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Moderate to Severe Atopic DermatitisPhase 2REZOLVE-ADNCT06136741

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 2 study testing Rezpegaldesleukin in people with Moderate to Severe Atopic Dermatitis, run by Nektar Therapeutics at 107 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Moderate to Severe Atopic Dermatitis
What is being tested?
Rezpegaldesleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
107 sitesin 10 countries
Study dates
15 Nov 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (from at least 18 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.
  • AD disease severity at screening and randomization:
  • EASI of 16 or higher
  • IGA of 3 or 4
  • BSA of 10% or more
  • Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
Show all 9Show fewer
  • Able to complete patient questionnaires.
  • Able and willing to comply with requested study visits and procedures.
  • Able and willing to provide written informed consent.

Who cannot join

  • Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
  • Other skin conditions that would interfere with assessment of AD
  • Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
  • Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.
  • Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization).
  • Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Show all 9Show fewer
  • Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
  • Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
  • Concurrent participation in any other investigational clinical study.

Trial locations and contacts

107 sites in 10 countries.

107 sites in 10 countries

United States28 sites

  • Nektar Investigative Site

    Bellaire, Texas, 77401

  • Nektar Investigative Site

    Bryant, Arkansas, 72022

  • Nektar Investigative Site

    Clarksville, Indiana, 47129

  • Nektar Investigative Site

    Cypress, Texas, 77429

  • Nektar Investigative Site

    Fairborn, Ohio, 45324

  • Nektar Investigative Site

    Flint, Michigan, 48532

  • Nektar Investigative Site

    Fountain Valley, California, 92708

  • Nektar Investigative Site

    Frisco, Texas, 75034

  • Nektar Investigative Site

    Hialeah, Florida, 33016

  • Nektar Investigative Site

    Hollywood, Florida, 33021

  • Nektar Investigative Site

    Indianapolis, Indiana, 46202

  • Nektar Investigative Site

    Las Vegas, Nevada, 89106

  • Nektar Investigative Site

    Los Angeles, California, 90017

  • Nektar Investigative Site

    Los Angeles, California, 90025

  • Nektar Investigative Site

    Los Angeles, California, 90057

  • Nektar Investigative Site

    Louisville, Kentucky, 40241

  • Nektar Investigative Site

    Marietta, Georgia, 30060

  • Nektar Investigative Site

    Mayfield Heights, Ohio, 44124

  • Nektar Investigative Site

    Miami, Florida, 33173

  • Nektar Investigative Site

    Miami Lakes, Florida, 33014

  • Nektar Investigative Site

    Murfreesboro, Tennessee, 37130

  • Nektar Investigative Site

    New York, New York, 10075

  • Nektar Investigative Site

    Santa Monica, California, 90404

  • Nektar Investigative Site

    Spokane, Washington, 99202-1461

  • Nektar Investigative Site

    Spokane, Washington, 99202

  • Nektar Investigative Site

    St. Petersburg, Florida, 33705

  • Nektar Investigative Site

    Tampa, Florida, 33615

  • Nektar Investigative Site

    Troy, Michigan, 48084

Other trials in United States

Poland26 sites

  • Nektar Investigative Site

    Częstochowa, 42-202

  • Nektar Investigative Site

    Gdansk, Pomeranian Voivodeship, 80-382

  • Nektar Investigative Site

    Gdansk, Pomeranian Voivodeship, 80-546

  • Nektar Investigative Site

    Gdynia, Pomeranian Voivodeship, 81-537

  • Nektar Investigative Site

    Iława, 14-200

  • Nektar Investigative Site

    Katowice, 40-040

  • Nektar Investigator Site

    Krakow, 30-033

  • Nektar Investigative Site

    Krakow, 30-727

  • Nektar Investigative Site

    Krakow, 31-011

  • Nektar Investigative Site

    Lodz, 90-127

  • Nektar Investigative Site

    Lodz, 90-436

  • Nektar Investigative Site

    Poznan, 60-702

  • Nektar Investigative Site

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Nektar Investigative Site

    Szczecin, 71-500

  • Nektar Investigative Site

    Tarnów, 33-100

  • Nektar Investigative Site

    Warsaw, Masovian Voivodeship, 00-874

  • Nektar Investigative Site

    Warsaw, Masovian Voivodeship, 02-672

  • Nektar Investigative Site

    Warsaw, Masovian Voivodeship, 02-953

  • Nektar Investigative Site

    Warsaw, 01-142

  • Nektar Investigative Site

    Warsaw, 02-507

  • Nektar Investigative Site

    Warsaw, 02-962

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 50-220

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 51-685

  • Nektar Investigative Site

    Wroclaw, 50-566

  • Nektar Investigative Site

    Wroclaw, 51-503

Other trials in Poland

Germany12 sites

  • Nektar Investigative Site

    Augsburg, Bavaria, 86150

  • Nektar Investigator Site

    Augsburg, Bavaria, 86179

  • Nektar Investigative Site

    Bad Bentheim, Lower Saxony, 48455

  • Nektar Investigative Site

    Berlin, 10789

  • Nektar Investigative Site

    Berlin, 13353

  • Nektar Investigative Site

    Darmstadt, 64283

  • Nektar Investigative Site

    Erlangen, Bavaria, 91054

  • Nektar Investigative Site

    Frankfurt, 60590

  • Nektar Investigative Site

    Leipzig, Saxony, 4103

  • Nektar Investigative Site

    Lübeck, 23538

  • Nektar Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Nektar Investigator Site

    München, 80337

Other trials in Germany

Canada11 sites

  • Nektar Investigative Site

    Barrie, Ontario, L4M 7G1

  • Nektar Investigative Site

    Calgary, Alberta, T2J 7E1

  • Nektar Investigative Site

    Edmonton, Alberta, T6H 4J8

  • Nektar Investigative Site

    Kelowna, British Columbia, V1W 4V5

  • Nektar Investigative Site

    Markham, Ontario, L3P 1X3

  • Nektar Investigative Site

    Peterborough, Ontario, K9J 5K2

  • Nektar Investigative Site

    Québec, Quebec, G1W 4R4

  • Nektar Investigative Site

    Richmond Hill, Ontario, L4B 1A5

  • Nektar Investigative Site

    Surrey, British Columbia, V3V 0C6

  • Nektar Investigative Site

    Toronto, Ontario, M3H 5Y8

  • Nektar Investigative Site

    Toronto, Ontario, M4W 2N2

Other trials in Canada

Bulgaria10 sites

  • Nektar Investigative Site

    Dupnitsa, Kyustendil, 2600

  • Nektar Investigative Site

    Lovech, 5500

  • Nektar Investigative Site

    Pleven, 5800

  • Nektar Investigative Site

    Sevlievo, Gabrovo, 5400

  • Nektar Investigative Site

    Sofia, Sofia-Grad, 1407

  • Nektar Investigative Site

    Sofia, Sofia-Grad, 1431

  • Nektar Investigative Site

    Sofia, Sofia-Grad, 1592

  • Nektar Investigative Site

    Sofia, Sofia-Grad, 1784

  • Nektar Investigative Site

    Sofia, 1463

  • Nektar Investigative Site

    Sofia, 1510

Other trials in Bulgaria

Australia7 sites

  • Nektar Investigative Site

    Campbelltown, South Australia, 5074

  • Nektar Investigative Site

    Darlinghurst, New South Wales, 2010

  • Nektar Investigative Site

    East Melbourne, Victoria, 3002

  • Nektar Investigative Site

    Kogarah, New South Wales, 2217

  • Nektar Investigative Site

    Melbourne, Victoria, 3004

  • Nektar Investigative Site

    Westmead, New South Wales, 2145

  • Nektar Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain5 sites

  • Nektar Investigative Site

    Alicante, 3010

  • Nektar Investigative Site

    Córdoba, 14004

  • Nektar Investigative Site

    Granada, 18014

  • Nektar Investigative Site

    Seville, 41009

  • Nektar Investigative Site

    Zaragoza, 50009

Other trials in Spain

Czechia4 sites

  • Nektar Investigative Site

    Brno, 602 00

  • Nektar Investigative Site

    Pardubice, 530 02

  • Nektar Investigative Site

    Prague, 100 34

  • Nektar Investigative Site

    Prague, 150 00

Other trials in Czechia

Croatia3 sites

  • Nektar Investigative Site

    Ivanić-Grad, 10310

  • Nektar Investigative Site 5701

    Zagreb, City of Zagreb, 10000

  • Nektar Investigative Site 5703

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Hungary1 site

  • Nektar Investigative Site

    Gyula, Bekes County, 5700

Other trials in Hungary

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)

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.

Being tested
Rezpegaldesleukin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RezpegaldesleukinDrug

    Also called NKTR-358, REZPEG, LY3471851 (formerly)

    Pharmaceutical form: Injection solution Route of administration: subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Injection solution Route of administration: subcutaneous

Study groups in NCT06136741
Study groupRoleWhat they receive
Arm AExperimentalRezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
Receives: Drug: Rezpegaldesleukin
Arm A1ExperimentalRezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin
Arm A2ExperimentalRezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin; Drug: Placebo
Arm BExperimentalRezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
Receives: Drug: Rezpegaldesleukin; Drug: Placebo
Arm B1ExperimentalRezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin
Arm B2ExperimentalRezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin; Drug: Placebo
Arm CExperimentalRezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
Receives: Drug: Rezpegaldesleukin
Arm C1ExperimentalRezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin
Arm C2ExperimentalRezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin; Drug: Placebo
Arm DPlacebo comparatorPlacebo every 2 weeks during the induction period
Receives: Drug: Placebo
Arm D1Placebo comparatorPlacebo every 4 weeks during the maintenance period
Receives: Drug: Placebo
Escape Therapy (open-label)ExperimentalRezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
Receives: Drug: Rezpegaldesleukin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 0 and Week 16

Secondary outcomes (16)

  1. 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.

    Measured: Week 0 and Week 16

  2. 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.

    Measured: Week 0 and Week 16

  3. 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.

    Measured: Week 0 and Week 16

  4. 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.

    Measured: Week 0 and Week 16

  5. 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.

    Measured: Week 0 and Week 16

  6. 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.

    Measured: Week 0 and Week 16

  7. 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.

    Measured: Week 0 and Week 16

  8. 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.

    Measured: From Week 0 through Week 104

  9. 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.

    Measured: From Week 0 through Week 104

  10. 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.

    Measured: From Week 0 through Week 104

  11. 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.

    Measured: From Week 0 through Week 104

  12. Mean change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement

    Measured: From Week 0 through Week 104

  13. Mean percent change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement

    Measured: From Week 0 through Week 104

  14. Rezpegaldesleukin plasma concentration assessed throughout the study

    Measured: Through end of study (week 104)

  15. Incidence of Serious Adverse Events (SAEs)

    Measured: Through end of study (week 104)

  16. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Through end of study (week 104)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start15 Nov 2023
  3. Primary completion6 May 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized initially to 1 of 4 groups (A dose regimen, B dose regimen, C dose regimen, or D dose regimen \[placebo\]) for the blinded induction period. At Week 16, the start of the blinded maintenance period, patients who responded well to treatment will be re-randomized within their previously assigned groups to either maintenance regimen 1 or maintenance regimen 2. At Week 16, patients without an adequate response during the blinded induction period may be assigned to receive open label escape therapy through the maintenance period of the study (up to Week 52); however, patients receiving escape therapy with inadequate improvement in disease severity will be discontinued from the study therapy at Week 32. Any patients enrolled into the blinded maintenance period with acute exacerbation of atopic dermatitis may be eligible to receive open label escape therapy instead.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136741
Sponsor's protocol ID
23-358-05
Acronym
REZOLVE-AD
Status last verified
Aug 2026
First submitted
13 Nov 2023
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silverberg JI, Rosmarin D, Bieber T, Chovatiya R, Gooderham M, Gkalpakiotis S, Reich A, Murrell DF, Skibinska J, Sadick N, Blajic I, Tsianakas A, Fernandez-Penas P, Kern JS, Montero-Vilchez T, Popov TA, Kurian A, Sauder MB, Laquer VT, Chaudhry S, Lee ZH, Hannaway M, Yu D, Liu Y, Fanton C, Lu H, Kotzin B, Tagliaferri M, Zalevsky J, Warren RB; REZOLVE-AD Study Investigators. Rezpegaldesleukin treatment of moderate-to-severe atopic dermatitis (REZOLVE-AD): final results from the 16-week induction period of an international, double-blind, placebo-controlled, randomised phase 2b study. Lancet. 2026 Aug 21:S0140-6736(26)01143-8. doi: 10.1016/S0140-6736(26)01143-8. Online ahead of print.

    PubMed 42628554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rezpegaldesleukin in people with Moderate to Severe Atopic Dermatitis, run by Nektar Therapeutics at 107 sites in 10 countries.

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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Poland, Germany, Canada, Bulgaria and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16 (time frame: Week 0 and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136741, which also lists 1 linked publication.

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 21 Aug 2026.

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