Systemic Lupus ErythematosusPhase 1NCT02618967

Single Ascending Dose Study of AMG 570 in Healthy Subjects

A Phase 1 study testing AMG 570 in people with Systemic Lupus Erythematosus, run by Amgen at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: AMG 570
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 3 sitesUnited States
Study dates: 28 Mar 2016to 3 Dec 2018
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy as determined by the investigator
Normal or clinically acceptable electrocardiogram (ECG)
Female subjects must be of documented non-reproductive potential
Subjects must be current for all vaccinations
Other inclusion criteria may apply

Who cannot join

Current or chronic history of liver disease
History of active infections
History of significant respiratory disorder
Evidence of renal disease
Other exclusion criteria may apply

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Research Site
Evansville, Indiana, 47710
Research Site
Madison, Wisconsin, 53704
Research Site
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects

Conditions: Systemic Lupus Erythematosus
Being tested: AMG 570, AMG 570 Matching Placebo
Keywords: Lupus, Healthy Volunteer, Safety Study, Placebo Control, Phase 1
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 570Biological
Also called Active Comparator, Investigational Product, and Study drug
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
AMG 570 Matching PlaceboBiological
Also called Placebo, Investigational Product, and Study drug
Placebo administered as single dose subcutaneous in healthy volunteers.

Study groups in NCT02618967
Study group	Role	What they receive
AMG 570 - 7 mg	Experimental	Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 21 mg	Experimental	Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 70 mg	Experimental	Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 140 mg	Experimental	Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 210 mg	Experimental	Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 420 mg	Experimental	Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
AMG 570 - 700 mg	Experimental	Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously. Receives: Biological: AMG 570
Placebo	Placebo comparator	Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously. Receives: Biological: AMG 570 Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
TEAEs were adverse events with an onset after the administration of study treatment.
TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.
Grade 4 Life-threatening consequences; urgent interventions indicated.
Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:
- Results in death (fatal)
- Immediately life-threatening
- Requires in-patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Other medically important serious event
Measured: Day 1 to Day 105
Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Measured: Baseline to Day 105
Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.
Measured: Baseline to Day 105
Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit.
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.
Grade 4 Life-threatening consequences; urgent interventions indicated.
Measured: Baseline to Day 105
Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.
Measured: Baseline to Day 105

Secondary outcomes (8)

Maximum Observed Concentration (Cmax) of AMG 570
AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Measured: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Time to Reach Maximum Observed Concentration (Tmax) of AMG 570
AMG 570 PK parameters were estimated using non-compartmental analysis.
Measured: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570
AMG 570 PK parameters were estimated using non-compartmental analysis.
Measured: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570
Measured: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented.
Measured: Baseline to Day 105
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Peripheral B7RP1 (also known as inducible costimulator ligand [ICOSL]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood.
Measured: Day 8; Day 29; Day 57; and Day 105
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Measured: Baseline to Day 8; Day 29; Day 57 and Day 105
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Measured: Baseline to Day 8; Day 29; Day 57 and Day 105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 20163 Dec 2018

First posted2 Dec 2015 (estimated)
Study start28 Mar 2016
Primary completion6 Sep 2018
Study completion3 Dec 2018

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 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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02618967
Sponsor's protocol ID: 20140322
Status last verified: May 2024
First submitted: 13 Oct 2015
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.
PubMed 37150935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects
ClinicalTrials.gov ID: NCT02618967
Acronym / sponsor ID: 20140322
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus, Healthy Volunteer, Safety Study, Placebo Control, Phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 28 Mar 2016 (actual)
Primary completion: 6 Sep 2018 (actual)
Study completion: 3 Dec 2018 (actual)
First posted: 2 Dec 2015 (estimated)
Results: Posted 15 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
AMG 570 - 7 mg	Experimental	Biological: AMG 570Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 21 mg	Experimental	Biological: AMG 570Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 70 mg	Experimental	Biological: AMG 570Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 140 mg	Experimental	Biological: AMG 570Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 210 mg	Experimental	Biological: AMG 570Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 420 mg	Experimental	Biological: AMG 570Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.
AMG 570 - 700 mg	Experimental	Biological: AMG 570Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously.
Placebo	Placebo comparator	Biological: AMG 570 Matching PlaceboParticipants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy as determined by the investigator
Normal or clinically acceptable electrocardiogram (ECG)
Female subjects must be of documented non-reproductive potential
Subjects must be current for all vaccinations
Other inclusion criteria may apply

Key exclusion criteria (5 listed)

Current or chronic history of liver disease
History of active infections
History of significant respiratory disorder
Evidence of renal disease
Other exclusion criteria may apply

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 570Also: Active Comparator, Investigational Product, and Study drug7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.	Biological	AMG 570 - 140 mg, AMG 570 - 21 mg, AMG 570 - 210 mg, AMG 570 - 420 mg, AMG 570 - 7 mg, AMG 570 - 70 mg, AMG 570 - 700 mg
AMG 570 Matching PlaceboAlso: Placebo, Investigational Product, and Study drugPlacebo administered as single dose subcutaneous in healthy volunteers.	Biological	Placebo

Primary outcome

Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 105
TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
Time frame: Baseline to Day 105
Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
Time frame: Baseline to Day 105
Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.
Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
Time frame: Baseline to Day 105
Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
Time frame: Baseline to Day 105
Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.

8 secondary outcomes

Maximum Observed Concentration (Cmax) of AMG 570
Time frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Time to Reach Maximum Observed Concentration (Tmax) of AMG 570
Time frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570
Time frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570
Time frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
Time frame: Baseline to Day 105
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Time frame: Day 8; Day 29; Day 57; and Day 105
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Time frame: Baseline to Day 8; Day 29; Day 57 and Day 105
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Time frame: Baseline to Day 8; Day 29; Day 57 and Day 105

Results and safety

Results posted to the registry on 15 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMG 570 - 7 mg	6	5
AMG 570 - 21 mg	6	6
AMG 570 - 70 mg	6	5
AMG 570 - 140 mg	6	6
AMG 570 - 210 mg	6	4
AMG 570 - 420 mg	6	6
AMG 570 - 700 mg	6	6
Placebo	14	14

Primary outcome: Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)

Time frame: Day 1 to Day 105. Count of participants. Unit: Participants

Measure	AMG 570 - 7 mg n = 6	AMG 570 - 21 mg n = 6	AMG 570 - 70 mg n = 6	AMG 570 - 140 mg n = 6	AMG 570 - 210 mg n = 6	AMG 570 - 420 mg n = 6	AMG 570 - 700 mg n = 6	Placebo n = 14
TEAEs	6	5	4	4	2	3	4	9
Grade ≥ 2 TEAEs	4	0	1	1	0	0	1	3
Grade ≥ 3 TEAEs	0	0	0	0	0	0	1	0
Grade ≥ 4 TEAEs	0	0	0	0	0	0	0	0
SAEs	1	0	0	0	0	0	0	0
Life-threatening TEAEs	0	0	0	0	0	0	0	0
Fatal TEAEs	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set: all participants who received AMG 570 or placebo.

Primary outcome: Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations

Time frame: Baseline to Day 105. Count of participants. Unit: Participants

Measure	AMG 570 - 7 mg n = 6	AMG 570 - 21 mg n = 6	AMG 570 - 70 mg n = 6	AMG 570 - 140 mg n = 6	AMG 570 - 210 mg n = 6	AMG 570 - 420 mg n = 6	AMG 570 - 700 mg n = 6	Placebo n = 14
Value	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set: all participants who received AMG 570 or placebo.

Primary outcome: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs

Time frame: Baseline to Day 105. Count of participants. Unit: Participants

Measure	AMG 570 - 7 mg n = 6	AMG 570 - 21 mg n = 6	AMG 570 - 70 mg n = 6	AMG 570 - 140 mg n = 6	AMG 570 - 210 mg n = 6	AMG 570 - 420 mg n = 6	AMG 570 - 700 mg n = 6	Placebo n = 14
Value	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set: all participants who received AMG 570 or placebo.

Primary outcome: Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests

Time frame: Baseline to Day 105. Count of participants. Unit: Participants

Measure	AMG 570 - 7 mg n = 6	AMG 570 - 21 mg n = 6	AMG 570 - 70 mg n = 6	AMG 570 - 140 mg n = 6	AMG 570 - 210 mg n = 6	AMG 570 - 420 mg n = 6	AMG 570 - 700 mg n = 6	Placebo n = 14
Value	0	0	0	0	0	0	0	3

Population analysed: Safety analysis set: all participants who received AMG 570 or placebo.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 105 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMG 570 - 7 mg	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
AMG 570 - 21 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
AMG 570 - 70 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
AMG 570 - 140 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
AMG 570 - 210 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
AMG 570 - 420 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
AMG 570 - 700 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Placebo	0 of 14 (0%)	9 of 14 (64.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37150935Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic 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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 570 in people with Systemic Lupus Erythematosus, run by Amgen at 3 sites in United States.

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 5 inclusion and 5 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 15 Oct 2021). 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?

Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 to Day 105). The study lists 5 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 NCT02618967, 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 14 May 2024.