A Phase 2 interventional study of LY3471851 and Placebo in Systemic Lupus Erythematosus, sponsored by Nektar Therapeutics. Completed at 112 sites in 19 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Nektar Therapeutics · Phase 2, Interventional, and Treatment
The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).
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.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 291 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Nektar Therapeutics is the lead sponsor of 39 studies on the registry; 2 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LY3471851 administered subcutaneously (SC).
Drug: LY3471851
LY3471851 administered SC.
Drug: LY3471851
LY3471851 administered SC
Drug: LY3471851
Placebo administered SC.
Drug: Placebo
Administered SC
Also known as: Rezpegaldesleukin, REZPEG, NKTR-358
Administered SC
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Time frame: Week 24
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K. * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).
Time frame: Week 24
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K \>= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points \[10 mm\] from baseline.
Time frame: Week 24
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.
Time frame: Week 24
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
Time frame: Week 24
The study consisted of a 24-week treatment period: participants randomly received either high dose LY3471851 or mid dose LY3471851 or low dose LY3471851 or placebo.
| Milestone | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Started | 73 | 70 | 74 | 74 |
| Completed | 44 | 57 | 55 | 65 |
| Not completed | 29 | 13 | 19 | 9 |
| Withdrew: Withdrawal by subject | 15 | 3 | 15 | 6 |
| Withdrew: Adverse event | 10 | 4 | 1 | 0 |
| Withdrew: Due to the conflict in ukraine | 2 | 1 | 1 | 2 |
| Withdrew: Physician decision | 1 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 | 1 |
| Withdrew: Death | 0 | 1 | 0 | 0 |
Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
| Participants | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 | 20 | 27 | 22 | 22 |
Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K. * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).
| Participants | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24. | 12 | 26 | 18 | 18 |
Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K \>= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points \[10 mm\] from baseline.
| Participants | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24 | 20 | 27 | 22 | 22 |
Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.
| Participants | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24 | 12 | 18 | 11 | 10 |
LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
| ng/mL | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose |
|---|---|---|---|
| Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 | 214.4 ± 96.7 | 133.3 ± 50.6 | 55.9 ± 30.6 |
Collected over Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY3471851 High Dose | 0/73 (0%) | 3/73 (4.1%) | 54/73 (74%) |
| LY3471851 Mid Dose | 1/70 (1.4%) | 7/70 (10%) | 48/70 (68.6%) |
| LY3471851 Low Dose | 0/74 (0%) | 1/74 (1.4%) | 42/74 (56.8%) |
| Placebo | 0/74 (0%) | 5/74 (6.8%) | 40/74 (54.1%) |
| Event | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| COVID-19Infections and infestations | 0/73 | 1/70 | 0/74 | 0/74 |
| Gastric disorderGastrointestinal disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| Injection site reactionGeneral disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| PyrexiaGeneral disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 0/73 | 1/70 | 0/74 | 1/74 |
| HeadacheNervous system disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| PolyneuropathyNervous system disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| Cutaneous lupus erythematosusSkin and subcutaneous tissue disorders | 0/73 | 1/70 | 0/74 | 0/74 |
| COVID-19 pneumoniaInfections and infestations | 1/73 | 0/70 | 0/74 | 0/74 |
| PyelonephritisInfections and infestations | 1/73 | 0/70 | 0/74 | 0/74 |
| Event | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo |
|---|---|---|---|---|
| Injection site reactionGeneral disorders | 12/73 | 5/70 | 2/74 | 0/74 |
| PyrexiaGeneral disorders | 11/73 | 7/70 | 3/74 | 0/74 |
| COVID-19Infections and infestations | 3/73 | 8/70 | 4/74 | 5/74 |
| FatigueGeneral disorders | 6/73 | 1/70 | 3/74 | 0/74 |
| NasopharyngitisInfections and infestations | 5/73 | 0/70 | 1/74 | 2/74 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/73 | 1/70 | 5/74 | 1/74 |
| Urinary tract infectionInfections and infestations | 4/73 | 2/70 | 4/74 | 5/74 |
| DiarrhoeaGastrointestinal disorders | 1/73 | 2/70 | 5/74 | 1/74 |
| Upper respiratory tract infectionInfections and infestations | 1/73 | 4/70 | 3/74 | 2/74 |
| PainGeneral disorders | 2/73 | 4/70 | 1/74 | 1/74 |
| Age, Categorical(Participants) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 72 | 69 | 74 | 72 | 287 |
| >=65 years | 1 | 1 | 0 | 2 | 4 |
| Age, Continuous(years) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 40.0 ± 11.4 | 41.3 ± 13.0 | 39.9 ± 12.0 | 41.6 ± 12.0 | 40.7 ± 12.1 |
| Sex: Female, Male(Participants) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Female | 68 | 64 | 69 | 67 | 268 |
| Male | 5 | 6 | 5 | 7 | 23 |
| Ethnicity (NIH/OMB)(Participants) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 9 | 11 | 4 | 11 | 35 |
| Not Hispanic or Latino | 5 | 3 | 11 | 5 | 24 |
| Unknown or Not Reported | 59 | 56 | 59 | 58 | 232 |
| Race (NIH/OMB)(Participants) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 7 | 4 | 7 | 23 |
| Asian | 15 | 14 | 20 | 16 | 65 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 3 | 4 | 6 | 5 | 18 |
| White | 49 | 45 | 44 | 46 | 184 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | LY3471851 High Dose | LY3471851 Mid Dose | LY3471851 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Argentina | 13 | 11 | 12 | 8 | 44 |
| Romania | 2 | 2 | 4 | 6 | 14 |
| Hungary | 0 | 1 | 0 | 1 | 2 |
| United States | 14 | 14 | 15 | 16 | 59 |
| Czechia | 1 | 0 | 1 | 3 | 5 |
| Japan | 6 | 3 | 6 | 4 | 19 |
| Ukraine | 10 | 7 | 8 | 10 | 35 |
| India | 8 | 8 | 12 | 10 | 38 |
| Spain | 1 | 1 | 0 | 0 | 2 |
| Russia | 1 | 3 | 0 | 1 | 5 |
| Canada | 1 | 0 | 0 | 0 | 1 |
| South Korea | 0 | 1 | 1 | 1 | 3 |
| Taiwan | 1 | 2 | 1 | 1 | 5 |
| Poland | 4 | 7 | 5 | 0 | 16 |
| Mexico | 7 | 9 | 8 | 12 | 36 |
| Israel | 1 | 0 | 0 | 1 | 2 |
| Australia | 0 | 0 | 1 | 0 | 1 |
| Germany | 3 | 1 | 0 | 0 | 4 |
Showing the first 100 of 112 sites across 19 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in Jan 2023, 28 months.
Results were first posted in Apr 2024, 1 year 3 months after primary completion.
Of 67 industry-sponsored phase 2 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 48. This study's 28 months is below that.
Counting every sponsor, half of 95 studies reached it within 36 months; a quarter within 27 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rezpegaldesleukin
Lupus Erythematosus, Systemic →