Randomized Phase IIa Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
G Raghu, M Mouded, A Prasse, C Stebbins… - American journal of …, 2022 - atsjournals.org
G Raghu, M Mouded, A Prasse, C Stebbins, G Zhao, G Song, M Arefayene, SM Violette…
American journal of respiratory and critical care medicine, 2022•atsjournals.orgMethods This randomized, double-blind, placebo-controlled, dose-escalation study
(NCT01371305) was conducted from July 16, 2012, through March 31, 2017, at 17 sites in
the United States. Patients with IPF with a predicted FVC⩾ 50% were randomized 3: 1 to
receive subcutaneous BG00011 (n= 31) or placebo (n= 10) once weekly for 8 weeks.
Patients were enrolled into 5 dose cohorts (0.015–3.0 mg/kg, n= 8 each) and followed for an
additional 12 weeks. The study was approved by all relevant institutional review boards …
(NCT01371305) was conducted from July 16, 2012, through March 31, 2017, at 17 sites in
the United States. Patients with IPF with a predicted FVC⩾ 50% were randomized 3: 1 to
receive subcutaneous BG00011 (n= 31) or placebo (n= 10) once weekly for 8 weeks.
Patients were enrolled into 5 dose cohorts (0.015–3.0 mg/kg, n= 8 each) and followed for an
additional 12 weeks. The study was approved by all relevant institutional review boards …
Methods
This randomized, double-blind, placebo-controlled, dose-escalation study (NCT01371305) was conducted from July 16, 2012, through March 31, 2017, at 17 sites in the United States. Patients with IPF with a predicted FVC⩾ 50% were randomized 3: 1 to receive subcutaneous BG00011 (n= 31) or placebo (n= 10) once weekly for 8 weeks. Patients were enrolled into 5 dose cohorts (0.015–3.0 mg/kg, n= 8 each) and followed for an additional 12 weeks. The study was approved by all relevant institutional review boards. Informed consent was obtained from all participants.
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