Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NKTR-358, REZPEG, LY3471851 (formerly), LY3471851
Rezpegaldesleukin · 8 trials · 6 indications
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
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).
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
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).
| Arm | Type | Description |
|---|---|---|
| Blinded Induction Period: Rezpegaldesleukin every 2 weeks | EXPERIMENTAL | Rezpegaldesleukin every 2 weeks during the induction period |
| Blinded Induction Period: Placebo | PLACEBO_COMPARATOR | Placebo every 2 weeks during the induction period |
| Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks | EXPERIMENTAL | Rezpegaldesleukin every 4 weeks during the maintenance period |
| Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks | EXPERIMENTAL | Rezpegaldesleukin every 12 weeks during the maintenance period |
| Blinded Maintenance Period: Placebo | PLACEBO_COMPARATOR | Placebo every 4 weeks during the maintenance period |
| Open-Label Escape | EXPERIMENTAL | Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape |
| Low Dose | EXPERIMENTAL | Rezpegaldesleukin Low Dose Every 2 weeks |
| High Dose | EXPERIMENTAL | Rezpegaldesleukin High Dose Every 2 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo Every 2 weeks |
| Arm A | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period |
| Arm A1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period |
| Arm A2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period |
| Arm B | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period |
| Arm B1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period |
| Arm B2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period |
| Arm C | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period |
| Arm C1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period |
| Arm C2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period |
| Arm D | PLACEBO_COMPARATOR | Placebo every 2 weeks during the induction period |
| Arm D1 | PLACEBO_COMPARATOR | Placebo every 4 weeks during the maintenance period |
| Escape Therapy (open-label) | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period |
| LY3471851 High Dose | EXPERIMENTAL | LY3471851 administered subcutaneously (SC). |
| LY3471851 Mid Dose | EXPERIMENTAL | LY3471851 administered SC. |
| LY3471851 Low Dose | EXPERIMENTAL | LY3471851 administered SC |
| 10 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 12 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 24 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| Cohort 1 - 10 (Microgram Per Kilogram) μg/kg LY3471851 | EXPERIMENTAL | Participants received 10 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks. |
| Cohort 2 - 24 μg/kg LY3471851 | EXPERIMENTAL | Participants received 24 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Rezpegaldesleukin | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
| LY3471851 | DRUG | Administered SC |
Inclusion Criteria: * Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline * Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms ≥ 12 months prior to Screening as determined by the ...
Rezpegaldesleukin is an investigational therapy being studied for moderate to severe atopic dermatitis and severe to very severe alopecia areata. It is in clinical development and has not been approved by the FDA. Nektar Therapeutics holds Fast Track designation for the program.
Rezpegaldesleukin targets IL-2, or interleukin-2. By engaging the IL-2 pathway, the drug is designed to modulate immune cell activity relevant to inflammatory skin conditions such as atopic dermatitis and alopecia areata. It is being developed by Nektar Therapeutics.
Rezpegaldesleukin is being developed by Nektar Therapeutics, which trades under the ticker NKTR. The company is running clinical trials of the drug in atopic dermatitis and alopecia areata across multiple countries, including the United States, Canada, and several European nations.
Rezpegaldesleukin is in Phase 2 and Phase 3 clinical development. Two Phase 3 trials in moderate to severe atopic dermatitis are currently recruiting, while Phase 2b studies have been completed or are active but not recruiting. The drug remains investigational and has not received FDA approval.
Rezpegaldesleukin is being studied in several trials, including NCT07711418 and NCT07690371, both Phase 3 studies in moderate to severe atopic dermatitis. The Phase 2b Rezolve AA trial, NCT06340360, evaluated the drug in alopecia areata, and NCT06136741 is a Phase 2b study in atopic dermatitis.
Yes, Rezpegaldesleukin is also known as NKTR-358 and is sometimes referred to as Rezpeg. These names refer to the same investigational drug developed by Nektar Therapeutics for atopic dermatitis and alopecia areata. It is currently in Phase 2 and Phase 3 clinical testing.