A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Belimumab
Biological/VaccineBelimumab will be administered.
Placebo
Other intervention.Placebo will be administered.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: BelimumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Time frame
Baseline and Week 52Secondary outcomes
1
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 522
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 523
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 Weeks4
Absolute change from baseline in FVC percentage (%) predicted at Week 52
Time frame
Baseline and Week 52Sponsors and contacts
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Source ClinicalTrials.gov