Idiopathic Pulmonary FibrosisPhase 2NCT01203943
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing CC-930 in people with Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis, run by Celgene at 22 sites in 2 countries.
Trial summary
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis
- What is being tested?
- CC-930
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 1 Jan 2011to 24 Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
- Diagnosis of IPF based on current ATS/ERS guidelines
- Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
- Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
- UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP
Who cannot join
- FVC : < 50% predicted >90% predicted
- DLco:< 25% predicted >90% predicted
- Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
- Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
- Use of any cytokine modulators:
- Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
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- Alefacept within 24 months of randomization
- Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [eg bosentan, ambrisentan], interferon gamma-1B, pirfenidone) within 4 weeks of screening
- Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
- Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
- Current smoker
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States16 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati
Cincinnati, Ohio, 45267
Vermont Lung Center
Colchester, Vermont, 05446
Geisenger Center for Clinical Studies
Danville, Pennsylvania, 17822
Duke University Medical Center
Durham, North Carolina, 27705
University of Texas
Galveston, Texas, 77555
Baylor College of Medicine
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
University of Miami Miller School of Medicine
Miami, Florida, 33101
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai Medical Center
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
Stanford University, Pulmonary & Critical Care Clinic
Stanford, California, 94305
Canada6 sites
University of Calgary, Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
University of Alberta
Edmonton, Alberta, T6G 2C8
Victoria Hospital
London, Ontario, N6A 4G5
Notre-Dame Hospital du CHUM
Montreal, Quebec, H2L4M1
Vancouver General Hospital/University of British Columbia
Vancouver, British Columbia, V5Z 1M9
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
- Conditions
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial
- Being tested
- CC-930, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-930Drug
CC-930 50 mg PO daily up to 56 weeks beginning on Day 1
PlaceboOther
Placebo
CC-930Drug
CC-930 100 mg PO daily up to 56 weeks beginning on Day 1
CC-930Drug
C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | • Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM. Receives: Drug: CC-930 |
| Cohort 2 | Experimental | • Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM Receives: Drug: CC-930 |
| Cohort 3 | Experimental | • Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1. Receives: Drug: CC-930 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of participants with adverse events
Measured: Week 4
Secondary outcomes (10)
Long-term safety
Number of participants with adverse events
Measured: Weeks 52-104
Disease progression/death rates
Time to disease progression and death
Measured: Up to week 56
Disease progression/death rates
Time to disease progression and death from week 52
Measured: Weeks 52-104
Pharmacokinetics-Cmax
Maximum observed concentration in plasma
Measured: Week 1 (baseline) and week 2
Pharmacokinetics-Cmin
Minimum observed concentration in plasma
Measured: Week 0 (baseline) and week 2
Pharmacokinetics-AUC
Area under the plasma concentration - time curve
Measured: Week 0 (baseline) and week 2
Pharmacokinetics-Tmax
Time to reach Cmax
Measured: Week 0 (baseline) and week 2
Pharmacokinetics - t 1/2
Terminal half-life (t1/2)
Measured: Week 0 (baseline) and week 2
Pharmacokinetics-Vz/f
Apparent volume of distribution
Measured: Week 0 (baseline) and week 2
Pharmacokinetics-CL/F
Apparent total body clearance
Measured: Week 0 (baseline) and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study start1 Jan 2011
- Primary completion31 Jan 2012
- Study completion24 Aug 2012
Why it stopped: The benefit/ risk profile does not support continuation of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Smith, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203943
- Sponsor's protocol ID
- CC-930-IPF-001
- Status last verified
- Nov 2019
- First submitted
- 15 Sep 2010
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Velden JL, Ye Y, Nolin JD, Hoffman SM, Chapman DG, Lahue KG, Abdalla S, Chen P, Liu Y, Bennett B, Khalil N, Sutherland D, Smith W, Horan G, Assaf M, Horowitz Z, Chopra R, Stevens RM, Palmisano M, Janssen-Heininger YM, Schafer PH. JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers. Clin Transl Med. 2016 Dec;5(1):36. doi: 10.1186/s40169-016-0117-2. Epub 2016 Sep 2.
PubMed 27590145
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT01203943
- Acronym / sponsor ID
- CC-930-IPF-001
- Conditions
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial
- Keywords
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The benefit/ risk profile does not support continuation of this study.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Jan 2012 (actual)
- Study completion
- 24 Aug 2012 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CC-930• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM. |
| Cohort 2 | Experimental | Drug: CC-930• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM |
| Cohort 3 | Experimental | Drug: CC-930• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
- Diagnosis of IPF based on current ATS/ERS guidelines
Key exclusion criteria (11 listed)
- FVC : < 50% predicted >90% predicted
- DLco:< 25% predicted >90% predicted
- Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
- Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
- Use of any cytokine modulators:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-930CC-930 50 mg PO daily up to 56 weeks beginning on Day 1 | Drug | Cohort 1 |
| PlaceboPlacebo | Other | Placebo |
| CC-930CC-930 100 mg PO daily up to 56 weeks beginning on Day 1 | Drug | Cohort 2 |
| CC-930C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1 | Drug | Cohort 3 |
Primary outcome
Safety
Time frame: Week 4
Number of participants with adverse events
10 secondary outcomes
Long-term safety
Time frame: Weeks 52-104
Disease progression/death rates
Time frame: Up to week 56
Disease progression/death rates
Time frame: Weeks 52-104
Pharmacokinetics-Cmax
Time frame: Week 1 (baseline) and week 2
Pharmacokinetics-Cmin
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-AUC
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-Tmax
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics - t 1/2
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-Vz/f
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-CL/F
Time frame: Week 0 (baseline) and week 2
Results and safety
The study was stopped early (reason given: The benefit/ risk profile does not support continuation of this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 27590145van der Velden JL, Ye Y, Nolin JD, Hoffman SM, Chapman DG, Lahue KG, Abdalla S, Chen P, Liu Y, Bennett B, Khalil N, Sutherland D, Smith W, Horan G, Assaf M, Horowitz Z, Chopra R, Stevens RM, Palmisano M, Janssen-Heininger YM, Schafer PH. JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers. Clin Transl Med. 2016 Dec;5(1):36. doi: 10.1186/s40169-016-0117-2. Epub 2016 Sep 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Smith, MD study director
Celgene Corporation
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-930 in people with Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis, run by Celgene at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The benefit/ risk profile does not support continuation of this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.