Systemic Lupus ErythematosusPhase 1NCT03556007
A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing LY3471851 in people with Systemic Lupus Erythematosus, run by Nektar Therapeutics at 14 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in participants with SLE. The study will last about 79 days for each participant. 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?
- LY3471851
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Apr 2018to 29 Aug 2019
- 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
- Willing and able to give written informed consent and comply with study procedures and requirements.
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
- Systolic blood pressure between 90 to 140 millimeters of mercury (mm Hg), diastolic blood pressure between 50 to 90 mm Hg, and resting heart rate between 40 to 100 beats per minute.
- Diagnosis of adult SLE according to the 1997 ACR classification criteria for at least 6 months prior to signing the informed consent form (ICF).
- Minimal to moderate SLE disease activity (active SLE clinical disease is not required for enrollment into the study and participants with severe SLE clinical disease activity, based on the evaluation of the investigator, should be excluded).
- If a participant is taking oral prednisone (or prednisone equivalent) for their SLE, the dose must be less than or equal to (≤) 10 milligrams per day (mg/day) for a minimum of 8 weeks prior to screening. In addition, the dose of oral prednisone or prednisone equivalent the participant is taking must be stable for a minimum of 2 weeks prior to screening.
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- If a participant is taking any of the medications below for their SLE, the medication must have been administered for a minimum of 12 weeks prior to signing the ICF, and at a stable dose for a minimum of 8 weeks prior to signing the ICF:
- Azathioprine ≤ 200 mg/day
- Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine)
- Mycophenolate mofetil ≤ 2 grams per day (g/day) or mycophenolic acid ≤ 1.44 g/day
- Oral, SC, or intramuscular methotrexate ≤ 15 milligrams per week (mg/week).
- Willing and able to participate in the study for a duration of up to 4 months.
- Willing and able to abstain from participating in another clinical study for a duration of up to 4 months.
- Female participants will be non-pregnant, non-lactating, and either postmenopausal for at least 2 years, or surgically sterile for at least 3 months, or will agree to use double barrier contraception from period prior to study enrollment until 5 months following the last dose received; women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and randomization prior to administration of investigational product.
- Male participants with female partners of childbearing potential must agree to use double barrier contraception during the study (until 5 months following the last dose received). Sperm donation is also restricted during the time-frame that males must be using double barrier contraception. This criterion may be waived for male participants who have had a vasectomy greater than (>) 6 months prior to enrollment.
Who cannot join
- Medical Conditions:
- Current active bacterial, viral, or fungal infection.
- Evidence of significant hematologic dysfunction.
- Evidence of significant liver or kidney dysfunction.
- History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome.
- Active severe or unstable neuropsychiatric SLE.
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- Active severe SLE-driven renal disease or history of severe active lupus nephritis with persisting proteinuria levels greater than 0.5 grams/24 hours.
- Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any history of overlap syndromes of SLE.
- History of, or current, inflammatory joint or skin disease other than SLE.
- History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 24 weeks prior to signing the ICF.
- Active tuberculosis (TB) on the basis of positive medical history or chest radiograph (OR) evidence of latent TB or by positive (or persistently indeterminate) Quantiferon-TB Gold or T-Spot test.
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.
- Confirmed positive serology for hepatitis B, hepatitis C (Viral Hepatitis C Antibody Screen [anti-HCV]), or a positive result for human immunodeficiency virus (HIV) antibody screen.
- Any severe herpes infection at any time prior to screening per judgement of the investigator.
- History of opportunistic infection requiring hospitalization or intravenous antimicrobial treatment within 3 years prior to randomization.
- History of major surgery within 12 weeks of screening or will require major surgery during the study.
- Clinically significant electrocardiographic abnormalities.
- History of any significant cardiovascular disease (e.g., myocardial infarction, congestive heart failure, uncontrolled hypertension, cerebrovascular accident), thrombotic episode, or any severe non-SLE medical illness within the previous 1 year.
- History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin that has been successfully treated.
- Cervical cancer in situ that has been successfully treated.
- Medications:
- Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.
- Receipt of belimumab in 6 months prior to screening.
- History of treatment with rituximab or ocrelizumab (or other B cell depleting agent) within 6 months prior to screening. For participants who received their last treatment with rituximab or ocrelizumab more than 6 months earlier, evidence of significant and persisting low B cell levels in blood.
- History of cytotoxic medications (e.g., cyclophosphamide) within preceding 12 months.
- Receipt of any intra-articular, intramuscular, or intravenous (IV) glucocorticoids within 6 weeks prior to screening.
- Receipt of blood products within 6 months prior to screening.
- General:
- Receipt of blood products within 6 months prior to screening and donation of blood or plasma to a blood bank or for a clinical study (except for screening of this study) within 28 days prior to screening.
- Participants who have a history of organ or bone marrow transplant.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Investigator Site - Anniston
Anniston, Alabama, 36207
Investigator Site - Austin
Austin, Texas, 78745
Investigator Site - Clearwater
Clearwater, Florida, 33765
Investigator Site - Dallas
Dallas, Texas, 75231
Investigator Site - Duncansville
Duncansville, Pennsylvania, 16635
Investigator Site - Great Neck
Great Neck, New York, 11021
Investigator Site - Jackson
Jackson, Tennessee, 38305
Investigator Site - La Jolla
La Jolla, California, 92037
Investigator Site - Memphis
Memphis, Tennessee, 38119
Investigator Site - Mesquite
Mesquite, Texas, 75150
Investigator Site - Middleburg Heights
Middleburg Heights, Ohio, 44130
Investigator Site - Orlando
Orlando, Florida, 32806
Investigator Site-Tampa
Tampa, Florida, 33603
Investigator Site- Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus
The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in participants with SLE. The study will last about 79 days for each participant.
Read the detailed description
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and immunologic effects of multiple doses of LY3471851 in participants with minimal to moderate SLE. The effects on SLE disease activity will also be evaluated. SLE participants will be randomized to receive multiple subcutaneous (SC) doses of LY3471851 or receive placebo. After receiving the last dose of LY3471851 or placebo, participants will be followed for an additional 50 days to evaluate safety, PK, pharmacodynamics (PD), and preliminary efficacy.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- LY3471851, Placebo
- Keywords
- T regulatory cells
- 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.
LY3471851Drug
Also called NKTR-358
LY3471851 drug product is a sterile liquid for subcutaneous injection that will be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.
PlaceboDrug
The placebo dosing solution is 0.9% sodium chloride for injection (USP).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 3 μg/kg LY3471851 | Experimental | Participants received 3 microgram per kilogram (μg/kg) of LY3471851 or placebo on days 1, 15 and 29 by subcutaneous (SC) injection. Receives: Drug: LY3471851; Drug: Placebo |
| Cohort 1 - 6 μg/kg LY3471851 | Experimental | Participants received 6 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. Receives: Drug: LY3471851; Drug: Placebo |
| Cohort 1 - 12 μg/kg LY3471851 | Experimental | Participants received 12 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. Receives: Drug: LY3471851; Drug: Placebo |
| Cohort 1 - 24 μg/kg LY3471851 | Experimental | Participants received 24 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. Receives: Drug: LY3471851; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of LY3471851 - Number of Participants Experiencing Adverse Events
Safety and tolerability of LY3471851 as assessed through collection of adverse events, serious adverse events, change in vital signs (body temperature, blood pressure, heart rate, rate of breathing and oxygen in blood); electrocardiograms (ECG); laboratory evaluations (hematology, chemistry, liver function and urine analysis).
Measured: Informed consent until last study visit (approximately 79 days after first dose of study drug)
Secondary outcomes (20)
Pharmacokinetics (PK): Area Under the Drug Concentration - Time Curve from Zero to the End of Dosing Interval (i.e, 14 days past each dose) (AUC[0-Day 14]) of LY3471851
PK measurement of AUC 0-Day 14
Measured: Baseline until 14 days after last dose (approximately 43 days after first dose of study drug)
PK: Maximum Observed Drug Concentration (Cmax) of LY3471851 After First and Last Dose
PK: Measurement of Cmax
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PK: Time to Maximum Plasma Concentration (Tmax) of LY3471851
PK: Measurement of Tmax
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PK: Time to Decrease in Concentration of LY3471851 by Half (T1/2) Due to Elimination
PK: Measurement of T1/2
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Pharmacodynamics (PD): Measurement of Change in Number of Regulatory T Cells (Tregs) and Subsets of Tregs in Blood
PD: Measurement of Change in Number of Regulatory T Cells (Tregs) and Subsets of Tregs in Blood
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement Activity of Tregs
PD: Measurement Activity of Tregs
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Change in Number of Subsets of Conventional T Cells (Tcons) in Blood
PD: Measurement of Change in Number of Subsets of Conventional T Cells
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood
PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Cytokines in Blood
PD: Measurement of Cytokines in Blood
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (SLEDAI): Urine; Measurement of Hematuria, Pyuria, Urinary Casts, Creatinine, Protein
Change in Disease Activity (SLEDAI): Urine; Measurement of Hematuria, Pyuria, Urinary Casts, Creatinine, Protein
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (SLEDAI): Blood: Measurement of Anti-dsDNA, Complement, White Blood Cells and Platelets
Change in Disease Activity (SLEDAI): Blood: Measurement of Anti-dsDNA, Complement, White Blood Cells and Platelets
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Physical Examination
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Physical Examination
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Urine Analysis
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Urine Analysis
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Blood Analysis
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Blood Analysis
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Skin on the Body
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Skin on the Body
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Mucous Membrane
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Mucous Membrane
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Scalp
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Scalp
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Hair Loss
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Hair Loss
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Joint score): Evaluation of Tender Joints in the Body
Change in Disease Activity (Joint score): Evaluation of Tender Joints in the Body
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Joint Score): Evaluation of Swollen Joints in the Body
Change in Disease Activity (Joint Score): Evaluation of Swollen Joints in the Body
Measured: Baseline until last study visit (approximately 79 days after first dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start18 Apr 2018
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556007
- Sponsor's protocol ID
- 17238
- Other IDs
- J1P-MC-KFAB, 17-358-02
- Status last verified
- Nov 2023
- First submitted
- 7 May 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03556007
- Acronym / sponsor ID
- 17238
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- T regulatory cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 14 Jun 2018 (actual)
- 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.
The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in participants with SLE. The study will last about 79 days for each participant.
Detailed description
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and immunologic effects of multiple doses of LY3471851 in participants with minimal to moderate SLE. The effects on SLE disease activity will also be evaluated. SLE participants will be randomized to receive multiple subcutaneous (SC) doses of LY3471851 or receive placebo. After receiving the last dose of LY3471851 or placebo, participants will be followed for an additional 50 days to evaluate safety, PK, pharmacodynamics (PD), and preliminary efficacy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 3 μg/kg LY3471851 | Experimental | Drug: LY3471851, Drug: PlaceboParticipants received 3 microgram per kilogram (μg/kg) of LY3471851 or placebo on days 1, 15 and 29 by subcutaneous (SC) injection. |
| Cohort 1 - 6 μg/kg LY3471851 | Experimental | Drug: LY3471851, Drug: PlaceboParticipants received 6 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
| Cohort 1 - 12 μg/kg LY3471851 | Experimental | Drug: LY3471851, Drug: PlaceboParticipants received 12 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
| Cohort 1 - 24 μg/kg LY3471851 | Experimental | Drug: LY3471851, Drug: PlaceboParticipants received 24 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to give written informed consent and comply with study procedures and requirements.
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
- Systolic blood pressure between 90 to 140 millimeters of mercury (mm Hg), diastolic blood pressure between 50 to 90 mm Hg, and resting heart rate between 40 to 100 beats per minute.
- Diagnosis of adult SLE according to the 1997 ACR classification criteria for at least 6 months prior to signing the informed consent form (ICF).
- Minimal to moderate SLE disease activity (active SLE clinical disease is not required for enrollment into the study and participants with severe SLE clinical disease activity, based on the evaluation of the investigator, should be excluded).
Key exclusion criteria (31 listed)
- Current active bacterial, viral, or fungal infection.
- Evidence of significant hematologic dysfunction.
- Evidence of significant liver or kidney dysfunction.
- History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome.
- Active severe or unstable neuropsychiatric SLE.
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 |
|---|---|---|
| LY3471851Also: NKTR-358LY3471851 drug product is a sterile liquid for subcutaneous injection that will be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration. | Drug | Cohort 1 - 12 μg/kg LY3471851, Cohort 1 - 24 μg/kg LY3471851, Cohort 1 - 3 μg/kg LY3471851, Cohort 1 - 6 μg/kg LY3471851 |
| PlaceboThe placebo dosing solution is 0.9% sodium chloride for injection (USP). | Drug | Cohort 1 - 12 μg/kg LY3471851, Cohort 1 - 24 μg/kg LY3471851, Cohort 1 - 3 μg/kg LY3471851, Cohort 1 - 6 μg/kg LY3471851 |
Primary outcome
Safety and Tolerability of LY3471851 - Number of Participants Experiencing Adverse Events
Time frame: Informed consent until last study visit (approximately 79 days after first dose of study drug)
Safety and tolerability of LY3471851 as assessed through collection of adverse events, serious adverse events, change in vital signs (body temperature, blood pressure, heart rate, rate of breathing and oxygen in blood); electrocardiograms (ECG); laboratory evaluations (hematology, chemistry, liver function and urine analysis).
20 secondary outcomes
Pharmacokinetics (PK): Area Under the Drug Concentration - Time Curve from Zero to the End of Dosing Interval (i.e, 14 days past each dose) (AUC[0-Day 14]) of LY3471851
Time frame: Baseline until 14 days after last dose (approximately 43 days after first dose of study drug)
PK: Maximum Observed Drug Concentration (Cmax) of LY3471851 After First and Last Dose
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PK: Time to Maximum Plasma Concentration (Tmax) of LY3471851
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PK: Time to Decrease in Concentration of LY3471851 by Half (T1/2) Due to Elimination
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Pharmacodynamics (PD): Measurement of Change in Number of Regulatory T Cells (Tregs) and Subsets of Tregs in Blood
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement Activity of Tregs
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Change in Number of Subsets of Conventional T Cells (Tcons) in Blood
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
PD: Measurement of Cytokines in Blood
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (SLEDAI): Urine; Measurement of Hematuria, Pyuria, Urinary Casts, Creatinine, Protein
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (SLEDAI): Blood: Measurement of Anti-dsDNA, Complement, White Blood Cells and Platelets
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Physical Examination
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Urine Analysis
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): Blood Analysis
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Skin on the Body
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Mucous Membrane
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Scalp
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI): Evaluation of Hair Loss
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Joint score): Evaluation of Tender Joints in the Body
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
Change in Disease Activity (Joint Score): Evaluation of Swollen Joints in the Body
Time frame: Baseline until last study visit (approximately 79 days after first dose of study drug)
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Nektar Therapeutics
14 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 LY3471851 in people with Systemic Lupus Erythematosus, run by Nektar Therapeutics at 14 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 15 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. 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 of LY3471851 - Number of Participants Experiencing Adverse Events (time frame: Informed consent until last study visit (approximately 79 days after first dose of study drug)). 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 18 Nov 2023.