A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (BEconneCTD-ILD)

JRCT ID: jRCT2011240027

Registered date:07/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Interstitial Lung Disease Associated with Connective Tissue Disease
• Date of first enrollment: 26/08/2024
• Target sample size: 440
• Study type: Interventional

Intervention(s)

Biological: Belimumab
Belimumab will be administered.
Other Name: BENLYSTA_trademark, GSK1550188, LymphoStat-B_trademark

Other: Placebo
Placebo will be administered.

Outcome(s)

• Primary Outcome: Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52.

Secondary Outcome

- Absolute Change from Baseline in FVC percent (%) Predicted At Week 52.
- Time to ILD progression or death
- Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52
- Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52
- Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
- Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
- Achieving Greater than or Equal (>-)2% Decrease in QILD-WL Score at Week 52.
- Achieving Relative Decline from Baseline in FVC (mL) >- 5 % at Week 52.
- Achieving Relative Decline from Baseline in FVC (mL) >- 10 % at Week 52
- Cumulative Dose of Corticosteroid over 52 Weeks
- Time to Connective Tissue Disease Progression
- Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52
- Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) atWeek 52
- Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52
- Absolute Change from Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) at Week 52
- Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52
- Absolute Change in Patient Global Impression of Change (PGIC)-ILD at week 52
- Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52.
- Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)
- Number of Participants with Respiratory Related Hospitalizations up to Week 52.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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), as confirmed by central reader at screening.
- 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 <1%
- Capable of giving signed informed consent

Exclude 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

Related Information

• Primary Sponsor: Okamasa Arisa
• Secondary ID(s): NCT06572384