A multicenter, randomized, double-blind, parallel, placebo-controlled phase 2 trial is set to evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis (IPF).
The primary outcome measure of the trial is change from baseline in forced vital capacity (FVC) percent predicted value to week 24. Secondary outcome measures include change from baseline in FVC (L) to week 4, 8, 12, 16, 20, and 24; change from baseline in FVC percent predicted value to week 4, 8, 12, 16, and 20; change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO) and St. George’s Respiratory Questionnaire score to week 12 and week 24; and number of participants with an acute exacerbation of IPF, all-cause mortality, adverse events, serum concentration of SHR-1906, and proportion of anti-SHR-1906 antibody formed during the study from treatment initiation to the end of the trial (approximately 28 weeks).
The trial consists of 4 stages: screening, baseline, treatment, and follow-up. It will enroll 108 participants, aged 40 to 80 years at the time of screening, who were diagnosed with IPF according to the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines (2022 update).
Participants must have an FVC percent predicted value between 45% and 90% (inclusive) at screening and at the first day of treatment and a DLCO percent predicted value between 30% and 90% (inclusive) at screening. Moreover, specific criteria apply to patients receiving pirfenidone or nidanib.
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Patients with interstitial lung disease other than IPF, as well as patients with history of other types of respiratory disease that might interfere with the primary endpoint of the study or affect patient participation in any form are excluded from the trial. In addition, the trial excludes patients whose ratio of forced expiratory volume/FVC at the first second is lower than 0.70 (after using a bronchodilator) or those presenting with emphysema greater than fibrosis.
The trial, which is not yet recruiting, is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd.
Study on intravenous injection of SHR-1906 in the treatment of idiopathic pulmonary fibrosis. ClinicalTrials.gov. February 10, 2023. Updated February 10, 2023. Accessed February 16, 2023.