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NCT06716606PHASE3Recruiting

A 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) (BLISSconneCTD-OLE)

GlaxoSmithKline

Start Date

12/12/2024

Completion Date

10/23/2030

Summary

This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. 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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Belimumab

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Conditions

Connective Tissue Diseases

Locations

GSK Investigational Site

Los Angeles, California 90095

United States

GSK Investigational Site

New York, New York 11201

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19104

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19140

United States

GSK Investigational Site

Buenos Aires, C1425AGC

Argentina

GSK Investigational Site

Buenos Aires,

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1425

Argentina

GSK Investigational Site

Santa Fe, 3000

Argentina

GSK Investigational Site

Fitzroy, Victoria 3065

Australia

GSK Investigational Site

Beijing, 100020

China

GSK Investigational Site

Beijing, 100730

China

GSK Investigational Site

Chengdu, 610072

China

GSK Investigational Site

Hangzhou, 310052

China

GSK Investigational Site

Mianyang,

China

GSK Investigational Site

Shanghai, 200001

China

GSK Investigational Site

Shanghai, 200040

China

GSK Investigational Site

Shenyang, 110001

China

GSK Investigational Site

Zhuzhou, 412007

China

GSK Investigational Site

Toulouse, 31059

France

GSK Investigational Site

Larissa, 41110

Greece

GSK Investigational Site

Thessaloniki, 546 42

Greece

GSK Investigational Site

Poria – Neve Oved, Israel 15208

Israel

GSK Investigational Site

Aichi, 470-1192

Japan

GSK Investigational Site

Gunma, 371-8511

Japan

GSK Investigational Site

Hiroshima, 734-8551

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Tokushima, 770-8503

Japan

GSK Investigational Site

Tokyo, 113-8519

Japan

GSK Investigational Site

Tokyo, 113-8603

Japan

GSK Investigational Site

Tokyo, 143-8541

Japan

GSK Investigational Site

Yamanashi, 409-3898

Japan

GSK Investigational Site

Bucheon Kyunggi-Do, 420-717

South Korea

GSK Investigational Site

Seoul, 04763

South Korea

GSK Investigational Site

Suwon Kyunggi-do, 16499

South Korea

GSK Investigational Site

Yongsan-Ku Seoul,

South Korea

GSK Investigational Site

Bilbao, Bizkaia 48013

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

VigoPontevedra, 36200

Spain

GSK Investigational Site

Leeds, LS7 4SA

United Kingdom

GSK Investigational Site

London, NW3 2QG

United Kingdom