Systemic Sclerosis Associated Interstitial Lung DiseasePhase 2/3BLISSc-ILDNCT05878717

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

A Phase 2/3 study testing Belimumab in people with Systemic Sclerosis Associated Interstitial Lung Disease and Scleroderma, Systemic, run by GlaxoSmithKline at 134 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
What is being tested?: Belimumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 134 sitesin 18 countries
Study dates: 13 Sep 2023to 25 Oct 2029
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
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.
Total mRSS ≥15 on Day 1.
Evidence of interstitial lung disease on centrally read screening HRCT.
Anticentromere antibody negative on central test at screening.

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Evidence for active or progressive disease
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.
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 Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective.
Capable of giving signed informed consent.

Who cannot join

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).
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.
FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
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.

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Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7).
Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).
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.
Treatment with rituximab within 6 months prior to Day 1.
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.
Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
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.
Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.
Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

Trial locations and contacts

134 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Country

City, postcode or hospital

Sites recruiting now only

134 sites in 18 countries

United States26 sites, 22 recruiting

GSK Investigational Site
Ann Arbor, Michigan, 48109
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Aurora, Colorado, 80045
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Baltimore, Maryland, 21224
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Chicago, Illinois, 60611
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Cincinnati, Ohio, 45206
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Denison, Texas, 75020
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
El Paso, Texas, 79902
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Houston, Texas, 77030
Completed
GSK Investigational Site
Jacksonville, Florida, 32610
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Los Angeles, California, 90095
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Los Angeles, California, 90095
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Los Angeles, California, 90301
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Miami, Florida, 33144
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
New Brunswick, New Jersey, 08901
Completed
GSK Investigational Site
New York, New York, 10021
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
New York, New York, 11201
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Phoenix, Arizona, 85027
Completed
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Potsdam, New York, 13676
Completed
GSK Investigational Site
Scottsdale, Arizona, 85258
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Scottsdale, Arizona, 85259
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tucson, Arizona, 85724
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Upland, California, 91786
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Washington D.C., District of Columbia, 20007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in United States

China17 sites, 17 recruiting

GSK Investigational Site
Beijing, 100020
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Beijing, 100191
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Beijing, 100730
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Beijing, 100730
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Changchun, 130021
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Chengdu, 610041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Chengdu, 610072
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Luzhou, 648000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Mianyang
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Nanjing, 210008
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Nanjing, 210029
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Nanning, 530000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shanghai, 200001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shanghai, 200040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shenyang, 110001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Xi'an, 710061
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Zhuzhou, 412007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in China

Italy15 sites, 14 recruiting

GSK Investigational Site
Ancona, 60126
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bari, 70124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Cagliari, 09042
Withdrawn
GSK Investigational Site
Catania, 95123
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Ferrara, 44124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Florence, 50134
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Milan, 20122
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Modena, 41125
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Naples, 80131
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Orbassano to, 10043
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Padova, 35128
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Pavia, 27100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Roma, RM, 00161
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Roma, 00186
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Verona, 37134
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Italy

Japan9 sites, 7 recruiting

GSK Investigational Site
Gunma, 371-8511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hiroshima, 734-8551
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hokkaido, 060-8543
Withdrawn
GSK Investigational Site
Hokkaido, 060-8648
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Kanagawa, 236-0051
Withdrawn
GSK Investigational Site
Miyagi, 980-8574
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shizuoka, 431-3192
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tokushima, 770-8503
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tokyo, 113-8603
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Japan

Spain9 sites, 9 recruiting

GSK Investigational Site
Barcelona, 08025
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bilbao, 48013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Granada, 18016
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28046
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seville, 41013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Valencia, 46026
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
VigoPontevedra, 36200
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Spain

Brazil8 sites, 5 recruiting

GSK Investigational Site
Belo Horizonte, 30150221
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Curitiba, 80440-080
Completed
GSK Investigational Site
Juiz de Fora, 36010-570
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Porto Alegre, 90020-090
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Porto Alegre
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Salvador, 40.150-150
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
São Paulo, 01308-050
Completed
GSK Investigational Site
São Paulo, 04038-002
Completed

Other trials in Brazil

France6 sites, 6 recruiting

GSK Investigational Site
Bobigny, 93000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Brest, 29609
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Paris, 75014
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Paris, 75014
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Paris, 75651
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Toulouse, 31059
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in France

Israel6 sites, 4 recruiting

GSK Investigational Site
Haifa, 3436212
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Holon, 58100
Withdrawn
GSK Investigational Site
Kfar Saba, 44281
Withdrawn
GSK Investigational Site
Ramat Gan, 52621
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tel Aviv, 6423906
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tiberias, 15208
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Israel

Australia5 sites, 3 recruiting

GSK Investigational Site
Adelaide, South Australia, 5000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
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GSK Investigational Site
Camperdown, New South Wales, 2050
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GSK Investigational Site
Fitzroy, Victoria, 3065
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GSK Investigational Site
Liverpool, New South Wales, 2170
Completed
GSK Investigational Site
Woodville South, South Australia, 5011
Completed

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Germany5 sites, 5 recruiting

GSK Investigational Site
Cologne, 51149
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GSK Investigational Site
Düsseldorf, 40225
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GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
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GSK Investigational Site
Minden, North Rhine-Westphalia, 32429
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GSK Investigational Site
Tübingen, 72076
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Greece5 sites, 4 recruiting

GSK Investigational Site
Athens, 11527
Withdrawn
GSK Investigational Site
Athens, 12462
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GSK Investigational Site
Heraklion Crete, 71110
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GSK Investigational Site
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GSK Investigational Site
Thessaloniki, 546 36
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GSK Investigational Site
Chihuahua City, 31000
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GSK Investigational Site
Guadalajara, 44650
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GSK Investigational Site
Mérida, CP 97070
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GSK Investigational Site
Mexico City, 03310
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GSK Investigational Site
Torreón, 27000
Completed

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South Korea5 sites, 5 recruiting

GSK Investigational Site
Seoul, 04763
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GSK Investigational Site
Seoul, 05505
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GSK Investigational Site
Seoul, 06591
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GSK Investigational Site
Seoul, 140 887
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GSK Investigational Site
Suwon Kyunggi-do, 16499
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United Kingdom5 sites, 4 recruiting

GSK Investigational Site
Birmingham, B15 2GW
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GSK Investigational Site
Leeds, LS7 4SA
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GSK Investigational Site
London, NW3 2QG
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GSK Investigational Site
Portsmouth, SG1 4AB
Completed
GSK Investigational Site
Wakefield, West Yorkshire, WF1 4DG
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Argentina3 sites, 3 recruiting

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Buenos Aires
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GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO
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GSK Investigational Site
Ciudad Autonoma de Buenos Aire
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Belgium2 sites, 2 recruiting

GSK Investigational Site
Ghent, 9000
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GSK Investigational Site
Liège, 4000
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Recruiting

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Denmark2 sites

GSK Investigational Site
Aarhus N, Central Jutland, 8200
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GSK Investigational Site
Odense C, 5000
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Finland1 site

GSK Investigational Site
Turku, 20520
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About this study

Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Conditions: Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
Being tested: Belimumab, Placebo
Keywords: Monoclonal antibody, Autoimmune connective tissue disease, Skin, lung, systemic sclerosis, scleroderma, interstitial lung disease, belimumab
Medical subject headings: Scleroderma, Systemic, Scleroderma, Diffuse, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BelimumabBiological
Also called BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™
Belimumab will be administered.
PlaceboOther
.Placebo will be administered.

Study groups in NCT05878717
Study group	Role	What they receive
Belimumab	Experimental	Participants will receive belimumab in addition to standard therapy. Receives: Biological: Belimumab
Placebo	Placebo comparator	Participants will receive placebo in addition to standard therapy. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Measured: Baseline and Week 52

Secondary outcomes (22)

Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The assessment is made across 17 pre-defined areas of the body, with total score ranging between 0 and 51. Higher scores indicate worse skin thickening.
Measured: Baseline and Week 52
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including SSc. FACIT-Fatigue scores range from 0-52 (higher scores indicate less fatigue).
Measured: Baseline and Week 52
Time to Systemic sclerosis (SSc) progression or death
SSc progression or death is defined as the time when major organ-based complications develop, or the participant dies.
Measured: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Absolute change from baseline in FVC percentage (%) predicted at Week 52
Measured: Baseline and Week 52
Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
Measured: Baseline and Week 52
Relative decline from baseline in FVC (mL) ≥10% at Week 52
Measured: Baseline and Week 52
Absolute change from baseline in mRSS at Week 26
The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The assessment is made across 17 pre-defined areas of the body and therefore the total score can range from 0 to 51. Higher scores indicate worse skin thickening.
Measured: Baseline and Week 26
Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
Measured: At Week 26 and Week 52
Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
Measured: Baseline and Week 52
Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
Measured: Baseline and Week 52
Proportion of participants achieving ≥2% increase in QILD at Week 52
Measured: At Week 52
Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
Measured: Baseline and Week 52
Relative decline from baseline in DLco % predicted ≥15% at Week 52
Measured: Baseline and Week 52
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
The cough NRS enables the participant to rate their cough on a defined scale from 0 to 10, where higher score indicating worse cough symptoms.
Measured: Baseline and Week 52
Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
SSPRO a patient-reported outcome (PRO) instrument developed to assess the skin-related quality of life (QoL) in participants with SSc. SSPRO has 18 items that assess four SSc skin-related HRQoL domain (emotional effects, physical effects, physical limitations and social effects). The higher score indicates worse impact on QoL.
Measured: Baseline and Week 52
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
The HAQ-DI is a 26-question instrument assessing the degree of difficulty in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each question is scored 0-3 (where 0=without difficulty \& 3=unable to do). Higher scores reflect worse disability
Measured: Baseline and Week 52
Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
The SF-36 yields an 8-scale profile of functional health and well-being scores as well as physical and mental component health summary scores. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Baseline and Week 52
Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
PtGA is a patient reported outcome scale designed to capture the participants overall assessment of their disease. The participants are asked to score their disease on a scale from 0 to 10 where higher score indicates higher severity
Measured: Baseline and Week 52
Absolute change from baseline in Physician global assessment (PhGA) at Week 52
The PhGA is a score which enables the treating physician to rate the participants disease on a scale from 0 to 10, where higher score indicates greater severity.
Measured: Baseline and Week 52
Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
TDI assess dyspnea severity over 3 components: functional impairment, magnitude of task and magnitude of effort. Each component has 7 grades, ranging from -3 (major deterioration) to +3 (major improvement), which are summed to calculate a score, ranging between -9 and +9. The lower the score the more severely the participant is affected by dyspnea.
Measured: Baseline and Week 52
Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
Measured: Up to Week 52
Absolute change from baseline in DLco % predicted at Week 52
Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 202325 Oct 2029

First posted26 May 2023
Study start13 Sep 2023
Primary completion30 Aug 2029 (estimated)
Study completion25 Oct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Systemic Sclerosis Associated Interstitial Lung DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05878717
Sponsor's protocol ID: 218224
Other IDs: 2023-503219-14-01, 2023
Acronym: BLISSc-ILD
Status last verified: Sep 2026
First submitted: 19 May 2023
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

Lescoat A, Lecureur V, Gudjonsson JE, Khanna D. Systemic sclerosis: pathogenic mechanisms and their implications for treatment. Semin Immunopathol. 2025 Nov 11;47(1):39. doi: 10.1007/s00281-025-01065-6.
PubMed 41217519

Interested in taking part?

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 2
Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Systemic Sclerosis With Lung Involvement, Systemic Sclerosis
Active, not recruitingPhase 2
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
RecruitingPhase 3
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)
Connective Tissue Diseases
RecruitingObservational study
Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease
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All Systemic Sclerosis Associated Interstitial Lung Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)
ClinicalTrials.gov ID: NCT05878717
Acronym / sponsor ID: BLISSc-ILD / 218224
Conditions: Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
Keywords: Monoclonal antibody, Autoimmune connective tissue disease, Skin, lung, systemic sclerosis, scleroderma, interstitial lung disease, belimumab
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Sep 2023 (actual)
Primary completion: 30 Aug 2029 (estimated)
Study completion: 25 Oct 2029 (estimated)
First posted: 26 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Belimumab	Experimental	Biological: BelimumabParticipants will receive belimumab in addition to standard therapy.
Placebo	Placebo comparator	Other: PlaceboParticipants will receive placebo in addition to standard therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
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.
Total mRSS ≥15 on Day 1.
Evidence of interstitial lung disease on centrally read screening HRCT.

Key exclusion criteria (16 listed)

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).
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.
FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
SSc renal crisis within 6 months prior to the first day of dosing (Day 1).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BelimumabAlso: BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™Belimumab will be administered.	Biological	Belimumab
Placebo.Placebo will be administered.	Other	Placebo

Primary outcome

Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Time frame: Baseline and Week 52

22 secondary outcomes

Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
Time frame: Baseline and Week 52
Time to Systemic sclerosis (SSc) progression or death
Time frame: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Absolute change from baseline in FVC percentage (%) predicted at Week 52
Time frame: Baseline and Week 52
Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
Time frame: Baseline and Week 52
Relative decline from baseline in FVC (mL) ≥10% at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in mRSS at Week 26
Time frame: Baseline and Week 26
Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
Time frame: At Week 26 and Week 52
Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
Time frame: Baseline and Week 52
Proportion of participants achieving ≥2% increase in QILD at Week 52
Time frame: At Week 52
Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
Time frame: Baseline and Week 52
Relative decline from baseline in DLco % predicted ≥15% at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
Time frame: Baseline and Week 52
Absolute change from baseline in Physician global assessment (PhGA) at Week 52
Time frame: Baseline and Week 52
Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
Time frame: Baseline and Week 52
Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
Time frame: Up to Week 52
Absolute change from baseline in DLco % predicted at Week 52
Time frame: Baseline and Week 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Derived from this study: PubMed 41217519Lescoat A, Lecureur V, Gudjonsson JE, Khanna D. Systemic sclerosis: pathogenic mechanisms and their implications for treatment. Semin Immunopathol. 2025 Nov 11;47(1):39. doi: 10.1007/s00281-025-01065-6.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Related trials for Systemic Sclerosis Associated Interstitial Lung Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

134 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Belimumab in people with Systemic Sclerosis Associated Interstitial Lung Disease and Scleroderma, Systemic, run by GlaxoSmithKline at 134 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, China, Italy, Japan, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878717, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.