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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Connecticut
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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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New Hampshire
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Wisconsin
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Namur
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Ontario
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Hessen
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Tel Aviv
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Jerusalem
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Israel
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Kfar Saba
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Petach Tikvah
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Italy
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Forli-cesena
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Monza E Brianza
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Catania
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Milano
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Modena
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Napoli
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Palermo
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Italy
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Roma
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Italy
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Siena
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Korea, Republic of
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Gyeonggi-do
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Gyeonggi-Do
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Seoul
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Lodzkie
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Pomorskie
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Slaskie
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Madrid
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Barcelona
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Sevilla
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Switzerland
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Sankt Gallen
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Switzerland
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Vaud
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Switzerland
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Basel
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United Kingdom
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England
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United Kingdom
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Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01769196
Trial related presentations / publications
Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01769196