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

Phase 2

Recruiting

• Conditions: Moderate to Severe Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: Rezpegaldesleukin

• Registration Number: NCT06136741
• Lead Sponsor: Nektar Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study Start: 2023-11-15
• Study First Posted: 2023-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-05-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 396

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16	Week 0 and Week 16	The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.

Secondary Outcome Measures

Name	Time	Method
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	Week 0 and Week 16	The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
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	Week 0 and Week 16	The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)	Week 0 and Week 16	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)	Week 0 and Week 16	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)	Week 0 and Week 16	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value	Week 0 and Week 16	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value	Week 0 and Week 16	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Mean change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)	From Week 0 through Week 104	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Mean percent change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)	From Week 0 through Week 104	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
Mean change from baseline over the period between week 0 and week 104 in SCORAD	From Week 0 through Week 104	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Mean percent change from baseline over the period between week 0 and week 104 in SCORAD	From Week 0 through Week 104	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
Mean change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement	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	From Week 0 through Week 104
Rezpegaldesleukin plasma concentration assessed throughout the study	Through end of study (week 104)
Incidence of Serious Adverse Events (SAEs)	Through end of study (week 104)
Incidence of Treatment Emergent Adverse Events (TEAEs)	Through end of study (week 104)

Trial Locations

Locations (4)

Nektar Investigative Site; 🇪🇸 Zaragoza, Spain

Nektar Investigative Site 5701; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Nektar Investigative Site 5703; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Nektar Investigator Site; 🇵🇱 Kraków, Poland