Systemic Lupus ErythematosusPhase 1NCT02391259
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing AMG 557 in people with Systemic Lupus Erythematosus, run by Amgen at 13 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts 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
- 57 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Nov 2006to Nov 2011
- 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
- Diagnosis of SLE with positive ANA
- Stable disease with no change in SLE therapy within the previous 30 days
- BMI from 18 to 38 kg/m2
Who cannot join
- Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
- Evidence of renal disease or liver disease
- Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
- Prior administration of any other biologic that primarily targets the immune system
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Research Site
Anniston, Alabama, 36207
Research Site
Dallas, Texas, 75231
Research Site
Dallas, Texas, 75247
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Los Angeles, California, 90033
Research Site
Los Angeles, California, 90048
Research Site
Manhasset, New York, 11030
Research Site
Michigan City, Indiana, 46360
Research Site
New York, New York, 10003
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Phoenix, Arizona, 85013
Research Site
Rochester, New York, 14642
About this study
Official title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- AMG 557, Placebo
- 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
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
PlaceboDrug
contains no active drug
| Study group | Role | What they receive |
|---|---|---|
| AMG 557 | Experimental | AMG 557 administered as subcutaneous and intravenous doses. Receives: Drug: AMG 557 |
| Placebo | Placebo comparator | No active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
Measured: From 29 days to 169 days
Secondary outcomes (1)
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Serum concentration and derived PK parameters including Tmax, AUClast and Cmax
Measured: From 29 days to 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2006
- Primary completionSep 2011
- Study completionNov 2011
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 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
- NCT02391259
- Sponsor's protocol ID
- 20060132
- Status last verified
- Mar 2015
- First submitted
- 6 Jan 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- 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 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02391259
- Acronym / sponsor ID
- 20060132
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Mar 2015 (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 multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 557 | Experimental | Drug: AMG 557AMG 557 administered as subcutaneous and intravenous doses. |
| Placebo | Placebo comparator | Drug: PlaceboNo active drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of SLE with positive ANA
- Stable disease with no change in SLE therapy within the previous 30 days
- BMI from 18 to 38 kg/m2
Key exclusion criteria (4 listed)
- Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
- Evidence of renal disease or liver disease
- Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
- Prior administration of any other biologic that primarily targets the immune system
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 is for the treatment of sybjects with systemic lupus erythematosus | Drug | AMG 557 |
| Placebocontains no active drug | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: From 29 days to 169 days
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
1 secondary outcome
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Time frame: From 29 days to 169 days
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 30 Mar 2015.
- 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
13 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 13 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 3 inclusion and 4 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom. 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?
Safety and tolerability (time frame: From 29 days to 169 days). 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 NCT02391259, 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 30 Mar 2015.