A Study of the Safety of Experimental CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis (decreased lung function)

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"The purpose of this study is to test an experimental drug called CC-90001 in patients with Idiopathic pulmonary fibrosis (IPF)."
Age: 40 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis, IPF
Type: Drug study, Phase 2
Target:
4 Participants
Investigator:
Description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease of unknown cause. IPF leads to the stiffening and scarring of the lung tissue, which prevents the lungs from working properly. This includes limiting their ability to take in oxygen. This in turn results in debilitating symptoms including shortness of breath and a decreased ability to exercise.

The purpose of this study is to test an experimental drug called CC-90001. “Experimental” means that the study drug is currently being tested. It is not approved for sale in the United States by the Food and Drug Administration (FDA). This study will test CC-90001 compared to placebo. A placebo is an inactive substance that contains no medicine. This study is being conducted to test the effect of CC-90001 on improving your IPF, and to see how well your body tolerates CC-90001.

CC-90001 works by interfering with JNK (c-Jun N-terminal kinase), a protein that the body produces in various situations. Scientists have seen evidence that JNK participates in inflammation and scarring in some body tissues. This includes the lungs of patients with IPF. Thus we hope that by reducing the action of JNK, CC-90001 may help treat IPF by decreasing inflammation and fibrosis in the lungs.

This study also includes testing of blood samples for biomarkers. Biomarkers are substances such as proteins in the blood that tell us how the drug is working in your body. The biomarker testing is mandatory. That means that you cannot participate in the study if you do not agree to participate in the biomarker testing. Further information on the biomarker testing can be found at the end of this document.
This study requires

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.

Who can participate

Inclusion criteria:

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.

Exclusion criteria:

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.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you up to $750.00 for your time and effort. You will be compensated $50.00 for each visit. You will be compensated at a rate of $0.53/mile for your mileage if you travel more than 20 miles one way to the study site.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for a maximum of 61 weeks, and will have to complete up to 15 visits to the study site.
Recruitment period
From Nov. 9, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Idiopathic Pulmonary Fibrosis
  • Fibrosis
  • Idiopathic Interstitial Pneumonias
  • Pathologic Processes
  • Lung Diseases, Interstitial
  • Lung Diseases
  • Respiratory Tract Diseases