|Age:||40 years or older|
|Keywords:||Idiopathic Pulmonary Fibrosis, IPF|
|Type:||Drug study, Phase 2|
If you qualify to take part in this research study, the study team will discuss the tests and procedures required in greater detail. Below is a brief overview.
Screening Phase (up to 5 weeks) If you decide to enroll in this study, the research team will need to determine whether you are eligible. To do this, you will be asked to undergo screening procedures. This Screening Phase can last up to 5 weeks, although it could be shorter and it includes Visit 1. If you qualify, you will proceed into the Treatment Phase of the study.
24-Week Treatment Phase: This is the phase of the study during which you will receive either the study drug CC-90001 or placebo. Placebo is a pill that looks like the study drug but contains no drug. The treatment you get will be chosen by chance, like flipping a coin at Visit 2 (this is called randomization).
You will have equal chance of receiving one of these 3 treatments: - CC-90001 200 mg once daily - CC-90001 400 mg once daily - or a placebo once daily
This means you will have a 2 in 3 chance of receiving the study drug. Neither you nor the study doctor will know which treatment you will be receiving. This phase will include Visits 2 (called a Baseline) through 9. Visit 3 will occur a week after visit 2, and all other visits will be 4 weeks apart.
28-Week Extension Treatment Phase: You will continue to take the study drug treatment (the same one you were taking in the 24-week Treatment Phase); however, your study doctor may give you an additional IPF medication to take if he/she thinks it is right for you. The choice of the additional IPF treatment and the time to start taking it will be left up to your study doctor. Because any additional IPF treatment is not considered study drug, it will be prescribed to you by your study doctor and you will know which drug you are receiving. This phase will include Visits 10 through 13 which are 6 weeks apart, and Visit 14 which is 4 weeks after Visit 13. If you discontinue study drug before Visit 14 you will undergo an End of Treatment Visit, which will include procedure identical to those on Visit 14.
4-Week Post-treatment Observational Follow-up Phase: After you complete the entire study or if you drop out early from the study, you will be expected to enter post-treatment follow-up phase. This phase will begin after you stop taking the study drug (after completing all 52 weeks of treatment or if you stop early) and will last 4 weeks. If you finish the entire study, you may have received study drug during the two treatment phases for a total time of 52 weeks (in this case this will be Visit 15 for you). If you leave the study early, you will be asked to complete an early termination visit and enter the 4-week Post-treatment Observational Followup phase.
Unscheduled Visits At any time during the study, if you feel you need to see the study doctor and it is not yet time for your next visit, call the study site and make an appointment. During this visit, the study doctor might do some tests if he/she thinks they are needed. The study doctor can also ask you to come in for some extra tests if he/she thinks it is in your best interest.
Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject understands and has voluntarily signed and dated an informed consent form 2. Subject is male or female ≥ 40 years of age 3. Subject was diagnosed with IPF within 4 years of Screening 4. Diagnosis of IPF is supported by HRCT and historical surgical lung biopsy (SLB) if available according to guidelines. 5. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed. 6. Percent predicted forced vital capacity (% FVC) ≥ 45% at Screening 7. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 85% predicted at Screening. 8. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening 9. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods. 10. Male subjects must practice true abstinence or use a barrier method of contraception. 11. Additional inclusion criteria apply.
The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subject with a QTc calculation using Fridericia's formula (QTcF) > 450 msec. 3. Evidence of clinically relevant airways obstruction at Screening. 4. Subjects using any therapy targeted to treat Idiopathic pulmonary fibrosis (IPF). 5. Use of ≥ 15 hours of supplemental oxygen per day or resting arterial oxygen saturation by pulse oximetry (SpO2) of < 92% (room air at sea level) or resting SpO2 of < 88% (room air at ≥ 5000 feet [1524 meters] above sea level). 6. Pregnancy or lactation. 7. Additional exclusion criteria apply.