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

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 and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) 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 (18 to 70 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 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 resected with no evidence of metastatic disease for 3 years or cervical carcinoma in situ, with no evidence of recurrence within the 5 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 or hepatitis C 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

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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