Idiopathic Pulmonary FibrosisPhase 2NCT02846324
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
A Phase 2 study testing GBT440 in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Global Blood Therapeutics at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- What is being tested?
- GBT440
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2016to Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Birmingham, Alabama, 35233
Study site
Charleston, South Carolina, 29425
Study site
Denver, Colorado, 80206
Study site
Falls Church, Virginia, 22042
Study site
Kansas City, Kansas, 66160
Study site
Miami, Florida, 33136
Study site
Nashville, Tennessee, 37212
Study site
New Orleans, Louisiana, 70122
Study site
New York, New York, 10032
Study site
Philadelphia, Pennsylvania, 19145
Study site
Salt Lake City, Utah, 84108
Study site
San Francisco, California, 94143
About this study
Official title: A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Being tested
- GBT440, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT440Drug
Capsules which contain GBT440 drug substance in Swedish orange
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| GBT440 600 mg Dose | Experimental | Parts A and B Receives: Drug: GBT440 |
| GBT440 900 mg Dose | Experimental | Part A Receives: Drug: GBT440 |
| GBT440 1500 mg Dose | Experimental | Part B Receives: Drug: GBT440 |
| Placebo | Placebo comparator | Parts A and B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Measured: Days 1 to 58
Secondary outcomes (5)
Pharmacokinetic Profile of GBT440 Including Maximum Concentration
Measured: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Pharmacokinetic Profile of GBT440 Including Minimum Concentration
Measured: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life
Measured: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest
Data reported is change from baseline in Oxygen Saturation at rest
Measured: Baseline to Day 28
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise
Change from Baseline to Day 28 after 6MWT
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Blood Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846324
- Sponsor's protocol ID
- GBT440-006
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2016
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02846324
- Acronym / sponsor ID
- GBT440-006
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Global Blood TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Posted 22 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GBT440 600 mg Dose | Experimental | Drug: GBT440Parts A and B |
| GBT440 900 mg Dose | Experimental | Drug: GBT440Part A |
| GBT440 1500 mg Dose | Experimental | Drug: GBT440Part B |
| Placebo | Placebo comparator | Drug: PlaceboParts A and B |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBT440Capsules which contain GBT440 drug substance in Swedish orange | Drug | GBT440 1500 mg Dose, GBT440 600 mg Dose, GBT440 900 mg Dose |
| PlaceboPlacebo capsules | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Time frame: Days 1 to 58
5 secondary outcomes
Pharmacokinetic Profile of GBT440 Including Maximum Concentration
Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Pharmacokinetic Profile of GBT440 Including Minimum Concentration
Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life
Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest
Time frame: Baseline to Day 28
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBT440 in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Global Blood Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 (time frame: Days 1 to 58). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.