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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01769196
• Date of registration: 14/01/2013
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) RAINIER
• Scientific title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
• Date of first enrolment: January 31, 2013
• Target sample size: 544
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01769196
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Poland, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & 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.



Age minimum: 45 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Simtuzumab

Drug: Simtuzumab placebo

Primary Outcome(s)

PFS Among the Participants With sLOXL2 = 50th Percentile [Time Frame: Up to 148 weeks]

PFS Among the Participants With sLOXL2 = 75th Percentile [Time Frame: Up to 148 weeks]

Progression Free Survival [Time Frame: Up to 148 weeks]

Secondary Outcome(s)

Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score [Time Frame: Week 58, 106, and 130]

Absolute Change From Baseline in 6 Minute Walk Distance (6MWD) [Time Frame: Weeks 58, 106, and 130]

Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations [Time Frame: Up to 148 weeks]

Overall Survival (OS) [Time Frame: Up to 151 weeks]

Overall Survival Among the Participants With sLOXL2 = 50th Percentile [Time Frame: Up to 151 weeks]

Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death [Time Frame: Up to 148 weeks]

Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations [Time Frame: Up to 148 weeks]

Overall Survival Among the Participants With sLOXL2 = 75th Percentile [Time Frame: Up to 151 weeks]

Relative Change From Baseline in FVC % Predicted [Time Frame: Weeks 54, 106, and 130]

Secondary ID(s)

2012-001571-36

GS-US-322-0207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01769196