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Summary

for people ages 40 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Details

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 24 weeks of treatment will continue onto the blinded 28-week Treatment Extension Phase. Following an initial screening at Visit 1, eligible subjects will be randomized to either CC-90001 200 mg or 400 mg PO QD or matching placebo beginning on Day 1 (Baseline Visit) of the study. Subjects completing the 24-week Double-blind Treatment Phase will continue the same blinded treatment assignment for 28 weeks in the Treatment Extension Phase. In the 28-week Treatment Extension Phase, all subjects will have the opportunity, if deemed appropriate by the Investigator, to use standard of care (SOC). The time to add and the choice of SOC will be at the Investigator's discretion. All subjects who complete the study treatment phases, or 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 internal DMC, comprised of four internal Celgene employees who are not associated with the CC-90001-IPF-001 study will be responsible for safeguarding study participants' interests and for monitoring the overall conduct of the study.

Keywords

Idiopathic Pulmonary Fibrosis Fibrosis Idiopathic Interstitial Pneumonias Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Idiopathic Pulmonary Fibrosis (IPF) Pulmonary Fibrosis CC-90001 Safety Efficacy IPF

Eligibility

You can join if…

Open to people ages 40 years and up

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) ≥ 30% 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.

You CAN'T join if...

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.

Locations

  • Stanford University Pulmonary and Critical Care Clinic not yet accepting patients
    Stanford, California, 94305, United States
  • Cedars Sinai Medical Center Rheumatology not yet accepting patients
    Los Angeles, California, 90048, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03142191
Phase
Phase 2
Study Type
Interventional
Last Updated
August 1, 2017
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