A Phase 2 interventional study of Rezpegaldesleukin and Placebo in Moderate to Severe Atopic Dermatitis, sponsored by Nektar Therapeutics. Active, not recruiting at 107 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Nektar Therapeutics · Phase 2, Interventional, and Treatment
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 396 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic 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.
AD disease severity at screening and randomization:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Placebo every 2 weeks during the induction period
Drug: Placebo
Placebo every 4 weeks during the maintenance period
Drug: Placebo
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Also known as: NKTR-358, REZPEG, LY3471851 (formerly)
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and at least a 2-point reduction from their baseline value
The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)
The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)
The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)
The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of patients with a 4-point or greater Itch NRS at baseline
The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value
The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value
The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 16
Mean change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)
The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Time frame: From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)
The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Time frame: From Week 0 through Week 104
Mean change from baseline over the period between week 0 and week 104 in SCORAD
The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Time frame: From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in SCORAD
The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Time frame: From Week 0 through Week 104
Mean change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement
Time frame: From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement
Time frame: From Week 0 through Week 104
Rezpegaldesleukin plasma concentration assessed throughout the study
Time frame: Through end of study (week 104)
Incidence of Serious Adverse Events (SAEs)
Time frame: Through end of study (week 104)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through end of study (week 104)
Showing the first 100 of 107 sites across 10 countries. Choose a country and city above to see the rest.
Plan to share: No
Ran from Nov 2023 to primary completion in May 2025, 17 months.
Of 195 industry-sponsored phase 2 interventional studies under Dermatitis, Atopic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's 17 months is above that.
Counting every sponsor, half of 223 studies reached it within 14 months; a quarter within 10 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rezpegaldesleukin