Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rezpegaldesleukin · 4 trials · 3 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.
| 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 |
| Name | Type | Description |
|---|---|---|
| Rezpegaldesleukin | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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 drug being developed for moderate-to-severe atopic dermatitis and severe to very severe alopecia areata. It is currently in Phase 2 and Phase 3 clinical trials for these dermatological conditions.
Rezpegaldesleukin is being developed by Nektar Therapeutics, a biopharmaceutical company traded on the NASDAQ under the ticker symbol NKTR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with atopic dermatitis and alopecia areata.
Rezpegaldesleukin is in Phase 2 and Phase 3 clinical development. It has completed Phase 2b trials for atopic dermatitis and alopecia areata, and Phase 3 trials for atopic dermatitis are currently recruiting patients. The drug has not yet been approved by the FDA and remains investigational.
Rezpegaldesleukin is being studied in several clinical trials. NCT06136741 is a Phase 2b study in adults with moderate-to-severe atopic dermatitis. NCT06340360 is a Phase 2b study in adults with severe alopecia areata. NCT07690371 and NCT07711418 are Phase 3 studies in patients aged 12 and older with moderate-to-severe atopic dermatitis.
Rezpegaldesleukin is not FDA approved. It is an investigational drug that has received Fast Track designation from the FDA, which is intended to expedite its development and review. The drug is still in clinical trials and has not yet been submitted for regulatory approval.
Yes, Rezpegaldesleukin is also known as NKTR-358. Clinical trial records for the Phase 3 studies of atopic dermatitis refer to the drug as NKTR-358, while earlier Phase 2 trials use the name Rezpegaldesleukin. Both names refer to the same investigational compound.