EUCTR2016-003473-17-GB进行中（未招募）1 期
A Phase 2, 24-Week Randomized, Double-blind, Placebo-ControlledMulticenter Study, With an 80-Week Active Treatment Extension, toEvaluate the Efficacy and Safety of CC-90001 in Subjects with IdiopathicPulmonary Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is male or female = 40 years of age at the time of signing the
- •informed consent form (ICF)
- •2. Subject must understand and voluntarily sign an ICF prior to any
- •study-related assessments/procedures being conducted
- •3. Subject is willing and able to adhere to the study visit schedule and
- •other protocol requirements
- •4. Investigator has considered all available IPF treatment options with
- •the potential subject before consenting the subject for participation in
- •5. Diagnosis of IPF is supported by HRCT as described in the Protocol
- •6. Extent of fibrotic changes (eg, honeycombing, reticular changes)
- •greater than the extent of emphysema on HRCT scan, as determined by
- •central review
- •7. No features supporting an alternative diagnosis on transbronchial
- •biopsy, bronchoalveolar lavage (BAL), or SLB, if performed
- •8. Percent predicted forced vital capacity ( FVC) = 45% at Screening
- •confirmed by central review
- •9. Change in FVC (measured in milliliters [mL]) between Screening and
- •Day 1 less than a 10% relative difference, calculated as: the absolute
- •value of 100% * (Screening FVC [mL] - Day 1 FVC [mL]) / Screening FVC
- •10.Hemoglobin-corrected percent predicted diffusion capacity of the lung
- •for carbon monoxide (DLCO) = 25% and = 85% predicted at Screening
- •11. Able to walk = 150 meters during the 6-minute walk test (6MWT) at
- •12. Investigator has considered all available IPF treatment options with
- •the potential subject before consenting the subject for participation in
- •Females of childbearing potential (FCBP) 1 must:
- •a. Have two negative pregnancy tests as verified by the Investigator
- •prior to starting IP. She must agree to ongoing pregnancy testing during
- •the course of the study, and after end of study treatment. This applies
- •even if the subject practices true abstinence from heterosexual contact.
- •[refer to protocol]
- •b. Either commit to true abstinence* from heterosexual contact (which
- •must be reviewed on a monthly basis and source documented) or agree
- •to use two effective birth control methods (one of which is highly
- •effective) at the same time, and be able to comply with, effective
- •contraception without interruption, 28 days prior to starting IP, during
- •the study therapy (including dose interruptions), and for 28 days after
- •discontinuation of IP [Refer to protocol]
- •13. Male subjects must:
- •Practice true abstinence (which must be reviewed on a monthly basis) or
- •agree to use a latex condom or nonlatex condom not made out of natural
- •(animal) membrane (eg, polyurethane) during sexual contact with a
- •pregnant female or a female of childbearing potential while participating
- •in the study, during dose interruptions and for at least 28 days following
- •IP discontinuation, even if he has undergone a successful vasectomy.
- •14. For subjects stratified to the protocol-allowable standard of care
- •therapy group (only): Subjects must be receiving and agree to maintain
- •the same dose of protocol-allowable standard of care (SOC) therapy for
- •at least 8 weeks prior to Screening Visit 1 and must agree to continue
- •this dose through Visit 9/Week 24. Adjustments in pirfenidone dose
- •after randomization (Visit 2) may be allowed for safety or tolerability
- 另有 8 项未显示
排除标准
- •1. Subject has any significant medical condition, laboratory abnormality,
- •or psychiatric illness that would prevent the subject from participating in
- •2. Subject has any condition including the presence of laboratory
- •abnormalities, which places the subject at unacceptable risk if he/she
- •were to participate in the study
- •3. Subject has any condition that confounds the ability to interpret data
- •from the study
- •4. Significant clinical worsening of IPF between Screening and Baseline
- •(Visit 2), in the opinion of the Investigator
- •5. Subjects with any of the following laboratory criteria:
- •White blood cell count (WBC) < 3500/mm3 (< 3.5 X 109/L) or >
- •14,000/mm3 (> 14 X 109/L)
- •Platelet count < 120,000/µL (< 120 X 109/L)
- •Serum creatinine > 1.5 mg/dL (> 132.6 µmol/L)
- •Aspartate aminotransferase (AST/SGOT) > 1.5 X upper limit of normal
- •Alanine aminotransferase (ALT/SGPT) > 1.5 X upper limit of normal (ULN)
- •Total bilirubin > 2 mg/dL (> 34.2 µmol/L)
- •Hemoglobin < 10 g/dL (< 100 g/L)
- •6. Subject with a QTcF > 450 msec
- •7. Any condition other than IPF that in the opinion of the Investigator is
- •likely to result in the death of the subject within the next year
- •8. Inability to obtain reproducible, high-quality pulmonary function tests.
- •9. Evidence of clinically relevant airways obstruction (ie, FEV1/FVC <
- •0.7) at Screening and/or significant respiratory disorder/pathology (eg,
- •pulmonary arterial hypertension requiring treatment, asthma,
- •tuberculosis, sarcoidosis, hypersensitivity pneumonitis, aspergillosis,
- •asbestosis, neoplastic disease, cystic fibrosis or other interstitial lung
- •disease) other than IPF
- •10. Subject is likely to have lung transplantation during the first 24
- •weeks of the study (being on transplantation list is acceptable for
- •participation)
- •11. Impairment (other than dyspnea) limiting the ability to comply with
- •study requirements (eg, pulmonary function tests, 6-minute walk test)
- •12. Subjects using the following medications: nintedanib, endothelium
- •receptor antagonists (eg, bosentan, ambrisentan), interferon gamma-1b,
- •imatinib mesylate, N-acetylcysteine, azathioprine, cyclophosphamide,
- •methotrexate, mycophenolate mofetil, cyclosporine, and oral steroids
- •(eg, prednisone > 12.5 mg/day or equivalent) within 4 weeks prior to
- •the Screening Visit. (Note: Refer to protocol.)
- •13. Use of any cytokine modulator/biologic, such as etanercept,
- •adalimumab, efalizumab, infliximab, or rituximab within 12 weeks of
- •randomization
- •14. Use of an inhaled long-acting bronchodilator within 24 hours of the
- •Screening Visit or short-acting bronchodilator within 8 hours of the
- •Screening Visit
- •15. Use of drugs that are known to cause hepatotoxicity, such as, but not
- •limited to, acetaminophen (paracetamol) at dosages of > 3 grams/day
- •and niacin dosage of > 2 grams/day while on study or within 2 weeks of
- •first dose of IP
- •16. Use of any medications that are substrates of one or more of the
- 另有 11 项未显示
研究者
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