A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Status: | Recruiting |
---|---|
Conditions: | Pneumonia, Pulmonary, Pulmonary, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 4/6/2019 |
Start Date: | July 26, 2017 |
End Date: | February 22, 2022 |
Contact: | Associate Director Clinical Trial Disclosure |
Email: | clinicaltrialdisclosure@celgene.com |
Phone: | 1-888-260-1599 |
A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled
study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory
pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with
placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis
(IPF). This study is designed to assess response to treatment by using measures of lung
function, disease progression, fibrosis on radiography, and patient-reported outcomes. It
will also assess dose response.
study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory
pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with
placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis
(IPF). This study is designed to assess response to treatment by using measures of lung
function, disease progression, fibrosis on radiography, and patient-reported outcomes. It
will also assess dose response.
Approximately 135 adult male and female subjects with a confirmed diagnosis of Idiopathic
pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and
management) will be randomized 1:1:1 (45 subjects per arm) to treatment with oral CC-90001
(200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks.
Subjects completing the 24-week Double-blind Treatment Phase will continue onto the blinded
80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to
placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the
80-week Active Treatment Extension Phase, all subjects will have the opportunity, if deemed
appropriate by the Investigator, to receive standard of care (SOC). The time to add SOC and
the choice of SOC during the Extension Phase will be at the Investigator's discretion.
All subjects who complete the study treatment phases and those subjects who discontinue
investigational product (IP) prior to the completion of the study will participate in the
4-week Post-treatment Observational Follow-up Phase.
The study will be conducted in compliance with the International Council on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
An external DMC, comprised of independent physician experts and a statistician who are not
affiliated with the Sponsor and for whom there is no identified conflict of interest will be
responsible for safeguarding study participants' interests and for monitoring the overall
conduct of the study.
pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and
management) will be randomized 1:1:1 (45 subjects per arm) to treatment with oral CC-90001
(200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks.
Subjects completing the 24-week Double-blind Treatment Phase will continue onto the blinded
80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to
placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the
80-week Active Treatment Extension Phase, all subjects will have the opportunity, if deemed
appropriate by the Investigator, to receive standard of care (SOC). The time to add SOC and
the choice of SOC during the Extension Phase will be at the Investigator's discretion.
All subjects who complete the study treatment phases and those subjects who discontinue
investigational product (IP) prior to the completion of the study will participate in the
4-week Post-treatment Observational Follow-up Phase.
The study will be conducted in compliance with the International Council on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
An external DMC, comprised of independent physician experts and a statistician who are not
affiliated with the Sponsor and for whom there is no identified conflict of interest will be
responsible for safeguarding study participants' interests and for monitoring the overall
conduct of the study.
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 5 years of Screening
4. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy
[SLB] or cryobiopsy) 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% and ≤ 95% at Screening
7. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and
≤ 90% 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 QTcF > 450 msec.
3. Evidence of clinically relevant airways obstruction at Screening.
4. Subjects using any therapy targeted to treat IPF.
5. History of latent or active TB, unless there is medical record documentation of
successful completion of a standard course of treatment
6. History of hepatitis B and/or hepatitis C, including those considered successfully
treated/cured
7. Pregnancy or lactation.
8. Additional exclusion criteria apply.
We found this trial at
18
sites
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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University of Cincinnati Medical Center Opening in 1823 as the country
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Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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330 Trent Drive
Durham, North Carolina 27710
Durham, North Carolina 27710
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University of Louisville The University of Louisville is a state supported research university located in...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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