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Recruiting

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis - CC-90001-IPF-001

Actualizada: 31 marzo, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2

    Fase

  • Géneros

  • 40+

    Rango de edad

  • 40

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: CC-90001 200 mg PO QD
Drug: CC-90001
Experimental: CC-90001 400 mg PO QD
Drug: CC-90001
Experimental: CC-90001 400 mg PO QD- Sub-Study
Drug: CC-90001
Placebo Comparator: Placebo PO QD
Other: Placebo
Placebo Comparator: Placebo PO QD- Sub-Study
Other: Placebo

Criterios clave de elegibilidad

Inclusion Criteria: Subject understands and has voluntarily signed and dated an informed consent form 1. Subject is male or female ≥ 40 years of age 2. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines. 3. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed. 4. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening 5. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening. 6. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening 7. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods. 8. Male subjects must practice true abstinence or use a barrier method of contraception. 9. 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 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.

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Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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