Pulmonary SarcoidosisPhase 2NCT01732211
A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
A Phase 2 study testing PD 0360324 and Normal Saline for injection in people with Pulmonary Sarcoidosis, run by Pfizer at 5 sites in United States.
Trial summary
The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- PD 0360324 and Normal Saline for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Mar 2013to 23 Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for at least 1 year;
- Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal values at screening;
- age 21-75 years of age;
- treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to Screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol)
Who cannot join
- History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring maintenance treatment, chronic obstructive pulmonary disease (COPD));
- Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB, HIV);
- treatment with other biologic anti-inflammatory/immuno-modulatory drugs;
- active smokers;
- class 3 or 4 congestive heart failure;
- cancer, or history of cancer within past 5 years;
Show all 9Show fewer
- history of ischemic heart disease, heart attack, stroke, any heart muscle disease;
- liver disease;
- history of alcohol or drug abuse
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Medical Arts Building
Cincinnati, Ohio, 45219
The Barrett Cancer Center at UC Health
Cincinnati, Ohio, 45219
University Hospital
Cincinnati, Ohio, 45219
Iinterstitial Lung Disease & Sarcoidosis Clinic
Cincinnati, Ohio, 45267
Mount Sinai School Of Medicine/Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS
The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.
Read the detailed description
The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- PD 0360324, Normal Saline for injection
- Keywords
- Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel, 20 Week Safety, Tolerability, and Efficacy Study
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0360324Biological
100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;
Normal Saline for injectionOther
normal saline Q2W via intravenous infusion for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PD 0360324 | Experimental | Not described Receives: Biological: PD 0360324 |
| Placebo | Placebo comparator | Not described Receives: Other: Normal Saline for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline, Week 16
Secondary outcomes (7)
Change From Baseline in Chest X-ray Global Assessment Score (5-point )
Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.
Measured: Baseline, Week 16
Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Measured: Baseline, Weeks 2, 4, 8, 12, 14, and 20
Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20
The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline, Weeks 2, 4, 8, 12, 14, and 20
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Measured: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20
The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Measured: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Measured: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.
Measured: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study start15 Mar 2013
- Primary completion23 Sep 2013
- Study completion23 Sep 2013
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732211
- Sponsor's protocol ID
- A6261009
- Status last verified
- Dec 2019
- First submitted
- 19 Nov 2012
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS
- ClinicalTrials.gov ID
- NCT01732211
- Acronym / sponsor ID
- A6261009
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel, 20 Week Safety, Tolerability, and Efficacy Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2013 (actual)
- Primary completion
- 23 Sep 2013 (actual)
- Study completion
- 23 Sep 2013 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.
Detailed description
The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD 0360324 | Experimental | Biological: PD 0360324 |
| Placebo | Placebo comparator | Other: Normal Saline for injection |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for at least 1 year;
- Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal values at screening;
- age 21-75 years of age;
- treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to Screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol)
Key exclusion criteria (9 listed)
- History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring maintenance treatment, chronic obstructive pulmonary disease (COPD));
- Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB, HIV);
- treatment with other biologic anti-inflammatory/immuno-modulatory drugs;
- active smokers;
- class 3 or 4 congestive heart failure;
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 |
|---|---|---|
| PD 0360324100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy; | Biological | PD 0360324 |
| Normal Saline for injectionnormal saline Q2W via intravenous infusion for 12 weeks | Other | Placebo |
Primary outcome
Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
Time frame: Baseline, Week 16
The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
7 secondary outcomes
Change From Baseline in Chest X-ray Global Assessment Score (5-point )
Time frame: Baseline, Week 16
Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks
Time frame: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD 0360324 and Normal Saline for injection in people with Pulmonary Sarcoidosis, run by Pfizer at 5 sites in United States.
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 4 inclusion and 9 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2020.