Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Simtuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01759511

GS-US-322-0206

Details and patient eligibility

About

The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Previous participation in Phase 1 Gilead clinical trial
• Diagnosis of idiopathic pulmonary fibrosis
• Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
• Females must discontinue nursing
• Comply with study requirements
• Have adequate organ function

Key Exclusion Criteria:

• History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
• Pregnant or lactating
• Clinically significant heart, hepatic or renal disease
• History of cancer within 5 years of screening
• Infection that is not controlled despite antibiotics or other treatment
• History of bleeding diathesis within the last 6 months of Day 1
• Known history of human immunodeficiency virus, hepatitis B or C
• Concern's for subjects compliance
• Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
• Placed on a lung transplant list
• Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

Simtuzumab

Experimental group

Description:

Participants will receive simtuzumab.

Treatment:

Drug: Simtuzumab