A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Launched by GILEAD SCIENCES · May 27, 2011
Trial Information
Current as of June 07, 2025
Completed
Keywords
ClinConnect Summary
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011.
In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Acceptable results on pulmonary function tests
- • 2. At rest oxygen saturation ≥90% on room air
- • 3. Adequate organ function
- Exclusion Criteria:
- • 1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis
- • 2. Acceptable results on whole body plethysmography
- • 3. History of clinically significant hepatic or renal disease
- • 4. Poorly controlled or severe diabetes mellitus
- • 5. Use of systemic immunosuppressants within 28 days of GS-6624 infusion
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Stanford, California, United States
Nashville, Tennessee, United States
Los Angeles, California, United States
Scottsdale, Arizona, United States
Council Bluffs, Iowa, United States
Pittsburg, Pennsylvania, United States
Patients applied
Trial Officials
Zung Thai, MD
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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