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

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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.

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.

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.
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234 Goodman Dr
Cincinnati, Ohio 45229
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3500 Gaston Avenue
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Camperdown, New South Wales 2050
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Chesterfield, Missouri 63017
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Los Angeles, California 90048
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Louisville, Kentucky
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200 Lothrop St
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Salt Lake City, Utah 84132
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