PsoriasisPhase 1NCT00867100
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
A Phase 1 study testing 700 mg IV, 350 mg SC and 140 mg SC in people with Psoriasis, run by Bausch Health Americas, Inc..
Trial summary
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 700 mg IV, 350 mg SC and 140 mg SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Sep 2009
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A:
- Able to provide written informed consent
- Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
- Additional inclusion criteria apply
- Part B:
- 18 - 55 years old inclusive at Screening
Show all 10Show fewer
- Active but clinically stable, plaque psoriasis
- Psoriasis involving ≥ 10% of the body surface area
- A minimum PASI score of ≥ 10 obtained during the screening period
- Additional inclusion criteria apply
Who cannot join
- Part A:
- History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
- Additional exclusion criteria apply
- Part B:
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
Show all 9Show fewer
- Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
- Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
- Additional exclusion criteria apply
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
Read the detailed description
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
- Conditions
- Psoriasis
- Being tested
- 700 mg IV, 350 mg SC, Placebo, 140 mg SC
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
700 mg IVDrug
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
350 mg SCDrug
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
PlaceboDrug
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
140 mg SCDrug
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
| 140 mg SC | Experimental | 140 mg SC PsO Receives: Drug: 140 mg SC |
| 350 mg SC | Active comparator | 350 mg SC PsO Receives: Drug: 350 mg SC |
| 700 mg IV | Experimental | 700 mg IV PsO Receives: Drug: 700 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.
Measured: Through day 43
Part B: All Treatment Adverse Events Reported for Safety Evaluation
This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Measured: 85 days
Part A: All Treatment Adverse Events Reported for Safety Evaluation
This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.
Measured: Cohort 1-4 43 days, Cohort 5-8 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionSep 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867100
- Sponsor's protocol ID
- 20060279
- Status last verified
- Jul 2018
- First submitted
- 20 Mar 2009
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.
PubMed 22622425
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00867100
- Acronym / sponsor ID
- 20060279
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
Detailed description
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment |
| 140 mg SC | Experimental | Drug: 140 mg SC140 mg SC PsO |
| 350 mg SC | Active comparator | Drug: 350 mg SC350 mg SC PsO |
| 700 mg IV | Experimental | Drug: 700 mg IV700 mg IV PsO |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Able to provide written informed consent
- Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
- Additional inclusion criteria apply
- 18 - 55 years old inclusive at Screening
- Active but clinically stable, plaque psoriasis
Key exclusion criteria (9 listed)
- History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
- Additional exclusion criteria apply
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
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 |
|---|---|---|
| 700 mg IVsingle SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). | Drug | 700 mg IV |
| 350 mg SCsingle SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). | Drug | 350 mg SC |
| Placebosingle SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). | Drug | Placebo |
| 140 mg SCsingle SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). | Drug | 140 mg SC |
Primary outcome
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
Time frame: Through day 43
Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.
Part B: All Treatment Adverse Events Reported for Safety Evaluation
Time frame: 85 days
This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Part A: All Treatment Adverse Events Reported for Safety Evaluation
Time frame: Cohort 1-4 43 days, Cohort 5-8 64 days
This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22622425Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 700 mg IV, 350 mg SC and 140 mg SC in people with Psoriasis, run by Bausch Health Americas, Inc..
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 10 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 16 Jan 2019). 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?
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (time frame: Through day 43). The study lists 3 primary outcomes in all. 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 NCT00867100, 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 16 Jan 2019.