Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Simtuzumab placebo; Drug: Simtuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01769196

2012-001571-36 (EudraCT Number)

GS-US-322-0207

Details and patient eligibility

About

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

Enrollment: 544 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female subjects from 45 to 85 years of age
• Definite IPF within 3 years prior to screening
• Be able to walk at least 50 meters

Key Exclusion Criteria:

• Significant diseases other than IPF

• Obstructive lung disease

• Aortic aneurysm greater than or equal to 3.5 cm in diameter

• Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.

  • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
  • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located

• Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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544 participants in 2 patient groups, including a placebo group

Simtuzumab

Experimental group

Description:

Participants will receive simtuzumab for up to 254 weeks.

Treatment:

Drug: Simtuzumab

Simtuzumab Placebo

Placebo Comparator group

Description:

Participants will receive simtuzumab placebo for up to 254 weeks.

Treatment:

Drug: Simtuzumab placebo