ClinicaliQ Trial Snapshot
- A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06572384.
- What is being tested: Belimumab, a monoclonal antibody targeting B-lymphocyte stimulator (BLyS), is being evaluated for its efficacy and safety in treating interstitial lung disease (ILD) associated with connective tissue diseases—a condition characterised by lung inflammation and fibrosis.
- Patient eligibility overview: The trial enrolls adults with confirmed ILD secondary to connective tissue disease who meet specific pulmonary function and radiological criteria; participants typically have documented CTD diagnoses (such as systemic sclerosis, rheumatoid arthritis, or mixed CTD) with symptomatic or progressive….
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What This Trial Is Studying
Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an…
Eligibility Snapshot
- : * Participants with persistent/worsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy. * 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 inflammatory and/or fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung * Evidence of persistent active/worsening ILD * Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.