Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as.
Diagnosis by a rheumatologist with 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or Mixed connective tissue disease (MCTD).
Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent >10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review.
No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria.
No improvement in absolute forced vital capacity (FVC) % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart.
No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator).
FVC ≥45% of predicted normal at Visit 1.
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1.
Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) with the following specifications.
If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2.
If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2.
If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2.
In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned.
Further inclusion criteria apply.
Organising pneumonia as predominant pattern in the HRCT.
Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1.
Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement.
Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period.
Any suicidal behaviour in the past 2 years.
Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2.
Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1.
Further exclusion criteria apply.
Sites
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Vasco de Quiroga 15, Belisario Domínguez Secc 16, 14080 Ciudad de México
Hospital Universitario Dr. José Eleuterio González
Av. Dr. José Eleuterio González, Mitras Centro, 64460 Monterrey, N.L., Mexico
Investigación y Biomedicina de Chihuahua
Calle 16, 1600, Zona Centro, 31000 Chihuahua, Chih., México
Medical Care & Research SA de CV
Calle 32 217 por Calle 11 y 13, Colonia Garcia Gineres, CP 97070 - Yucatán, Mérida
SOLTMED SMO
Monte Alban 599, Col. Letrán Valle, Benito Juárez, 03650, Ciudad de México, México
Clínica para el Diagnostico y Tratamiento de las Enfermedades Reumáticas - CITER
Calle de Durango 69, Roma Nte., Cuauhtémoc, 06700 Ciudad de México, CDMX
Centro Integral en Reumatología S.A. de C.V. - CIRSA
Av. de la Paz 1919, Col Americana, Americana, 44150 Guadalajara, Jal., Mexico