Clinical trial NCT06716606: A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Official title: An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bronchial Diseases
Keywords: Belimumab
long-term
open label extension
systemic sclerosis associated interstitial lung disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2024-12-04
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.


Eligibility criteria: Inclusion Criteria:

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

  1. Initiation of new immunosuppressive or immunomodulatory medication for SSc-related disease activity/progression since joining study 218224.
  2. Discontinuation of study medication during study 218224 for any reason.
* Participant has 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), 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 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 (i.e, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in Study 218224 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 (Day 1 of 219855).

Primary outcomes:
measure: Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Change from Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline (Day 1 of OLE study) and at Weeks 12, 26, 52,104, 156, 208 and 260
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: ZhuZhou
country: China
facility: GSK Investigational Site
city: Yongsan-Ku Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: