This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.
Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline
Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms ≥ 12 months prior to Screening as determined by the Investigator through patient interview and/or review of medical history at the Screening Visit
IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline
≥ 10.0% of BSA involvement at Screening and Baseline
Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy
Are currently experiencing or have a history of unstable course of AD
History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit.
Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal
Parallel
Rezpegaldesleukin
DrugPharmaceutical form: Injection solution Route of administration: subcutaneous
Placebo
DrugPharmaceutical form: Injection solution Route of administration: subcutaneous
6
Treatment groupsSee each treatment group below.
US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Number of participants at week 6 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants 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.
Number of participants at week 24 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants 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.
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