Investigating the long-term effects of Belimumab in adults with lung disease related to systemic sclerosis

An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD)

This study is testing if the medication Belimumab can help adults with lung disease related to systemic sclerosis feel better and slow down their disease over the long term.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: radiation, belimumab
• Locations: 10 sites (Philadelphia, Pennsylvania and 9 other locations)
• Trial ID: NCT06716606 on ClinicalTrials.gov

What this trial studies

This open-label extension study evaluates the long-term safety and efficacy of Belimumab in adults who have systemic sclerosis associated interstitial lung disease (SSc-ILD). Participants must have completed a prior study and will receive Belimumab to assess its tolerability, impact on lung function decline, and overall disease progression. The study aims to improve the quality of life for patients suffering from this condition through ongoing treatment. It involves self-administration of the medication or administration by a caregiver.

Who should consider this trial

Good fit: Ideal candidates are adults with systemic sclerosis associated interstitial lung disease who have completed a prior study without treatment failure.

Not a fit: Patients who have initiated new immunosuppressive treatments or discontinued study medication during the prior study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option that may slow disease progression and improve quality of life for patients with SSc-ILD.

How similar studies have performed: Other studies have shown promising results with Belimumab in related conditions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria:

  * Discontinuation of study medication during study 218224 or 221672 for any reason.
* Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh.
* Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to administer the study medication throughout the study.
* Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.

1. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.
2. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
3. Additional requirements for pregnancy testing during and after study intervention are located.
4. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

   * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria:

* Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52.
* Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk.
* Participants who have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the investigator could significantly alter the absorption, metabolism, or elimination of drugs; constitutes a risk when taking the study intervention; interferes with the interpretation of data; or it is not safe for the participant to continue on the study.
* Participants who have been exposed to ionizing radiation in excess of 10 millisievert (mSv) above background over the previous 3 year period as a result of occupational exposure or previous participation in research studies.
* QT Interval Corrected (QTc) greater than (\>) 480 millisecond (msec) at Week 52 of parent study 218224 or study 221672.

Where this trial is running

Philadelphia, Pennsylvania and 9 other locations

• GSK Investigational Site — Philadelphia, Pennsylvania, United States (Recruiting)
• GSK Investigational Site — Ciudad Autonoma Buenos Aires, Argentina (Recruiting)
• GSK Investigational Site — Ciudad Autonoma de Buenos Aire, Argentina (Recruiting)
• GSK Investigational Site — Beijing, China (Recruiting)
• GSK Investigational Site — Zhuzhou, China (Recruiting)
• GSK Investigational Site — Larissa, Greece (Recruiting)
• GSK Investigational Site — Hokkaido, Japan (Recruiting)
• GSK Investigational Site — Tokyo, Japan (Recruiting)
• GSK Investigational Site — Yongsan-Ku Seoul, South Korea (Recruiting)
• GSK Investigational Site — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Connective Tissue Diseases; Belimumab; Long-term; Open label extension; Interstitial lung disease; Diffuse cutaneous systemic sclerosis; Connective tissue disease