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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06572384




Registration number
NCT06572384
Ethics application status
Date submitted
16/08/2024
Date registered
27/08/2024

Titles & IDs
Public title
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)
Secondary ID [1] 0 0
2024-513018-36
Secondary ID [2] 0 0
221672
Universal Trial Number (UTN)
Trial acronym
BEconneCTD-ILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
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) milliliter (mL) at Week 52
Assessment method [1] 0 0
Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52
Assessment method [1] 0 0
FVC are expressed as a percentage of the predicted normal for a person of the same sex, age, and height. Lower % predicted FVC (mL) reflects more impaired lung function.
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Time to ILD Progression or Death
Assessment method [2] 0 0
Time taken for a participant to experience ILD progression or death.
Timepoint [2] 0 0
From the date of assignment (Day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Secondary outcome [3] 0 0
Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52
Assessment method [3] 0 0
The FACIT-Fatigue is a short, 13-item questionnaire that assesses self-reported fatigue and its associated impact for daily activities over the past 7 days. The scale range is from 0 to 52, with 0 being the worst possible score and 52 being the best possible score (indicating less/no fatigue).
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [4] 0 0
Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52
Assessment method [4] 0 0
The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score the greater the impairment.
Timepoint [4] 0 0
Baseline and Week 52
Secondary outcome [5] 0 0
Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) at Week 52
Assessment method [5] 0 0
Change from baseline in extent of architectural distortion (fibrosis), ground glass opacification, and honeycombing features on High-resolution computed tomography (HRCT) as measured by computer-aided analysis tools. Extent of ILD is calculated by summing pixel counts and expressing this as a percentage of the whole lung. ILD extent can range from 0-100% with higher percentage representing more extensive ILD.
Timepoint [5] 0 0
Baseline and Week 52
Secondary outcome [6] 0 0
Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung at Week 52
Assessment method [6] 0 0
Change from baseline in extent of reticular patterns with architectural distortion (fibrosis) on HRCT as measured by computer-aided analysis tools. Extent of fibrosis is calculated by summing pixel counts and expressing this as a percentage of the whole lung. Fibrosis extent can range from 0-100% with higher percentage representing more extensive fibrosis.
Timepoint [6] 0 0
Baseline and Week 52
Secondary outcome [7] 0 0
Achieving Greater than or Equal (=) 2% Decrease in QILD-WL Score at Week 52
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Achieving Relative Decline from Baseline in FVC (mL) = 5% at Week 52
Assessment method [8] 0 0
Timepoint [8] 0 0
Baseline and Week 52
Secondary outcome [9] 0 0
Achieving Relative Decline from Baseline in FVC (mL) = 10 % at Week 52
Assessment method [9] 0 0
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Cumulative Dose of Corticosteroid over 52 Weeks
Assessment method [10] 0 0
Timepoint [10] 0 0
Up to Week 52
Secondary outcome [11] 0 0
Time to Connective Tissue Disease Progression
Assessment method [11] 0 0
Time taken for a participant to experience CTD progression.
Timepoint [11] 0 0
Up to 52 Weeks
Secondary outcome [12] 0 0
Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52
Assessment method [12] 0 0
TDI assess dyspnea severity at baseline and its change over time. TDI includes 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. Lower score indicates more severely the participant is affected by dyspnea.
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) at Week 52
Assessment method [13] 0 0
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 (0) the more disability.
Timepoint [13] 0 0
Baseline and Week 52
Secondary outcome [14] 0 0
Absolute Change from Baseline in Living with. Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52
Assessment method [14] 0 0
The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score (100) the greater the impairment.
Timepoint [14] 0 0
Baseline and Week 52
Secondary outcome [15] 0 0
Absolute Change from Baseline in Kings Brief. Interstitial Lung Disease Questionnaire (K-BILD) at Week 52
Assessment method [15] 0 0
The King's Brief Interstitial Lung Disease (K- ILD) questionnaire consists of 15 items (assessed by the patients on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34) , and chest symptoms (range: 0-8). Scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status). A total score and 3 domain scores are calculated ranging from 0-100 with greater scores (100) denoting better quality of life.
Timepoint [15] 0 0
Baseline and Week 52
Secondary outcome [16] 0 0
Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52
Assessment method [16] 0 0
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 (10) indicates greater severity.
Timepoint [16] 0 0
Baseline and Week 52
Secondary outcome [17] 0 0
Absolute Change in Patient Global Impression of Change (PGIC)-ILD at Week 52
Assessment method [17] 0 0
The PGIC contains two items, a global question asking participants to rate their overall change in ILD severity since first starting this study using a 7-point verbal rating scale, and a yes/no question asking participants to indicate whether the change is meaningful from their perspective.
Timepoint [17] 0 0
Baseline and Week 52
Secondary outcome [18] 0 0
Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52
Assessment method [18] 0 0
Timepoint [18] 0 0
Baseline and Week 52
Secondary outcome [19] 0 0
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)
Assessment method [19] 0 0
Timepoint [19] 0 0
Up to Week 60
Secondary outcome [20] 0 0
Number of Participants with Respiratory Related Hospitalizations up to Week 52
Assessment method [20] 0 0
Timepoint [20] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
* 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 ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (=) 10% of the whole lung (WLILD)
* Evidence of ILD progression in the previous 24 months
* Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate first line 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 hospitalisation).
* FVC = 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) = 40% of predicted or requiring supplemental oxygen at screening
* History or presence of diffuse alveolar haemorrhage (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).
* Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD)
* Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
* Have evidence of moderate to severe depression, defined as PHQ-9 score =10, or serious current suicide risk, 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

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
11/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/12/2028
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
6163 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autonoma de Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Argentina
State/province [6] 0 0
Mendoza
Country [7] 0 0
Argentina
State/province [7] 0 0
Rosario
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chengdu
Country [12] 0 0
China
State/province [12] 0 0
Guangzhou
Country [13] 0 0
China
State/province [13] 0 0
Mianyang
Country [14] 0 0
China
State/province [14] 0 0
Nanning
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Suzhou
Country [17] 0 0
China
State/province [17] 0 0
ZhuZhou
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Greece
State/province [20] 0 0
Larissa
Country [21] 0 0
Italy
State/province [21] 0 0
Ancona
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Japan
State/province [24] 0 0
Aichi
Country [25] 0 0
Japan
State/province [25] 0 0
Fukuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Hiroshima
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Kanagawa
Country [29] 0 0
Japan
State/province [29] 0 0
Miyagi
Country [30] 0 0
Japan
State/province [30] 0 0
Miyazaki
Country [31] 0 0
Japan
State/province [31] 0 0
Saitama
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Japan
State/province [33] 0 0
Tottori
Country [34] 0 0
Japan
State/province [34] 0 0
Yamanashi
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Bucheon Kyunggi-Do
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Suwon Kyunggi-do
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Yongsan-Ku Seoul
Country [39] 0 0
Netherlands
State/province [39] 0 0
Rotterdam
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Pamplona

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 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
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement


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/NCT06572384