Randomised, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF (ARTEMIS)

The ARTEMIS-IPF study is for people who have been diagnosed with IPF and are between 40 and 80 years of age. People who have been diagnosed early in the disease may be more responsive to treatment. This is a randomised study (which means the participants will be selected by chance (like flipping a coin) to receive one of two treatments (ambrisentan or placebo). This is a double-blind study which means participants and their study doctor won’t know what treatment they are assigned to receive. Participants will have 2 out of 3 chances to receive ambrisentan, or 1 out of 3 chances to receive placebo (which is a tablet that looks like the active medicine but contains no active medicine). Taking part in the study could be up to 3 years depending on how long it takes to enroll and observe study events. After randomisation, visits take place every 3 months. Laboratory visits occur every month.

Official Title

ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)

Conditions

• Idiopathic pulmonary fibrosis

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

• Time to death or disease (IPF) progression.
  [ Time Frame: Event driven, up to 3 years ]
  [ Designated as safety issue: No ]

Secondary outcome measures

• Proportion of subjects with disease progression or death at 48 weeks
  [ Time Frame: 1 year from enrollment ]
  [ Designated as safety issue: No ]

Study arms and assigned interventions

1. Ambrisentan: Active Comparator Subjects will be randomized in a 2:1 ratio to receive Ambrisentan Drug: ambrisentan or sugar pill
   • Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.
2. Placebo: Placebo Comparator Subjects will be randomized in a 2:1 ratio to receive active drug versus sugar pill (placebo)
   • Drug: ambrisentan or sugar pill  Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.  

Study Start

December 2008 – December 2012

Eligibility & Criteria

• Ages eligible for study: 40 years to 80 years
• Genders eligible for study: Both
• Accepts healthy volunteers: No

Inclusion criteria

• Diagnosis of IPF
• Honeycombing on HRCT scan of less than or equal to 5%
• Willing and able to have 2 right heart catheterisations performed
• Willing to have monthly lab tests
• Able to perform the 6 minute walk test
• Must meet lung function requirements
• Normal liver function tests

Exclusion criteria

• No restrictive lung disease (other than IPF)
• No obstructive lung disease
• No recent or active respiratory exacerbations
• No recent hospitalization for an IPF exacerbation
• No recent history of alcohol abuse
• Not pregnant, breast-feeding and willing to follow contraceptive measures per protocol if applicable
• Chronic sildenafil (or same drug class) use for pulmonary hypertension
• Chronic treatment with certain medications for IPF within 30 days of randomisation
• No other serious medical conditions

Total Enrolment

600

Contact Details

Crystal Green
AMS-IPF@gilead.com