A Phase 2/3 interventional study of Belimumab and Placebo in Systemic Sclerosis Associated Interstitial Lung Disease and Scleroderma, Systemic, sponsored by GlaxoSmithKline. Recruiting at 134 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by GlaxoSmithKline · Phase 2/3, Interventional, and Treatment
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).
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 300 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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- (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a method that is highly effective.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive belimumab in addition to standard therapy.
Biological: Belimumab
Participants will receive placebo in addition to standard therapy.
Other: Placebo
Belimumab will be administered.
Also known as: BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™
.Placebo will be administered.
Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Time frame: Baseline and Week 52
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.
Time frame: 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).
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
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Studies of the drug tested here: Belimumab