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Could a lupus drug help scleroderma lungs?

NCT ID NCT05878717

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests whether belimumab (Benlysta), a drug already used for lupus, can improve lung function and skin thickening in adults with scleroderma-related interstitial lung disease. About 300 participants will receive either belimumab or a placebo added to their standard care. The main goal is to see if lung capacity changes after one year.

What this could mean

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

Active substance
belimumab (Benlysta)
What this could lead to
If it works, this could offer a new treatment option to slow lung damage and improve skin and quality of life in people with scleroderma-related lung disease.
What could go wrong
This is a mid-stage trial, so results are uncertain. Belimumab may not improve lung function more than placebo, and side effects like infections are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

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

Started

Sep 2023

Expected to finish

Oct 2029

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: 1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent. 2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria. 3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \>0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1. 4. Total mRSS ≥15 on Day 1. 5. Evidence of interstitial lung disease on centrally read screening HRCT. 6. Anticentromere antibody negative on central test at screening. 7. Evidence for active or progressive disease 8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh. 9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study. 10. 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. 11. Capable of giving signed informed consent. Exclusion Criteria: 1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \[nephrogenic systemic fibrosis\], or due to metabolic disease). 2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator. 3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening. 4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1). 5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1). 6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. 7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC \<0.7). 8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD). 9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant). 10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing. 11. Treatment with rituximab within 6 months prior to Day 1. 12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1. 13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1. 14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1. 15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1. 16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma interstitial lung disease pulmonary systemic sclerosis systemic sclerosis

As listed by the trial registrant

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

Scleroderma, systemic Systemic sclerosis associated interstitial lung disease

How to take part

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

  1. The places running it

    114 sites in 16 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

    COMPLETED

    Phoenix, Arizona, 85027, United States

  • GSK Investigational Site

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • GSK Investigational Site

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • GSK Investigational Site

    RECRUITING

    Tucson, Arizona, 85724, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90301, United States

  • GSK Investigational Site

    RECRUITING

    Upland, California, 91786, United States

  • GSK Investigational Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • GSK Investigational Site

    RECRUITING

    Jacksonville, Florida, 32610, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33144, United States

  • GSK Investigational Site

    RECRUITING

    Chicago, Illinois, 60611, United States

  • GSK Investigational Site

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • GSK Investigational Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • GSK Investigational Site

    COMPLETED

    New Brunswick, New Jersey, 08901, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10021, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 11201, United States

  • GSK Investigational Site

    COMPLETED

    Potsdam, New York, 13676, United States

  • GSK Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45206, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • GSK Investigational Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • GSK Investigational Site

    RECRUITING

    Denison, Texas, 75020, United States

  • GSK Investigational Site

    RECRUITING

    El Paso, Texas, 79902, United States

  • GSK Investigational Site

    COMPLETED

    Houston, Texas, 77030, United States

  • 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, Argentina

  • GSK Investigational Site

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • GSK Investigational Site

    COMPLETED

    Liverpool, New South Wales, 2170, Australia

  • GSK Investigational Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • GSK Investigational Site

    COMPLETED

    Woodville South, South Australia, 5011, Australia

  • GSK Investigational Site

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    RECRUITING

    Ghent, 9000, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Belo Horizonte, 30150221, Brazil

  • GSK Investigational Site

    COMPLETED

    Curitiba, 80440-080, Brazil

  • GSK Investigational Site

    RECRUITING

    Juiz de Fora, 36010-570, Brazil

  • GSK Investigational Site

    RECRUITING

    Porto Alegre, 90020-090, Brazil

  • GSK Investigational Site

    RECRUITING

    Porto Alegre, Brazil

  • GSK Investigational Site

    RECRUITING

    Salvador, 40.150-150, Brazil

  • GSK Investigational Site

    COMPLETED

    São Paulo, 01308-050, Brazil

  • GSK Investigational Site

    COMPLETED

    São Paulo, 04038-002, Brazil

  • GSK Investigational Site

    RECRUITING

    Beijing, 100020, China

  • GSK Investigational Site

    RECRUITING

    Beijing, 100191, China

  • GSK Investigational Site

    RECRUITING

    Beijing, 100730, China

  • GSK Investigational Site

    RECRUITING

    Beijing, 100730, China

  • GSK Investigational Site

    RECRUITING

    Changchun, 130021, China

  • GSK Investigational Site

    RECRUITING

    Chengdu, 610041, China

  • GSK Investigational Site

    RECRUITING

    Chengdu, 610072, China

  • GSK Investigational Site

    RECRUITING

    Luzhou, 648000, China

  • GSK Investigational Site

    RECRUITING

    Mianyang, China

  • GSK Investigational Site

    RECRUITING

    Nanjing, 210008, China

  • GSK Investigational Site

    RECRUITING

    Nanjing, 210029, China

  • GSK Investigational Site

    RECRUITING

    Nanning, 530000, 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

    Xi'an, 710061, China

  • GSK Investigational Site

    RECRUITING

    Zhuzhou, 412007, China

  • GSK Investigational Site

    WITHDRAWN

    Aarhus N, Central Jutland, 8200, Denmark

  • GSK Investigational Site

    WITHDRAWN

    Odense C, 5000, Denmark

  • GSK Investigational Site

    WITHDRAWN

    Turku, 20520, Finland

  • GSK Investigational Site

    RECRUITING

    Bobigny, 93000, France

  • GSK Investigational Site

    RECRUITING

    Brest, 29609, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75014, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75014, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75651, France

  • GSK Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • GSK Investigational Site

    RECRUITING

    Minden, North Rhine-Westphalia, 32429, Germany

  • GSK Investigational Site

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • GSK Investigational Site

    RECRUITING

    Cologne, 51149, Germany

  • GSK Investigational Site

    RECRUITING

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    RECRUITING

    Tübingen, 72076, Germany

  • GSK Investigational Site

    WITHDRAWN

    Athens, 11527, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 12462, Greece

  • GSK Investigational Site

    RECRUITING

    Heraklion Crete, 71110, Greece

  • GSK Investigational Site

    RECRUITING

    Larissa, 41110, Greece

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, 546 36, Greece

  • GSK Investigational Site

    RECRUITING

    Haifa, 3436212, Israel

  • GSK Investigational Site

    WITHDRAWN

    Holon, 58100, Israel

  • GSK Investigational Site

    WITHDRAWN

    Kfar Saba, 44281, Israel

  • GSK Investigational Site

    RECRUITING

    Ramat Gan, 52621, Israel

  • GSK Investigational Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • GSK Investigational Site

    RECRUITING

    Tiberias, 15208, Israel

  • GSK Investigational Site

    RECRUITING

    Roma, RM, 00161, Italy

  • GSK Investigational Site

    RECRUITING

    Ancona, 60126, Italy

  • GSK Investigational Site

    RECRUITING

    Bari, 70124, Italy

  • GSK Investigational Site

    WITHDRAWN

    Cagliari, 09042, Italy

  • GSK Investigational Site

    RECRUITING

    Catania, 95123, Italy

  • GSK Investigational Site

    RECRUITING

    Ferrara, 44124, Italy

  • GSK Investigational Site

    RECRUITING

    Florence, 50134, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20122, Italy

  • GSK Investigational Site

    RECRUITING

    Modena, 41125, Italy

  • GSK Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • GSK Investigational Site

    RECRUITING

    Orbassano to, 10043, Italy

  • GSK Investigational Site

    RECRUITING

    Padova, 35128, Italy

  • GSK Investigational Site

    RECRUITING

    Pavia, 27100, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00186, Italy

  • GSK Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • GSK Investigational Site

    RECRUITING

    Gunma, 371-8511, Japan

  • GSK Investigational Site

    RECRUITING

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    WITHDRAWN

    Hokkaido, 060-8543, Japan

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    WITHDRAWN

    Kanagawa, 236-0051, Japan

  • GSK Investigational Site

    RECRUITING

    Miyagi, 980-8574, Japan

  • GSK Investigational Site

    RECRUITING

    Shizuoka, 431-3192, Japan

  • GSK Investigational Site

    RECRUITING

    Tokushima, 770-8503, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

    RECRUITING

    Chihuahua City, 31000, Mexico

  • GSK Investigational Site

    RECRUITING

    Guadalajara, 44650, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 03310, Mexico

  • GSK Investigational Site

    RECRUITING

    Mérida, CP 97070, Mexico

  • GSK Investigational Site

    COMPLETED

    Torreón, 27000, Mexico

  • GSK Investigational Site

    RECRUITING

    Seoul, 04763, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 05505, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06591, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 140 887, South Korea

  • GSK Investigational Site

    RECRUITING

    Suwon Kyunggi-do, 16499, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08025, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Bilbao, 48013, Spain

  • GSK Investigational Site

    RECRUITING

    Granada, 18016, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • GSK Investigational Site

    RECRUITING

    Seville, 41013, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46026, Spain

  • GSK Investigational Site

    RECRUITING

    VigoPontevedra, 36200, Spain

  • GSK Investigational Site

    RECRUITING

    Wakefield, West Yorkshire, WF1 4DG, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Leeds, LS7 4SA, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, NW3 2QG, United Kingdom

  • GSK Investigational Site

    COMPLETED

    Portsmouth, SG1 4AB, United Kingdom

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