Interstitial Lung Disease Associated with Connective Tissue Disease
Conditions
Sponsors
Okamasa Arisa
Eligibility
Sex/Gender
All
Inclusion criteria
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), 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
Exclusion criteria
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 -10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or have 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 - Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose) at Week 52 - 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. | — |
Contacts
Public ContactArisa Okamasa
GlaxoSmithKline K.K.
Outcome results
None listed