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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05878717




Registration number
NCT05878717
Ethics application status
Date submitted
19/05/2023
Date registered
26/05/2023

Titles & IDs
Public title
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Scientific 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)
Secondary ID [1] 0 0
EU CT Number
Secondary ID [2] 0 0
218224
Universal Trial Number (UTN)
Trial acronym
BLISSc-ILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Sclerosis Associated Interstitial Lung Disease 0 0
Scleroderma, Systemic 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Belimumab
Other interventions - Placebo

Experimental: Belimumab - Participants will receive belimumab in addition to standard therapy.

Placebo comparator: Placebo - Participants will receive placebo in addition to standard therapy.


Treatment: Other: Belimumab
Belimumab will be administered.

Other interventions: Placebo
.Placebo will be administered.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
Timepoint [2] 0 0
Baseline and Week 52
Secondary outcome [3] 0 0
Time to Systemic sclerosis (SSc) progression or death
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Absolute change from baseline in FVC percentage (%) predicted at Week 52
Timepoint [4] 0 0
Baseline and Week 52
Secondary outcome [5] 0 0
Relative decline from baseline in FVC (mL) greater than or equal to (=)5% at Week 52
Timepoint [5] 0 0
Baseline and Week 52
Secondary outcome [6] 0 0
Relative decline from baseline in FVC (mL) =10% at Week 52
Timepoint [6] 0 0
Baseline and Week 52
Secondary outcome [7] 0 0
Absolute change from baseline in mRSS at Week 26
Timepoint [7] 0 0
Baseline and Week 26
Secondary outcome [8] 0 0
Proportion of participants achieving =20% increase in mRSS at Week 26 & 52
Timepoint [8] 0 0
At Week 26 and Week 52
Secondary outcome [9] 0 0
Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
Timepoint [10] 0 0
Baseline and Week 52
Secondary outcome [11] 0 0
Proportion of participants achieving =2% increase in QILD at Week 52
Timepoint [11] 0 0
At Week 52
Secondary outcome [12] 0 0
Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Relative decline from baseline in DLco % predicted =15% at Week 52
Timepoint [13] 0 0
Baseline and Week 52
Secondary outcome [14] 0 0
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
Timepoint [14] 0 0
Baseline and Week 52
Secondary outcome [15] 0 0
Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
Timepoint [15] 0 0
Baseline and Week 52
Secondary outcome [16] 0 0
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Timepoint [16] 0 0
Baseline and Week 52
Secondary outcome [17] 0 0
Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
Timepoint [17] 0 0
Baseline and Week 52
Secondary outcome [18] 0 0
Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
Timepoint [18] 0 0
Baseline and Week 52
Secondary outcome [19] 0 0
Absolute change from baseline in Physician global assessment (PhGA) at Week 52
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
Timepoint [20] 0 0
Baseline and Week 52
Secondary outcome [21] 0 0
Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
Timepoint [21] 0 0
Up to Week 52
Secondary outcome [22] 0 0
Absolute change from baseline in DLco % predicted at Week 52
Timepoint [22] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1.
4. Total mRSS =15 on Day 1.
5. Evidence of interstitial lung disease on centrally read screening HRCT.
6. Anticentromere antibody negative on central test at screening.
7. Evidence for active or progressive disease
8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.
9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study.
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

Is a Woman of Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective.
11. Capable of giving signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic systemic fibrosis], or due to metabolic disease).
2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator.
3. FVC =45% of predicted, or a DLco (corrected for hemoglobin) =40% of predicted or requiring supplemental oxygen at screening.
4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7).
8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).
10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing.
11. Treatment with rituximab within 6 months prior to Day 1.
12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1.
13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1.
15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.
16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [3] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [4] 0 0
GSK Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma Buenos Aires
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Brazil
State/province [18] 0 0
Bahía
Country [19] 0 0
Brazil
State/province [19] 0 0
Minas Gerais
Country [20] 0 0
Brazil
State/province [20] 0 0
Paraná
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio Grande Do Sul
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
China
State/province [24] 0 0
Guangxi
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Jilin
Country [28] 0 0
China
State/province [28] 0 0
Sichuan
Country [29] 0 0
China
State/province [29] 0 0
Beijing
Country [30] 0 0
China
State/province [30] 0 0
Luzhou
Country [31] 0 0
China
State/province [31] 0 0
Mianyang
Country [32] 0 0
China
State/province [32] 0 0
Nanjing
Country [33] 0 0
China
State/province [33] 0 0
Shanghai
Country [34] 0 0
China
State/province [34] 0 0
Shenyang
Country [35] 0 0
China
State/province [35] 0 0
Xian
Country [36] 0 0
Denmark
State/province [36] 0 0
Aarhus
Country [37] 0 0
Denmark
State/province [37] 0 0
Køge
Country [38] 0 0
Denmark
State/province [38] 0 0
Odense C
Country [39] 0 0
Finland
State/province [39] 0 0
Turku
Country [40] 0 0
France
State/province [40] 0 0
Bobigny
Country [41] 0 0
France
State/province [41] 0 0
Paris Cedex 13
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Strasbourg
Country [44] 0 0
France
State/province [44] 0 0
Toulouse cedex 9
Country [45] 0 0
Germany
State/province [45] 0 0
Baden-Wuerttemberg
Country [46] 0 0
Germany
State/province [46] 0 0
Nordrhein-Westfalen
Country [47] 0 0
Germany
State/province [47] 0 0
Bad Abbach
Country [48] 0 0
Greece
State/province [48] 0 0
Attiki
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
Country [50] 0 0
Greece
State/province [50] 0 0
Heraklion-Crete
Country [51] 0 0
Greece
State/province [51] 0 0
Larissa
Country [52] 0 0
Greece
State/province [52] 0 0
Thessaloniki
Country [53] 0 0
Israel
State/province [53] 0 0
Haifa
Country [54] 0 0
Israel
State/province [54] 0 0
Kfar Saba
Country [55] 0 0
Israel
State/province [55] 0 0
Tel Aviv
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Hashomer
Country [57] 0 0
Israel
State/province [57] 0 0
Tiberias
Country [58] 0 0
Italy
State/province [58] 0 0
Emilia-Romagna
Country [59] 0 0
Italy
State/province [59] 0 0
Lazio
Country [60] 0 0
Italy
State/province [60] 0 0
Lombardia
Country [61] 0 0
Italy
State/province [61] 0 0
Marche
Country [62] 0 0
Italy
State/province [62] 0 0
Piemonte
Country [63] 0 0
Italy
State/province [63] 0 0
Puglia
Country [64] 0 0
Italy
State/province [64] 0 0
Sardegna
Country [65] 0 0
Italy
State/province [65] 0 0
Sicilia
Country [66] 0 0
Italy
State/province [66] 0 0
Veneto
Country [67] 0 0
Italy
State/province [67] 0 0
Firenze
Country [68] 0 0
Italy
State/province [68] 0 0
Napoli
Country [69] 0 0
Italy
State/province [69] 0 0
Verona
Country [70] 0 0
Japan
State/province [70] 0 0
Gunma
Country [71] 0 0
Japan
State/province [71] 0 0
Hokkaido
Country [72] 0 0
Japan
State/province [72] 0 0
Kanagawa
Country [73] 0 0
Japan
State/province [73] 0 0
Miyagi
Country [74] 0 0
Japan
State/province [74] 0 0
Tokyo
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Suwon-si, Gyeonggi-do
Country [77] 0 0
Mexico
State/province [77] 0 0
Ciudad De Mexico
Country [78] 0 0
Mexico
State/province [78] 0 0
Coahuila
Country [79] 0 0
Mexico
State/province [79] 0 0
Jalisco
Country [80] 0 0
Mexico
State/province [80] 0 0
Yucatán
Country [81] 0 0
Mexico
State/province [81] 0 0
Chihuahua
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Bilbao
Country [84] 0 0
Spain
State/province [84] 0 0
Granada
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Spain
State/province [87] 0 0
Valencia
Country [88] 0 0
Spain
State/province [88] 0 0
Vigo/ Pontevedra
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Edgbaston
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Leeds
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05878717