Systemic Lupus ErythematosusPhase 1NCT00774943
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
A Phase 1 study testing AMG 557 in people with Systemic Lupus Erythematosus, run by Amgen at 12 sites in 2 countries.
Trial summary
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- 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
- 58 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Dec 2008to May 2012
- 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
- Before any study-specific procedure, the appropriate written informed consent must be obtained;
- Men and women, between the ages of 18 and 70 years old, inclusive, at the time of randomization;
- Diagnosis of SLE as defined by the most recent ACR criteria, including a positive ANA at screening or documented positive ANA (the titer should be at least 1:80) in the past.
- SLE duration of at least six months, as diagnosed by a physician;
- Stable disease, defined as no change in SLE therapy within the previous 30 days; and, in the opinion of the investigator, no anticipated need for a change in SLE therapy will be required while the subject is enrolled in the study;
- Normal or clinically acceptable ECG (12-lead reporting ventricular rate and PR, QRS, QT, QTc) at screening and Day -1 based on the opinion of the investigator;
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- Body mass index from 18 to 40 kg/m2 at screening;
- Able and willing to complete entire study according to study schedule.
- Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide) and influenza (during flu season) vaccinations, as determined by the Principal Investigator.
Who cannot join
- Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA);
- Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization;
- Evidence of active or latent tuberculosis as assessed by PPD or Quantiferon testing at screening;
- Have donated blood or experienced a loss of blood >500mL within 4 weeks of randomization;
- History of ethanol or drug abuse within the last one year prior to randomization;
- Evidence of significant renal insufficiency, defined by:
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- The glomerular fitration rate < 50 mL/min using the Cockroft and Gault equation;
- Evidence of liver disease (eg, serum ALT or AST > 2x upper limit of normal);
- Total WBC <3000 x 106/L;
- Neutrophil count < 1500 x106/L
- Platelet count <75,000 x 106/L
- Hemoglobin <10g/dL
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would, by it progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures in the medical judgment of the investigator. This includes any age related co-morbidites such as presence of congestive heart failure, angina, chronic obstructive pulmonary disease, asthma, and malignancies (other than resected squamous and basal cell carcinoma of the skin).
- 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 CNS lupus (defined as seizure disorder, cerebral vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis) requiring therapy within the last 3 years;
- Uncontrolled hypertension (Blood pressure > 150/95);
- Poorly controlled diabetes (HbA1c > 8%);
- Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis;
- Underlying condition that predisposes the subject to infections (eg, history of splenectomy);
- Any disorder or condition that prevents the subject from providing truly informed consent;
- Prior administration of any other biologic that primarily targets the immune system (eg, Lymphostat-B, TACI-Ig, or CTLA4-Ig) in the past 9 months. This includes prior administration of AMG 557;
- Presence of AMG 557 anti-bodies;
- Prior administration of rituximab > 9 months with CD19+ B cells <5/µL;
- Administration of cyclophosphamide (or any other alkylating agent), cyclosporine, tacrolimus, or sirolimus, or > 100 mg/day prednisone or equivalent in the 6 months prior to randomization;
- Participated in an investigational drug trial involving a monoclonal antibody (not targeting the immune system) within 3 months or 5 half-lives, whichever time period is longer, prior to randomization;
- Participated in any another investigational drug or device trial within the previous 30 days or 5 half-lives, whichever time period is longer, prior to randomization;
- Administration of >10 mg/day prednisone (or equivalent) in the 30 days prior to randomization;
- Known sensitivity to mammalian derived products;
- Unwilling to practice an effective method of double-barrier contraception as determined by the investigator for the duration of the study;
- Positive serum hCG at screening or positive urine hCG on D-1; or females who are currently lactating;
- Known allergies to shellfish or any excipients found in KLH;
- Previous immunization with KLH.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Research Site
Amarillo, Texas, 79124
Research Site
Anniston, Alabama, 36207
Research Site
Dallas, Texas, 75231
Research Site
Danbury, Connecticut, 06810
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Manhasset, New York, 11030
Research Site
Miami, Florida, 33143
Research Site
Michigan City, Indiana, 46360
Research Site
Phoenix, Arizona, 85013
Research Site
Rochester, New York, 14642
Research Site
San Leandro, California, 94578
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- AMG 557
- Keywords
- Systemic lupus erythematosus, ICOSL, B7RP-1, Costimulation
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 557Drug
A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.
| Study group | Role | What they receive |
|---|---|---|
| AMG 557 | Active comparator | Not described Receives: Drug: AMG 557 |
| Placebo | Placebo comparator | Not described Receives: Drug: AMG 557 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.
Measured: Throughout study period
Secondary outcomes (1)
Serum PK profile of AMG 557 after multiple dose administrations. Biomarkers of pharmacodynamic activity for AMG 557.
Measured: Throughout study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 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
- NCT00774943
- Sponsor's protocol ID
- 20060169
- Status last verified
- Apr 2013
- First submitted
- 16 Oct 2008
- Last updated
- 9 Apr 2013
- Results posted
- No
Publications
Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016.
PubMed 27099766Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.
PubMed 26138472
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00774943
- Acronym / sponsor ID
- 20060169
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, ICOSL, B7RP-1, Costimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Oct 2008 (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 is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 557 | Active comparator | Drug: AMG 557 |
| Placebo | Placebo comparator | Drug: AMG 557 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Before any study-specific procedure, the appropriate written informed consent must be obtained;
- Men and women, between the ages of 18 and 70 years old, inclusive, at the time of randomization;
- Diagnosis of SLE as defined by the most recent ACR criteria, including a positive ANA at screening or documented positive ANA (the titer should be at least 1:80) in the past.
- SLE duration of at least six months, as diagnosed by a physician;
- Stable disease, defined as no change in SLE therapy within the previous 30 days; and, in the opinion of the investigator, no anticipated need for a change in SLE therapy will be required while the subject is enrolled in the study;
Key exclusion criteria (31 listed)
- Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA);
- Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization;
- Evidence of active or latent tuberculosis as assessed by PPD or Quantiferon testing at screening;
- Have donated blood or experienced a loss of blood >500mL within 4 weeks of randomization;
- History of ethanol or drug abuse within the last one year prior to randomization;
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 557A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort. | Drug | AMG 557, Placebo |
Primary outcome
Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.
Time frame: Throughout study period
1 secondary outcome
Serum PK profile of AMG 557 after multiple dose administrations. Biomarkers of pharmacodynamic activity for AMG 557.
Time frame: Throughout study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Derived from this study: PubMed 27099766Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016.
- Derived from this study: PubMed 26138472Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.
- 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
12 sites in 2 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 Systemic Lupus Erythematosus, run by Amgen at 12 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 9 inclusion and 31 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557. (time frame: Throughout study period). 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 NCT00774943, which also lists 2 linked publications.
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 9 Apr 2013.