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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01769196




Registration number
NCT01769196
Ethics application status
Date submitted
14/01/2013
Date registered
16/01/2013
Date last updated
30/05/2017

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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)
Secondary ID [1] 0 0
2012-001571-36
Secondary ID [2] 0 0
GS-US-322-0207
Universal Trial Number (UTN)
Trial acronym
RAINIER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Simtuzumab
Treatment: Drugs - Simtuzumab placebo

Experimental: Simtuzumab - Participants will receive simtuzumab for up to 254 weeks.

Placebo comparator: Simtuzumab Placebo - Participants will receive simtuzumab placebo for up to 254 weeks.


Treatment: Drugs: Simtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week

Treatment: Drugs: Simtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Up to 148 weeks
Primary outcome [2] 0 0
PFS Among the Participants With sLOXL2 = 50th Percentile
Timepoint [2] 0 0
Up to 148 weeks
Primary outcome [3] 0 0
PFS Among the Participants With sLOXL2 = 75th Percentile
Timepoint [3] 0 0
Up to 148 weeks
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 151 weeks
Secondary outcome [2] 0 0
Overall Survival Among the Participants With sLOXL2 = 50th Percentile
Timepoint [2] 0 0
Up to 151 weeks
Secondary outcome [3] 0 0
Overall Survival Among the Participants With sLOXL2 = 75th Percentile
Timepoint [3] 0 0
Up to 151 weeks
Secondary outcome [4] 0 0
Relative Change From Baseline in FVC % Predicted
Timepoint [4] 0 0
Weeks 54, 106, and 130
Secondary outcome [5] 0 0
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Timepoint [5] 0 0
Up to 148 weeks
Secondary outcome [6] 0 0
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Timepoint [6] 0 0
Up to 148 weeks
Secondary outcome [7] 0 0
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Timepoint [7] 0 0
Up to 148 weeks
Secondary outcome [8] 0 0
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Timepoint [8] 0 0
Weeks 58, 106, and 130
Secondary outcome [9] 0 0
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
Timepoint [9] 0 0
Week 58, 106, and 130

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2016
Sample size
Target
Accrual to date
Final
544
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Saint Vincents Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [5] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Iowa
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Hessen
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Kfar Saba
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Petach Tikvah
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Forli-cesena
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Monza E Brianza
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Catania
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Roma
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Siena
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England
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT01769196