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New hope for stiff lungs? drug trial targets scarring from autoimmune disease

NCT ID NCT06572384

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether belimumab (Benlysta) can stabilize or improve lung function in adults with interstitial lung disease caused by connective tissue diseases like rheumatoid arthritis or lupus. About 440 participants will receive either belimumab injections or a placebo, plus standard therapy, for a year. The main goal is to see if the drug helps preserve lung capacity and ease symptoms.

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 or improve lung damage in people with connective tissue disease-related interstitial lung disease.
What could go wrong
This is a phase 3 trial, but results may not show benefit over placebo. Belimumab also carries risks like infections and allergic reactions.

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 440 people

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

Started

Sep 2024

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: * Participants with persistent/worsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy. * Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria * Diagnosis of inflammatory and/or fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung * Evidence of persistent active/worsening ILD * Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate standard therapy. * 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 * 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 nonchildbearing 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% * Capable of giving signed informed consent Exclusion Criteria: * Diagnosis of ILD other than CTD-ILD. * Primary diagnosis of Systemic Sclerosis (SSc). * Participants with rapidly progressive disease (absolute drop of 10% or more of FVC between screening and baseline visit and/or recent pulmonary hospitalization). * FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted at screening as confirmed by central reader * History or presence of diffuse alveolar hemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms * Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1) * Dependence on continuous oxygen supplementation * 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 * Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC \<0.7) as confirmed by central reader * Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD) as confirmed by central reader * Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms * Participants with patient health questionnaire (PHQ-9) score ≥10, that in the opinion of a mental healthcare professional pose a serious suicide risk, have or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Breast cancer within the past 10 years * Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study * An active infection, or a history of infections

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Conditions

The condition(s) this trial relates to.

antisynthetase syndrome autoimmune disease connective tissue disorder dermatomyositis idiopathic inflammatory myopathy interstitial lung disease lung disorder mixed connective tissue disease polymyositis rheumatoid arthritis Sjogren syndrome systemic lupus erythematosus

As listed by the trial registrant

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

Lung diseases, interstitial

How to take part

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

  1. The places running it

    126 sites in 18 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, 90033, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    RECRUITING

    Orange, California, 92868-3201, United States

  • GSK Investigational Site

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    San Francisco, California, 94143, United States

  • GSK Investigational Site

    RECRUITING

    Upland, California, 91786, United States

  • GSK Investigational Site

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    Gainesville, Florida, 32608, United States

  • GSK Investigational Site

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    Naples, Florida, 34102, United States

  • GSK Investigational Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10021, United States

  • GSK Investigational Site

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    New York, New York, 10029, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10032, United States

  • GSK Investigational Site

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    Potsdam, New York, 13676, United States

  • GSK Investigational Site

    RECRUITING

    Durham, North Carolina, 27710-4000, United States

  • GSK Investigational Site

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    Philadelphia, Pennsylvania, 19140, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030-2348, United States

  • GSK Investigational Site

    RECRUITING

    Temple, Texas, 76508, United States

  • GSK Investigational Site

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1128AAF, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

  • GSK Investigational Site

    RECRUITING

    Córdoba, X5000AAW, Argentina

  • GSK Investigational Site

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    Mendoza, 5500, Argentina

  • GSK Investigational Site

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    Rosario, S2002, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000, Argentina

  • GSK Investigational Site

    RECRUITING

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    RECRUITING

    Spearwood, Western Australia, 6163, Australia

  • GSK Investigational Site

    RECRUITING

    Brussels, 1090, Belgium

  • GSK Investigational Site

    RECRUITING

    Brussels, 1200, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Namur, Belgium

  • GSK Investigational Site

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • GSK Investigational Site

    RECRUITING

    Barra Mansa, 27323240, 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, 90480000, Brazil

  • GSK Investigational Site

    RECRUITING

    São Paulo, 04004-030, Brazil

  • GSK Investigational Site

    RECRUITING

    São Paulo, 05403-900, Brazil

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    WITHDRAWN

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • 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

    Guangzhou, 510100, China

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510630, China

  • GSK Investigational Site

    RECRUITING

    Hangzhou, 310003, China

  • GSK Investigational Site

    RECRUITING

    Hangzhou, 310052, 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

    Suzhou, China

  • GSK Investigational Site

    RECRUITING

    Tianjin, 300052, China

  • GSK Investigational Site

    RECRUITING

    Zhuzhou, 412007, China

  • GSK Investigational Site

    RECRUITING

    Angers, 49933, France

  • GSK Investigational Site

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • GSK Investigational Site

    RECRUITING

    Lille, 59037, France

  • GSK Investigational Site

    RECRUITING

    Pessac, 33604, France

  • GSK Investigational Site

    RECRUITING

    Rouen, 76000, France

  • GSK Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • GSK Investigational Site

    RECRUITING

    Essen, North Rhine-Westphalia, 45239, Germany

  • GSK Investigational Site

    RECRUITING

    Minden, North Rhine-Westphalia, 32429, Germany

  • GSK Investigational Site

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • GSK Investigational Site

    RECRUITING

    Würzburg, 97080, Germany

  • GSK Investigational Site

    RECRUITING

    Athens, 106 76, Greece

  • GSK Investigational Site

    WITHDRAWN

    Athens, 124 62, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 12462, Greece

  • GSK Investigational Site

    RECRUITING

    Larissa, 41110, Greece

  • GSK Investigational Site

    RECRUITING

    Ancona, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20132, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, Italy

  • GSK Investigational Site

    RECRUITING

    Modena, 41124, Italy

  • GSK Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • GSK Investigational Site

    RECRUITING

    Padova, Italy

  • GSK Investigational Site

    RECRUITING

    Palermo, 90127, Italy

  • GSK Investigational Site

    RECRUITING

    Pavia, 27100, Italy

  • GSK Investigational Site

    RECRUITING

    Pisa, 56126, Italy

  • GSK Investigational Site

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    Roma, 00128, Italy

  • GSK Investigational Site

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    Roma, Italy

  • GSK Investigational Site

    RECRUITING

    Udine, 33100, Italy

  • GSK Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • GSK Investigational Site

    RECRUITING

    Aichi, 470-1192, Japan

  • GSK Investigational Site

    RECRUITING

    Fukuoka, 807-8556, Japan

  • GSK Investigational Site

    RECRUITING

    Fukuoka, 812-8582, Japan

  • GSK Investigational Site

    RECRUITING

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    RECRUITING

    Kanagawa, 216-8511, Japan

  • GSK Investigational Site

    RECRUITING

    Miyagi, 983-8512, Japan

  • GSK Investigational Site

    RECRUITING

    Miyazaki, 889-1692, Japan

  • GSK Investigational Site

    RECRUITING

    Saitama, 350-0495, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 113-8519, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

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    Tokyo, 143-8541, Japan

  • GSK Investigational Site

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    Tottori, 683-8504, Japan

  • GSK Investigational Site

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    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

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    Chihuahua City, 31000, Mexico

  • GSK Investigational Site

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    Guadalajara, 44650, Mexico

  • GSK Investigational Site

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    Mexicali, 21200, Mexico

  • GSK Investigational Site

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    Mexico City, 03310, Mexico

  • GSK Investigational Site

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    Mérida, CP 97070, Mexico

  • GSK Investigational Site

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    Monterrey, 64460, Mexico

  • GSK Investigational Site

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • GSK Investigational Site

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    COMPLETED

    Panama City, 07126, Panama

  • GSK Investigational Site

    RECRUITING

    Panama City, 7002, Panama

  • GSK Investigational Site

    RECRUITING

    Panama City, 7099, Panama

  • GSK Investigational Site

    RECRUITING

    Panama City, Panama

  • GSK Investigational Site

    RECRUITING

    Panama City, Panama

  • GSK Investigational Site

    RECRUITING

    Bucheon Kyunggi-Do, 420-717, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 05505, South Korea

  • GSK Investigational Site

    WITHDRAWN

    Seoul, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06591, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 3080, South Korea

  • GSK Investigational Site

    RECRUITING

    Suwon Kyunggi-do, 443-721, South Korea

  • GSK Investigational Site

    WITHDRAWN

    Yongsan-Ku Seoul, South Korea

  • GSK Investigational Site

    RECRUITING

    Pamplona Iruna, Navarre, 31008, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08025, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Córdoba, 14004, Spain

  • GSK Investigational Site

    WITHDRAWN

    Granada, 18016, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29530, Spain

  • GSK Investigational Site

    RECRUITING

    Santander, 39011, Spain

  • GSK Investigational Site

    RECRUITING

    Seville, 41013, Spain

  • GSK Investigational Site

    RECRUITING

    Leicester, Leicestershire, LE3 9QP, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, SW3 6NP, United Kingdom

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