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Can a lupus drug protect lungs in connective tissue disease?

NCT ID NCT06716606

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looks at the long-term safety and effectiveness of belimumab in adults with lung scarring (interstitial lung disease) caused by systemic sclerosis or other connective tissue diseases. About 514 people who completed earlier trials will receive belimumab for up to several years. Researchers will track side effects and measure how well the drug slows lung function decline and improves daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belimumab
What this could lead to
If successful, belimumab could offer a long-term treatment option to slow lung function decline and improve quality of life in people with connective tissue disease-related lung scarring.
What could go wrong
This is an open-label extension study, meaning everyone gets the drug and there is no placebo group, so results may be less definitive. Long-term safety is still being evaluated, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 514 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

connective tissue disorder diffuse scleroderma interstitial lung disease pulmonary systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Connective tissue diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 11201, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma de Buenos Aire, 1425, Argentina

  • GSK Investigational Site

    RECRUITING

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    RECRUITING

    Beijing, 100020, China

  • GSK Investigational Site

    RECRUITING

    Beijing, 100730, China

  • GSK Investigational Site

    RECRUITING

    Chengdu, 610072, China

  • GSK Investigational Site

    RECRUITING

    Hangzhou, 310052, China

  • GSK Investigational Site

    RECRUITING

    Mianyang, China

  • GSK Investigational Site

    RECRUITING

    Shanghai, 200001, China

  • GSK Investigational Site

    RECRUITING

    Shanghai, 200040, China

  • GSK Investigational Site

    RECRUITING

    Shenyang, 110001, China

  • GSK Investigational Site

    RECRUITING

    Zhuzhou, 412007, China

  • GSK Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • GSK Investigational Site

    RECRUITING

    Larissa, 41110, Greece

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, 546 42, Greece

  • GSK Investigational Site

    RECRUITING

    Poria – Neve Oved, Israel, 15208, Israel

  • GSK Investigational Site

    RECRUITING

    Aichi, 470-1192, Japan

  • GSK Investigational Site

    RECRUITING

    Gunma, 371-8511, Japan

  • GSK Investigational Site

    RECRUITING

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    RECRUITING

    Tokushima, 770-8503, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 113-8519, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 143-8541, Japan

  • GSK Investigational Site

    RECRUITING

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    RECRUITING

    Bucheon Kyunggi-Do, 420-717, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 04763, South Korea

  • GSK Investigational Site

    RECRUITING

    Suwon Kyunggi-do, 16499, South Korea

  • GSK Investigational Site

    RECRUITING

    Yongsan-Ku Seoul, South Korea

  • GSK Investigational Site

    RECRUITING

    Bilbao, Bizkaia, 48013, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    VigoPontevedra, 36200, Spain

  • GSK Investigational Site

    RECRUITING

    Leeds, LS7 4SA, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, NW3 2QG, United Kingdom

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