Cutaneous LupusPhase 1NCT01389895
Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
A Phase 1 study testing AMG 557 in people with Cutaneous Lupus and Lupus, run by Amgen at 10 sites in 3 countries.
Trial summary
This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous Lupus, Lupus
- What is being tested?
- AMG 557
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
- Body mass index from 18 to 35 kg/m2 at screening;
- Diagnosis of subacute cutaneous lupus erythematosus (SCLE) with or without systemic lupus erythematosus (SLE). SCLE as defined by the Gilliam and Sontheimer classification (J Am Acad Dermatol 1981; 4(4):471-475). SLE is defined by the most recent American College of Rheumatology criteria, including positive antinuclear antibodies (ANA) during screening or by documented history (at least 1:80 by indirect immunofluorescent assay);
- A history of skin biopsy consistent with the diagnosis of SCLE;
- Positive SS-A and/or SS-B antibodies at screening;
- Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity as defined by: at least 2 areas with at least level 2 erythema or 3 areas with at least level 1 erythema using cutaneous lupus erythematosus disease area and severity index (CLASI). The total CLASI activity must be ≥ 10;
Show all 10Show fewer
- Subject must have stable disease activity for 3 months prior to screening in the clinical judgment of the Principal Investigator (PI) with no anticipated changes in therapy;
- Stable dose of topical steroids no stronger than medium-potency (Class III or Class VII) for ≥ 2 weeks from screening is permitted;
- Prednisone ≤ 10 mg/day (or equivalent) is permitted;
- Stable doses of methotrexate ≤ 20 mg/week, azathioprine ≤ 150 mg/day, and 6-mercaptopurine ≤ 150 mg/day for 12 weeks prior to screening are permitted.
Who cannot join
- Drug-induced SCLE;
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SCLE, SLE, or Sjögren's syndrome) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion. This includes any age related co-morbidities such as presence of congestive heart failure, angina, chronic obstructive pulmonary disease, and asthma;
- Presence or history of vasculitis (comprising internal organs or extremities or leading to peripheral neuropathy) within the last 3 years, presence or history of active Central Nervous System (CNS) lupus (defined as seizure disorder, cerebral vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis) requiring therapy within the last 3 years;
- History of malignancy;
- Signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization, or recent history of repeated infections;
- Underlying condition other than SCLE, SLE, Sjögren's syndrome that predisposes one to infections (eg, history of splenectomy);
Show all 11Show fewer
- Administration of >10 mg/day prednisone (or equivalent) in the 30 days prior to randomization;
- Prior use of any following biological agents: Rituximab, Lymphostat-B, TACl-Ig, and CTLA4-Ig;
- Current treatment (within 3 months or 5 half-lives of screening) with thalidomide, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, Intravenous (IV) immunoglobulin, plasmapheresis, oral or IV cyclophosphamide;
- Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of study medication).
- 29. Use of any other over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer), prior to receiving the first dose of study medication. Acetaminophen (up to 2 g per day) for analgesia and hormone replacement therapy (eg, estrogen, thyroid) will be allowed. In addition, prescription drugs for hypertension or hypercholesterolemia, oral hypoglycemic drugs, or NSAIDs will be allowed; however, NSAIDS are not permitted within 24 hours of skin biopsies to reduce the risk of bleeding. Other medications may be approved following review by the Principal Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen acknowledgement is required for subject participation;
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
Research Site
Ann Arbor, Michigan, 48103
Research Site
Austin, Texas, 78705
Research Site
Birmingham, Alabama, 35233
Research Site
Dallas, Texas, 75231
Study site
Dallas, Texas, 75231
Research Site
Dallas, Texas, 75235
Research Site
Philadelphia, Pennsylvania, 19104
Australia2 sites
Research Site
Carlton, Victoria, 3053
Research Site
Woolloongabba, Queensland, 4102
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.
Read the detailed description
Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed. After Cohort 1 and 2 enrollment has been completed, the emerging PK and PD data will be reviewed to determine if an additional 4-8 subjects with SCLE will be enrolled into the study to address equivocal results from the study. These 4-8 additional subjects will receive the same dose of either 210 mg or 140 mg SC (in an allocation ratio of 1 AMG 557: 1 placebo).
In addition, an open label extension study for participants in this study may be instituted following completion and analysis of results of this study. Initiation of this study will require that an acceptable risk-benefit profile and some evidence of efficacy are observed in the current study.
- Conditions
- Cutaneous Lupus, Lupus
- Being tested
- AMG 557, AMG 557 Placebo
- Keywords
- Lupus, Cutaneous lupus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 557Drug
AMG 557 (210 mg) or (140 mg ) will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive AMG 557. Beginning on Day 1, subjects will receive either 210 mg AMG 557 or 140 mg AMG 557 once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of AMG 557 every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.
AMG 557 PlaceboDrug
AMG 557 Placebo (210 mg) or (140 mg )will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive placebo. Beginning on Day 1, subjects will receive placebo once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of placebo every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.
| Study group | Role | What they receive |
|---|---|---|
| AMG 557 | Active comparator | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Receives: Drug: AMG 557 |
| AMG 557 Placebo | Placebo comparator | All will receive placebo on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Receives: Drug: AMG 557 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557
Measured: 253 Days
Secondary outcomes (3)
Determine the pharmacokinetic (PK) profile of AMG 557 after multiple subcutaneous (SC) doses in subacute cutaneous lupus erythematosus (SCLE) subjects.
Measured: 253 Days
Characterize the mean change and variability in serum SS-A and SS-B autoantibodies.
Measured: 253 Days
Characterize change in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (CLASI-a) score.
Measured: 253 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LupusStudies 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 1
- Primary purpose
- Treatment
- 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
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389895
- Sponsor's protocol ID
- 20100037
- Status last verified
- Jan 2014
- First submitted
- 23 Jun 2011
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01389895
- Acronym / sponsor ID
- 20100037
- Conditions
- Cutaneous Lupus, Lupus
- Keywords
- Lupus, Cutaneous lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jul 2011 (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.
This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.
Detailed description
Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed. After Cohort 1 and 2 enrollment has been completed, the emerging PK and PD data will be reviewed to determine if an additional 4-8 subjects with SCLE will be enrolled into the study to address equivocal results from the study. These 4-8 additional subjects will receive the same dose of either 210 mg or 140 mg SC (in an allocation ratio of 1 AMG 557: 1 placebo).
In addition, an open label extension study for participants in this study may be instituted following completion and analysis of results of this study. Initiation of this study will require that an acceptable risk-benefit profile and some evidence of efficacy are observed in the current study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 557 | Active comparator | Drug: AMG 557All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. |
| AMG 557 Placebo | Placebo comparator | Drug: AMG 557 PlaceboAll will receive placebo on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
- Body mass index from 18 to 35 kg/m2 at screening;
- Diagnosis of subacute cutaneous lupus erythematosus (SCLE) with or without systemic lupus erythematosus (SLE). SCLE as defined by the Gilliam and Sontheimer classification (J Am Acad Dermatol 1981; 4(4):471-475). SLE is defined by the most recent American College of Rheumatology criteria, including positive antinuclear antibodies (ANA) during screening or by documented history (at least 1:80 by indirect immunofluorescent assay);
- A history of skin biopsy consistent with the diagnosis of SCLE;
- Positive SS-A and/or SS-B antibodies at screening;
Key exclusion criteria (11 listed)
- Drug-induced SCLE;
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SCLE, SLE, or Sjögren's syndrome) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion. This includes any age related co-morbidities such as presence of congestive heart failure, angina, chronic obstructive pulmonary disease, and asthma;
- Presence or history of vasculitis (comprising internal organs or extremities or leading to peripheral neuropathy) within the last 3 years, presence or history of active Central Nervous System (CNS) lupus (defined as seizure disorder, cerebral vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis) requiring therapy within the last 3 years;
- History of malignancy;
- Signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization, or recent history of repeated infections;
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 |
|---|---|---|
| AMG 557AMG 557 (210 mg) or (140 mg ) will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive AMG 557. Beginning on Day 1, subjects will receive either 210 mg AMG 557 or 140 mg AMG 557 once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of AMG 557 every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments. | Drug | AMG 557 |
| AMG 557 PlaceboAMG 557 Placebo (210 mg) or (140 mg )will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive placebo. Beginning on Day 1, subjects will receive placebo once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of placebo every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments. | Drug | AMG 557 Placebo |
Primary outcome
Safety evaluation: Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557
Time frame: 253 Days
3 secondary outcomes
Determine the pharmacokinetic (PK) profile of AMG 557 after multiple subcutaneous (SC) doses in subacute cutaneous lupus erythematosus (SCLE) subjects.
Time frame: 253 Days
Characterize the mean change and variability in serum SS-A and SS-B autoantibodies.
Time frame: 253 Days
Characterize change in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (CLASI-a) score.
Time frame: 253 Days
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Cutaneous Lupus
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
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
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 557 in people with Cutaneous Lupus and Lupus, run by Amgen at 10 sites in 3 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 10 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia, 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 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?
The study was stopped early (reason given: slow enrollment). 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 evaluation: Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557 (time frame: 253 Days). 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 10 Jan 2014.