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

NCT06136741
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
396
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Lead sponsor
Nektar Therapeutics
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Start date
2023-11-15
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Number of sites
107
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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. 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.
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Acronym
REZOLVE-AD
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Short title
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-12-31
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First posted
2023-11-18
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Registry last updated
2026-08-21
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Primary completion date
2025-05-06
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Start date
2023-11-15
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Participants
396
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Participant count basis
Estimated
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Planned participants
396
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Protocol amendments
1
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Number of sites
107
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Nektar Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06136741
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ClinicalTrials.gov ID
NCT06136741
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16

    Timeframe: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.

  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

    Timeframe: Week 0 and Week 16

    The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.

  2. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)

    Timeframe: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  3. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)

    Timeframe: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  4. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)

    Timeframe: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  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

    Timeframe: Week 0 and Week 16

    The itch NRS goes from 0 to 10, with higher score indicating more severe itch.

  6. Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value

    Timeframe: Week 0 and Week 16

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  7. Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value

    Timeframe: Week 0 and Week 16

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  8. Mean change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)

    Timeframe: From Week 0 through Week 104

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  9. Mean percent change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)

    Timeframe: From Week 0 through Week 104

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  10. Mean change from baseline over the period between week 0 and week 104 in SCORAD

    Timeframe: From Week 0 through Week 104

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  11. Mean percent change from baseline over the period between week 0 and week 104 in SCORAD

    Timeframe: From Week 0 through Week 104

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

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

    Timeframe: 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

    Timeframe: From Week 0 through Week 104

  14. Rezpegaldesleukin plasma concentration assessed throughout the study

    Timeframe: Through end of study (week 104)

  15. Incidence of Serious Adverse Events (SAEs)

    Timeframe: Through end of study (week 104)

  16. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Through end of study (week 104)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • Able to complete patient questionnaires.

  • Able and willing to comply with requested study visits and procedures.

  • Able and willing to provide written informed consent.

  • 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.
  • 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.
Sources for eligibility
clinicaltrials.gov

  • Nektar Investigative SiteBryant, United States
  • Nektar Investigative SiteFountain Valley, United States
  • Nektar Investigative SiteLos Angeles, United States
  • Nektar Investigative SiteLos Angeles, United States
  • Nektar Investigative SiteLos Angeles, United States
  • Nektar Investigative SiteSanta Monica, United States
  • Nektar Investigative SiteHialeah, United States
  • Nektar Investigative SiteHollywood, United States
  • Nektar Investigative SiteMiami, United States
  • Nektar Investigative SiteMiami Lakes, United States
  • Nektar Investigative SiteSt. Petersburg, United States
  • Nektar Investigative SiteTampa, United States
  • Nektar Investigative SiteMarietta, United States
  • Nektar Investigative SiteClarksville, United States
  • Nektar Investigative SiteIndianapolis, United States
  • Nektar Investigative SiteLouisville, United States
  • Nektar Investigative SiteFlint, United States
  • Nektar Investigative SiteTroy, United States
  • Nektar Investigative SiteLas Vegas, United States
  • Nektar Investigative SiteNew York, United States
  • Nektar Investigative SiteFairborn, United States
  • Nektar Investigative SiteMayfield Heights, United States
  • Nektar Investigative SiteMurfreesboro, United States
  • Nektar Investigative SiteBellaire, United States
  • Nektar Investigative SiteCypress, United States

And 82 more, listed on the interactive page.

Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)