Plaque PsoriasisPhase 4NCT02274792
Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis
A Phase 4 study testing Etanercept in people with Plaque Psoriasis, run by Amgen at 45 sites in 2 countries.
Trial summary
The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Jan 2015to Nov 2015
- Phase
- Phase 4
- 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 18 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age at time of screening.
- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
- Subject has involved body surface area (BSA) ≥ 10%, static physician global assessment (sPGA) ≥ 3, and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
- Subject is naïve to etanercept.
- Subject is a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept, as applicable.
- Subject is able to self-inject etanercept or have a designee who can do so.
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- Subject has not used methotrexate within 4-weeks from the first dose of etanercept.
- Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody.
- Subject has no known history of active tuberculosis.
- Subject has a negative test for tuberculosis during screening
- Subject, if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative serum pregnancy test ≤ 4 weeks from starting etanercept and a negative urine pregnancy test at baseline (day 1).
Who cannot join
- Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- Subject has any uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).
- Myocardial infarction or unstable angina pectoris within the last year.
- Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis.
- Multiple sclerosis or any other demyelinating disease.
- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of etanercept. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
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- Known history of alcoholic hepatitis or immunodeficiency syndromes including human Immunodeficiency virus (HIV) infection.
- Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept.
- Subject has a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to first dose of etanercept.
- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
- Subject has any condition that could, in the opinion of the investigator, compromise the subject's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States33 sites
Research Site
Andover, Massachusetts, 01810
Research Site
Aventura, Florida, 33180
Research Site
Bakersfield, California, 93309
Research Site
Bellaire, Texas, 77401
Research Site
Beverly Hills, California, 90212
Research Site
Carmel, Indiana, 46032
Research Site
Cincinnati, Ohio, 45249
Research Site
Clarkston, Michigan, 48346
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75231
Research Site
Denver, Colorado, 80210
Research Site
Denver, Colorado, 80220
Research Site
Fremont, California, 94538
Research Site
Indianapolis, Indiana, 46256
Research Site
Johnston, Rhode Island, 02919
Research Site
Los Angeles, California, 90036
Research Site
Louisville, Kentucky, 40202
Research Site
Miami, Florida, 33144
Research Site
Mobile, Alabama, 36608
Research Site
Nashville, Tennessee, 37205
Research Site
New Albany, Indiana, 47150
Research Site
Norfolk, Virginia, 23507
Research Site
Omaha, Nebraska, 68144
Research Site
Overland Park, Kansas, 66202
Research Site
Overland Park, Kansas, 66215
Research Site
Owensboro, Kentucky, 42303
Research Site
Pembroke Pines, Florida, 33028
Research Site
Raleigh, North Carolina, 27612
Research Site
Rockville, Maryland, 20850
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78249
Research Site
Verona, New Jersey, 07044
Research Site
Worcester, Massachusetts, 01605
Canada12 sites
Research Site
Barrie, Ontario, L4M 7G1
Research Site
Bathurst, New Brunswick, E2A 4Z9
Research Site
Courtice, Ontario, L1E 3C3
Research Site
Greater Sudbury, Ontario, P3C 1X8
Research Site
Kingston, Ontario, K7L 1S2
Research Site
Markham, Ontario, L3P 1X2
Research Site
Oakville, Ontario, L6J 7W5
Research Site
St. John's, Newfoundland and Labrador, A1A 4Y3
Research Site
Surrey, British Columbia, V3R 6A7
Research Site
Toronto, Ontario, M5S 3B4
Research Site
Toronto, Ontario, M8X 1Y9
Research Site
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis
The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.
Read the detailed description
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Etanercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel®
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).
Measured: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
Secondary outcomes (4)
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
Measured: Week 24
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
Measured: Week 12
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Measured: Week 24
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274792
- Sponsor's protocol ID
- 20101177
- Status last verified
- Oct 2016
- First submitted
- 22 Oct 2014
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02274792
- Acronym / sponsor ID
- 20101177
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 29 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.
Detailed description
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptParticipants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is ≥ 18 years of age at time of screening.
- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
- Subject has involved body surface area (BSA) ≥ 10%, static physician global assessment (sPGA) ≥ 3, and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
- Subject is naïve to etanercept.
- Subject is a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept, as applicable.
Key exclusion criteria (11 listed)
- Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- Subject has any uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).
- Myocardial infarction or unstable angina pectoris within the last year.
- Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis.
- Multiple sclerosis or any other demyelinating disease.
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 |
|---|---|---|
| EtanerceptAlso: Enbrel®Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection. | Drug | Etanercept |
Primary outcome
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
Time frame: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).
4 secondary outcomes
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
Time frame: Week 24
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
Time frame: Week 12
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
Time frame: Week 24
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Plaque Psoriasis, run by Amgen at 45 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 11 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: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 29 Dec 2016). 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?
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study (time frame: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.). 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 29 Dec 2016.