Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis, Hypoxemia

In brief

This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.

Key facts

Study ID

NCT02846324

Run by

Global Blood Therapeutics

People needed

39

Starts

2016-06-01

Expected to finish

2017-11-01

Last updated by the study team

2020-10-20

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of IPF.
• Oxygen desaturation with exercise.
• Completion of the baseline 6MWT
• Weight ≥ 50 kg
• Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.

You may not qualify if…

• FEV1/FVC < 70%.
• Subjects on supplemental oxygen therapy at rest.
• History of other interstitial lung diseases.
• Significant polycythemia.
• Female who is breast-feeding or pregnant.
• Known current malignancy or history of malignancy within the last 2 years prior to screening.
• Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
• Hospitalization due to an exacerbation of IPF within 30 days of screening
• Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
• Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
• Current smoker or history of smoking within 3 months of screening.
• Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
• History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
• Any condition possibly affecting drug absorption.
• Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
• Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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