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

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Nektar Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Moderate to Severe Atopic Dermatitis

Treatments

Drug: Rezpegaldesleukin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06136741
23-358-05

Details and patient eligibility

About

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.

Enrollment

396 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

396 participants in 12 patient groups, including a placebo group

Arm A
Experimental group
Description:
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
Treatment:
Drug: Rezpegaldesleukin
Arm A1
Experimental group
Description:
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
Treatment:
Drug: Rezpegaldesleukin
Arm A2
Experimental group
Description:
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
Treatment:
Drug: Placebo
Drug: Rezpegaldesleukin
Arm B
Experimental group
Description:
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
Treatment:
Drug: Placebo
Drug: Rezpegaldesleukin
Arm B1
Experimental group
Description:
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
Treatment:
Drug: Rezpegaldesleukin
Arm B2
Experimental group
Description:
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
Treatment:
Drug: Placebo
Drug: Rezpegaldesleukin
Arm C
Experimental group
Description:
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
Treatment:
Drug: Rezpegaldesleukin
Arm C1
Experimental group
Description:
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
Treatment:
Drug: Rezpegaldesleukin
Arm C2
Experimental group
Description:
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
Treatment:
Drug: Placebo
Drug: Rezpegaldesleukin
Arm D
Placebo Comparator group
Description:
Placebo every 2 weeks during the induction period
Treatment:
Drug: Placebo
Arm D1
Placebo Comparator group
Description:
Placebo every 4 weeks during the maintenance period
Treatment:
Drug: Placebo
Escape Therapy (open-label)
Experimental group
Description:
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
Treatment:
Drug: Rezpegaldesleukin

Trial contacts and locations

143

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Central trial contact

Nektar Recruitment

Data sourced from clinicaltrials.gov

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