, a biologic DMARD have been evaluated in the treatment of CTD-ILD and is shown to stabilize lung function and imaging in multiple ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06572384

NCT06572384 | A Study of the Efficacy and Safety ...

A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (BEconneCTD-ILD).

3.

actionpf.org

actionpf.org/research-study/a-study-investigating-the-impact-of-a-new-drug-belimumab-on-lung-function-for-people-with-interstitial-lung-disease-associated-with-connective-tissue-disease

A study investigating the impact of a drug, belimumab, on ...

A study investigating the impact of a drug, belimumab, on lung function for people with interstitial lung disease associated with connective tissue disease.

4.

ucla.clinicaltrials.researcherprofiles.org

ucla.clinicaltrials.researcherprofiles.org/interstitial-lung-disease

UCLA Interstitial Lung Disease Clinical Trials — Los Angeles

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003496724657687

AB0904 BELIMUMAB FOR THE TREATMENT OF ...

We present the design of a global Phase 2/3 study that will test the efficacy and safety of SC belimumab in patients with SSc-ILD.